4Th DIA China Annual Meeting

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WWW.DIACHINA.ORG John J. HU, PhD Vice President and General Manager, United States Pharmacopeia-China

Welcome to 4th DIA China Annual Meeting in Shanghai! This year’s theme, “Collaboration and Innovation in China”, speaks to the fact that future pharmaceutical innovation is about collaboration, and China is an important member of the global innovation community that will contribute to this partnership. Thanks to the outstanding hard work of the program committee and DIA-China staff, we have added exciting new events to this year’s program. We are delighted and hon- ored to have Dr. Yin Li, the commissioner of SFDA, and two distinguished international thought leaders, Dr. David Ho and Dr. Alberto Grignolo as keynote speakers. For the ﬁrst time, SFDA’s Center for Drug Evaluation (CDE), has agreed to conduct a town hall meeting that will allow meeting participants have an open and direct dialog with CDE. Working with China’s SFDA, US FDA and US Department of Commerce, we have also added two new API regulatory workshops at the preconference session. In addition, we are fortunate to be able to invite Japan’s PMDA to provide a special session focus- ing on recent regulatory policy development in the world’s second largest pharmaceutical market. New to this year’s program are dedicated tracks on biological and vaccine development, CRO collaborations and China’s various high-tech parks that offer government incentives for pharmaceutical R&D activities. Through these programs and the DIA-China annual meeting platform, participants representing a wide range of professions – industry, government, academia, asso- ciations - will share views and knowledge, network and build new relationships. This event also brings together exhibitors from an equally wide variety of international stakeholders and partners. ࣌ᆓዂً Please join me at DIA China 2012 in Shanghai and I wish you all an enjoyable and pro- ductive meeting.

John J. HU 4TH DIA China Annual Meeting Program Chairperson Welcome Note Note Welcome ቶჱਬ ዐࡔᅅᄱࡔा঍ୁዐ႐ዷඪ

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ڞ୿૙ᅅბԒߢጉႀኸ ӷཀ ኰᄽ݀ቛڦ৪ኛዐ

ටዖֶᅴ੔ბڦǄඇཀǅࣷമჺ༪Ӭᅃ ǄवଉၚᆌǈᆶၳႠࢅҾඇႠǅᆶ࠲ ںᄱ೗ਸ݀ժऺࣄၠഄ໱ڦ൶ࡔॆ৊ႜںሞᅃ߲ܔx କ঴ඇ൰ਸ݀ጒ઄ )Ǆෙ֫ǈ ᆖၚڦ൶ࡔॆጀ֩ ࢅํा֡ፕ࿚༶ض࠶ᄲ൱ǈཥऺბ࿚༶ǈଣ॔ڦ൶ᇘႎᄱჺ݀ x ༪ஃඇ൰ਸ݀ዐܠටዖֶᅴत ᇱሶڞඇ൰॔࠶ኸڦਸ݀ض൶ࡔॆଣںܠx ೠॏ࠲ᇀටዖֶᅴࢅ ঄๲ጆॆ ๴ᅮ֖ेኁ ࡓރձ๗ ᄱ૙ጆᄽටᇵǈ݆ࡀ๚ခǋጀ֩๚ခටᇵض࣪෌Ǆዐࡔǅჺ৯ਸ݀࣪෌࿴ࡲჺ৯ਸ݀ዐ႐޶ሴට x ᅅิǈิ࿿ཥऺጆᄽටᇵǈଣ മǈฉ๨മࢅฉ๨ࢫਸ݀ටᇵǈԈઔ,7ටᇵǅضࢲᕿঞ๲ x ዆ᄱ߾ᄽටᇵǄଣ ᄱ૙ዐ႐ዷඪ x ࢇཞჺ৯ऐࠓضዐࡔၹࢅᅅᇾଣ ǅڪx አުऐࠓǄසᄱ೗อೠዐ႐ H. M. James HUNGձ๗ x ბຍჺ৯ऐࠓ ׊تتெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ิ࿿ཥऺ ૚࡛ᄊঞ๲ ๬ᄓऐࠓዷඪ Ǆඇཀǅࣷമჺ༪Ӭܾضෙᅅᇾᄱ࿿ଣڼბٷԛ৙ (࿵֫ǈ ჺ৯໯ޭ໯׊ضბଣٷԛ৙ ࡀᄲ൱ᇑॠֱ݆ڦBob POWELLձ๗ ᄱ೗ᇱଙᄱ ᄱ૙ߛपࠥ࿚ضஆ๧዆ᄱᆶ၌ࠅິǄዐࡔǅଣ ྦྷಶ ঄๲ጆॆ ࠶૙ਆᄱ೗อೠዐ႐ᄽခ࠶૙ևၹۙᇵ۽ዐࡔࡔॆ๋೗ᄱ೗॔ John D. AYRESձ๗ ྦྷ࿴ԍձ๗ ૝ઠ዆ᄱǄெࡔǅඇ൰࣒ኁҾඇߛपጺ॔ ெࡔఐਖ਼ࠅິఐਖ਼ჺ৯ํᄓ๪ิ࿿ཥऺᇑჺ৯ਦ֧੔ბևჱ໿൶ጺ॔ Jeffrey GREN ჺ༪Ӭ঻ถ ெࡔฆခևԍॳၩݯ೗Ӹࠅ๪ዷඪ ዐெฆஹ૴྿ࣷᄱ೗߾ፕፇெݛ૴ဝዷဝ ࡺਯࡔ ڦ൶ࡔჺ݀ᄱ೗ᅙঢ়ᆶକ௽ඓںܠᆖၚतڦටዖֶᅴܔৎๆ౎ઠǈࡔाฉ ටዖֶ ࣪෌ཨጨᆶ၌ࠅິඇ൰ഓᄽҾඇևჱ໿൶ጺ॔ڦٷ੔ბණ๎ǈनሞदթĂᄱ೗वଉၚᆌĂଐၳࢅҾඇݛ௬٪ሞጣ࢔ ኸڦ࠲ᇀᄱ೗ᆶၳႠ ) +&,ڟݒᆙںණኪுᆶ࢔ࡻڦᅴֶܔ๟ኄၵڍᅴă ǅǈᄺுᆶሞࡔॆ֫ Susanne KEITELձ๗ڦӲԨ๟ሞኄၵණኪኮമႚׯ)ڦ౎ᇱሶዐǄڞ द ౹ዞ૙๚ࣷ౹ዞᄱ೗ዊଉࢅᅅଐׂ೗ਆਆ׊ڦᆯᇀටዖփཞׂܸิڦᇱሶዐ༹၄ăԨჺ༪ӬॽԒߢᅙঢ়ኪၬڞኸڦ௬ ዘᄲᅪᅭăԨӬᄺॽ༪ Chin Chin LIM ձ๗ڦթĂᄱ೗वଉၚᆌĂଐၳᅜतҾඇႠփཞሞ੔ბฉ ᅅࣅბत࿿૙ბํᄓ๪ዷඪ݆تᄱ೗ਸ ႎेೢ࿐ิ੔ბਆᆌᆩ੔ბև݆ᅅ੔ბڦටዖֶᅴ࿚༶ڟᇱሶ๢ᆩႠǈᅜत੊୯ڞᄱ೗ጀ֩ኸڦஃࡔॆ֫௬ ණڦփཞ๟ႎৎٷदթࢅᄱ࿿वଉၚᆌࣷሰׯ࢔ܔටዖֶᅴܔၜణă६ᇀ݀ Steven WOLFGANG ձ๗ ضଣڦᇀዖፃֶᅴܔණ๎࣏ࣷփ܏݀ቛăఫ஺ǈڦටዖֶᅴܔǈ੗ᅜᇨ९๎ ૙ޭپ߾ፕᆶనၵǛ ெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ᄱ೗Ҿඇྜኝतቻ࣮ևᇑํแኴႜևڦ๬ᄓǈ॔࠶ኁࢅჺ݀ኁ߳ጲ և׊ ӸӬణՔ ቧ࿀ິ׊ ࠶૙ਆᄱ೗ጀ֩ິ۽ዐࡔࡔॆ๋೗ᄱ೗॔ x ණ๎ᇑदթǄิ࿿ბǈට੨ბǈ݀թ୲ࢅຶྨ୲ǅǈᅜतᇑᄱ૙ᄱ࿿

ჺ༪Ӭ঻ถ ๴ᅮ֖ेኁ ࠶۽ኄ๟ᆯዐெฆஹ૴྿ࣷᄱ೗߾ፕፇǈெࡔฆခևतዐࡔࡔॆ๋೗ᄱ೗॔ ටᇵǖڦჺ৯ଶᇘ߾ፕضჺ༪ࣷăዐ ٗ๚ᇀူຎଣڦॠֱ۽࠶ࢅ॔॔ڦᄱ೗ᇱଙᄱܔኍڦ૙ਆǄ6)'$ǅ૴ࢇਉӸ ࠶૙ࢅሏႜضᄲ൱ǈํแ x ଣڦᄱ೗ᇱଙᄱ॔࠶ܔࡔ6)'$ࢅெࡔ)'$࠳ᇵॽ৽ዐெມݛణമ ዺޤ7ጆᄽत,ضx ଣ ڦጒ઄৊ႜ঻ถăᆯ౹ዞतჱዞᄱ೗॔࠶࠳ᇵतੵࡔ዆ᄱࠅິጨศጆॆፇׯ ႑တضᄱ೗ᇱଙᄱ॔࠶ǈॠֱǈ཈቟ǈԈઔᄱ೗ᇱଙ x ଣڦጆॆፇᄺॽ༪ஃඇ൰ݔྷా ֱ॔ض࿚༶ăጆॆᇑ֖ࣷኁᄺॽ৽සࢆेഽඇ൰ x ଣڪऍሰ्ᇱଙᄱٶᄱྪฉၨ๳ᅜत ࠶ݛ݆ࢅ཰০ă x ᄱአ๚ခ॔ڦݛࢇፕ৊ႜᇶጞ༪ஃǈࠌฆᆶၳܠڦݛ௬ Ⴞײx ຕ਍࠶૙ࢅ ခฆ࠶૙ࢅኧ׼ޜضጱଣۉ ӸӬణՔ x x ᄱ೗ჺ݀ रຍኧ׼ڦჺ৯ऺ໙ऐࣅဣཥ၎࠲ضx କ঴ெࡔतഄ໱ࡔॆᄱ೗ᇱଙᄱ॔࠶ఇ๕ x ᇑଣ ࠶ቛྭ॔ڦᇱଙᄱܔ$'(x କ঴6 ܈႑ඪڦx ༵ߛዐࡔׂᇱଙᄱᆩᇀ዆व ዐࡔᇱଙᄱࣅბ೗ Ǆඇཀǅࣷമჺ༪Ӭ຺ڦ࿄ঢ়಼ጚܔණ๎ǈेഽڦᇱଙᄱዊଉԍኤܔx ༵ߛ ኴ݆۽॔ڦᆩᇀ዆वิׂईሰ् *ෙ֫ǈ ዘᄲႠڦऍሰ्ᇱଙᄱٶx ණ๎ਸቛࡔाࢇፕ ض๯೺ଣ ๴ᅮ֖ेኁ ჺ༪Ӭዷ׼ ǅڪॠֱටᇵᅜतᄱॠටᇵ۽x ॔࠶ටᇵǄอೠටᇵĂ॔ ᅅბձ๗چx $3,ิׂഓᄽටᇵ ቧ x ᄱ೗ჺ݀੔रටᇵࢅ࠶૙ኁ ݛܷᅅᄱ݀ቛᆶ၌ࠅິۭ๚׊ग़ጺ֋ x ዊଉԍኤࢅዊଉ੦዆ǋॠᄓጆᄽටᇵ ዬ૬ࢤ߾ฆ࠶૙ຬ๗ Ǆฉ࡛ǅᅅᄱ੔रᆶ၌ࠅິ๯ဝኴႜ࠳ٳࠃᆌฆ ๔ڦx ༵ࠃ६՚्ᄱतփࢇ߭ᇱଙᄱॠ֪रຍ

঄๲ጆॆ Ǆඇཀǅࣷമჺ༪Ӭෙ ࿵֫ǈ- ࢲᕿঞ๲ ᄱ૙ዐ႐ዷඪض߁ ዐࡔၹࢅᅅᇾଣڦ๬ᄓࠓॐዐ˖ऺ໙ऐࣅဣཥᄓኤضጱଣۉබࢇ*&3ዊଉࡀݔᇀ ౒ᇑํ७ ঁᰵᢢᅅბձ๗ ॿ໋࢛෌዆ᄱᆶ၌ࠅິᅅბኴႜጺ॔ ঄๲ጆॆ ଠॆഋᅅბձ๗ ዐ႐ዷඪضᅅᇾ዗ୀ੔ǈ,೺ଣٷ໼ྗ໼ Helena. Van den DUNGEN ౷ࣀ዆ᄱǄ෌๗ǅ'6 (ዊଉԍኤඇ൰޶ሴට Anthony TOLCHERᅅბձ๗ ჺ৯ጺ॔ضெࡔ67$5786ଣ Earl HULIHANঞ๲ ᅅბձ๗چெࡔ(:+XOLKDQጧკࠅິዷᄲࢇअට ቧ ݛܷᅅᄱ݀ቛᆶ၌ࠅິۭ๚׊ग़ጺ֋ ձ๗جି ൶݀ቛጺ॔ ჺ༪Ӭ঻ถںዐࣀٷ0HGLGDWD6ROXWLRQV:RUOGZLGH Beat E. WIDLERձ๗ ࠶૙ਆǄᅜူ०׬6)'$ǅ۽ೠॏႎᄱᅙঢ়ԥዐࡔࡔॆ๋೗ᄱ೗॔ڦ6FKLHPDQQࠅິࢇअට ੔ბᆶၳ ෌๗:LGOHU ٝܔჺ৯ዊଉ࠶૙ࣷᅱđฉምْഽۙăኄضĐࡔॆଣڦሞ౎ሆනቻਸ ༬՚ื༵ڦॺ૬ǈኝ༹ీ૰ڦႎࡔॆظခᇀޜਸ݀ժڦႎᄱ࿿đظٷჺ༪Ӭ঻ถ ৊Đዘ ૰༵ืਏᆶዘᄲᅪᅭăీڦ๟ሞዐࡔ৊ႜ๯ْට༹๬ᄓǄ०׬),+ǅ ܔ3ࢅᅃဣଚ࿔ॲࡀۨǈਸቛ&*ڦ౎ᅜઠǈ࿐ิևࢅ6)'$Ӱքକዐࡔ Ⴞײ߳ዖᆌᆩڦჺ৯ضଣڟሏᆩ܈ጱຕ਍࠶૙ኟᅜट੺໏ۉऺ໙ऐࣅဣཥࢅ ॠֱă۽ණኤࢅዊଉ॔ڦჺ৯ऐࠓضჺ৯ă ଣضଣڦᆌᆩᅙޮ߃କඇ൰ᅜฉڦጱຕ਍֑णဣཥǄ('&ǅۉዐă ऺ໙ऐࣅဣཥ๑ᆩڦჺ৯ዐضଣܠഐ๔঩܎ă࢔تᆌᆩชڦ&')ܔዐࡔణമ ೺,ܔ๬ᄓยऺǈᅜतضଣڦႎᄱظჺ৯ඓํᆶᅃၵݛ௬Ⴔᄲ߀৊ǈසضଣ ዘᄲႠă඗ܸǈ໱்ྫྫுᆶጀᅪڦ๴๬ኁܔຕ਍ዊଉࢅྜኝႠڟණ๎ۼኁ ݛ௬ăᅺُǈ၎႑ਉӸ๯ْට༹๬ᄓڦ၃࠶૙ీ૰๟Բড཭؜ޅڦ๬ᄓضଣ دײሏᆩǈᅜतᇺڦႾࢅऺ໙ࣅဣཥײጱࣅᆌᆩۉǅڟǄᄺႹ໱்ᅙঢ়ᅪ๎ ࠲॰ยऺᄲ൱ǈํแ཈቟ǈᅜतڟჺ༪Ӭݥ׉Ղᄲăჺ༪ӬాඹԈઔٗۨᅭ ᆖၚăڦຕ਍ዊଉࢅྜኝႠǈतഄթටҾඇႠԍቱ໯ሰׯܔ๼թටຕ਍੗ీ ă6)'$ᇀ౎ሆӰքକĖ࠲ᇀᄱ࿿,೺ଣۅ൶ጆᄽཞႜ঍ୁ࠵ںᇑԨ ݛ݆ڦ๑ᆩኁ்ీ૙঴ऺ໙ऐࣅဣཥᄓኤڦჺ༪Ӭॽ๑ऺ໙ဣཥڦԨْᅃཀ ޿ܔ࠳ᇵڦ$'(ᇱሶǄ๬ႜǅཚኪėǈԨჺ༪Ӭᄺॽᄥ൩6ڞ๬ᄓ࠶૙ኸض ᇀ๢ᆩጒتऺ໙ऐࣅဣཥ৊ႜ߾ፕǈժీࠕփ܏ԍ׼ဣཥڦࢅሏᆩԥᄓኤࡗ ࿔ॲ৊ႜ঴܁ă ยऺĂ֪ڦऺ໙ऐࣅဣཥڦჺ৯ዐضༀăُྔǈԨჺ༪Ӭ࣏ॽ঻ถሏᆩᇀଣ ࿄ઠሏᆩ൵๞ࢅፌॅڦ੗ᅜᇨ९ܔ၄ႜՔጚăཞ้ǈ࣏ॽڦ๬Ăሏႜࢅཽᅣ ӸӬణՔ ༬ႠǈԨჺ༪Ӭॽ༑༪ॺ܀ට༹๴๬ኁ৊ႜჺ৯ኄᅃܔࡀݔᇎᅜ঻ถăएᇀ ᄓኤఇ๕ăڦဣཥضጱଣۉ૬ᅃ߲๢ᆩᇀ߳ૌ ჺ৯ยऺᄲ൱ǈස'/7ǈ07'ǈසࢆ჋ስഐ๔वଉǈضx କ঴),+࠲॰ଣ वଉڦ๬ᄓضසࢆླྀ४,,೺ଣ ࠲॰࿚༶ڦӸӬణՔ x ),+঩܎Ⴔᄲ࠲ጀ ݛ݆ڦ၃࠶૙ޅ x ࿋ںڦx ኪၬऺ໙ऐࣅဣཥᄓኤǄ&69ǅሞ*[3ዐ ت๬ᄓփཞኮض೺ଣ,ڦx ),+ᇑሞॳ੃๴๬ኁࢅթට༹ా৊ႜ ჺ৯ዐضਸ݀ଣܔ69ۨᅭࢅࡀݔǈ༬՚๟ဣཥิంዜ೺Ǆ6/&ǅ&ڥۮ x ा֡ፕ཈቟ํڦ+,(ڦx ዗ୀթට ቨ੦ڦऺ໙ऐဣཥڦ໯ᆩዊଉԍኤ ᇱሶǄ๬ႜǅཚኪė๥ڞ๬ᄓ࠶૙ኸضĖ࠲ᇀᄱ࿿,೺ଣڦx ౎Ӱք Քጚࡀݔࢅዊଉ༬ڦႾǈྺऺ໙ऐࣅဣཥײਏ༹ڦ७ํڗx ॺ૬๢ᆩᇀ࿔ ᅭ ԍቱ܈න׉ሏᆩ༵ࠃߛڦႠ ๬ᄓጒ઄ضଣ+,(ڦ൶ںx ჱዞࡔॆई Ⴔ൱ڦ๬ᄓยዃضĐ၄ํิऄđଣܔx ඓԍऺ໙ऐࣅဣཥ஢ፁᆩࢽ ๬ᄓض዗ୀ,೺ଣ+,(ڦx ሞ໼ྗ৊ႜ Ăࢇཞჺ৯ऐࠓǄ&52VǅĂዐ႐ํᄓ๪Ăࢅጆᄽںჺ৯एضx ᆶዺᇀଣ x ࡣࡔǈႎेೢईၑߗ൧઄ ๬ᄓ߾ፕضခฆටᇵኧ׼ଣޜ

๴ᅮ֖ेኁ ჺ༪Ӭ঻ถ ጆᄽටᇵǖڦჺ৯ଶᇘ߾ፕض๚ᅜူଣٗ ჺ༪Ӭৃ౎๟ምْਉӸăዐࡔᅅბԒߢጉႀටڦߛೠॏڥइڦጆᄽටᇵ ኄ߲࠽ྺኪၬڦ๬ᄓߌ႗඀ض๯೺ଣܔ x Ԓߢፔ؜ዘᄲࠋ၅ăጉႀටᄲ൱ጚԢ߳ዖૌ႙ڦࡔाฉڟ՗݀ྺں࠶૙ࢅሏႜ ኟሞփ܏ضx ଣ ᄇ঄֌ଙǈࡔڦ࿔၅ǈࡔाࣷᅱڦሜکሗኾڦߡॲăԈઔࡔाཞႜอለࡗڦ x ᅅბ๬ᄓ๚ခᅅბࠥ࿚ ჺ৯Ԓߢă৑࠶௅߲ߡॲᆶضଣڦ๬ᄓݛӄǈᅜतᆩᇀࡔाጀ֩ฤ൩ضाଣ ۽๬ᄓ॔ضx ଣ ୿૙ࡀݔጚԢăᅺُǈዐڤڢࢇޙՂႷӀቷۼ๟௅ᅃ߲ߡॲڍx ݆ࡀ๚ခ ഄਏ༹ᄲ൱ǈ ᅅڦ୿૙ڤڢࢇޙණ๎ժፏ๰ړƽǅᆌڦᅅბԒߢጉႀටǄԈઔඇ๘হڦമĂฉ๨മĂገࣅ੔ბǅ ࡔضx ዆ᄱ߾ᄽǄଣ ࿋ᅜڇ࡞ժ໦࡞ጉႀටĂჺ৯ླڟሶǈॽ๑թට࠲ࣉ๴ޏx ࢇཞჺ৯ऐࠓ ბԒߢጉႀࡀݔă ႑ăྰڦࡔॆڦतภत Ԩჺ༪Ӭǈ঄๲ጆॆॽǖ ዘᄲႠڦ୿૙ࡀݔڤڢǄඇཀǅࣷമჺ༪Ӭ࿵ x ঻ถํाӄ૩ഽۙ ᇱሶǈՍᇀ֖ेኁৃࢫ๑ᆩڞࡔाኸڦ࿵֫ǈ+ x ঻ถዘᄲ ୿૙ࡀݔǄ૩ڤڢዘᄲڦፏ๰ړߡॲ้ᆌڦx ኸ؜ጉߡටሞጚԢփཞૌ႙ Ă࡛ՄԒĂ๮ߡǅೌڨჺ৯ԒߢĂ࿔ቌĂࣙض๬ᄓݛӄĂଣض၃ සǈଣޅ$'(࣮ࠥˈੂெࡔڦ༬ӄ૩܀๨ࢅዘႎฉ๨םగᄱ೗ฉ๨ǃٗ ؜Ӳࡀݔኮമࢅኮࢫॠᄓጲวڦ୿૙ڤࢇޙೠࠚࢅ࠶૙ x ๑ჺ༪Ӭ֖ेኁሞศ෇࣮ࠥ ኪ๎ڦሞ޿ݛ௬ቨ࿥ ᅅბጉႀઓవǈኄၵઓڦ୿૙ڤڢࢇޙ঄๲ጆॆ x ࠞ૤ჺ༪Ӭ֖ेኁ༪ஃසࢆ঴ਦ వ཈቟ࣷሞփณํा൧઄ዐ؜၄ ঄๲ጆॆ਩ྺெࡔ)'$ཞඦࣷׯᇵ ݛ๕஢ፁփཞბသႴ൱ăڦۯ঄๲ጆॆॽӀቷׯටბသᇱሶǈ֑ᆩ঄๲ࢅࢻ ă܈ༀڦॽ༹၄࿔ࣅፎዘۯჺ༪Ӭऄ Mark J. GOLDBERGERᅅბձ๗ˈࠅࠌ࿐ิຬ๗ മெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ੇਪׂ೗ևև׊ ӸӬణՔ ெࡔ)'$ཞඦࣷׯᇵ ெࡔჯಢ዆ᄱ݆ࡀአ֧ޭጺ֋ ჺ༪Ӭ঳ຐ้ǈ֖ेኁॽీࠕǖ ᅅბጉႀڦ୿૙ڤڢࢇޙڦፏ๰ࡔाฉණ੗ړᅅბጉႀටᆌڦFlorence HOUNᅅბձ๗ˈࠅࠌ࿐ิຬ๗ x ಒ܏ዐࡔ ࢇ૙Ⴀڦമெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ೠอෙևև׊ ࡀݔ ᇱሶڞࡔाኸڦᅅბጉႀࡀݔڦ୿૙ڤڢࢇޙ࠲ᇀ঻ถڦெࡔ)'$ཞඦࣷࡔाև૴ဝዷဝ x ኪၬዘᄲ ᅅბጉႀࡀݔڦ୿૙ڤڢࢇޙெࡔ෗ܻएᅺࠅິ݆ࡀአ֧ᇑ቟୼ޭጺ֋ x ሞጚԢ߳ዖૌ႙ߡॲ้ǈᆌᆩ ૚ጲ૰ᅅბձ๗ˈࠅࠌ࿐ิຬ๗ อೠፇፇ׊ ๴ᅮ֖ेኁضമெࡔ)'$ႎᄱଣ ெࡔ)'$ཞඦࣷࡔाև૴ဝዷဝ ெࡔఐਖ਼ࠅິǄఐ෭۫ǅႎ႗๨ׇጀ֧֩୼ኴႜጺ॔ x ᅅბጉႀට ๬ᄓᅅิضx ଣ ჺ৯ጆᄽටᇵضჺ༪Ӭ঻ถ x ଣ x ॔࠶ጀ֩๚ခටᇵ ߛपӬǈԈઔ঄ੜևݴĂڦएᇀӄ૩ჺ৯ڦ޿ჺ༪Ӭ๟ྺ೺ᅃཀǄၭ้ǅ ๨ǈፌࢫם༪ஃࢅଁသă঄๲ాඹ๟एᇀெࡔ࠲ᇀᅃ߲ᄱ೗಼ጚฉ๨ǈኮࢫ อೠ࠳ᇵत޶ሴටǈྜඇ֖ڦ$'(ă঄๲ጆॆሼঢ়๟ڢࠅਸԒڦᆼዘႎฉ๨ ăჺ༪Ӭݴྺෙ߲ևݴ৊ႜǈ௅ևݴၭײ࠶ጀ֩ਦ֧ࡗ॔ڦ޿ᄱ೗ܔᇑକ ๨Ċምฉ๨ăם๨ĂᅜतםǈӀቷ้क़ຩႾࣄݴǈनฉ๨಼ጚമĂ಼ጚĊ้ ᆶ࠲୤ڦຕ਍ᅜत)'$ጧკ྿ᇵࣷڟ঻ถኮࢫǈ֖ेኁॽੂ܌௅ᅃևݴ० ၟǈ඗ࢫਸ๔༪ஃईঙ෥ӳᄇă

ӸӬణՔ

ࢅሏᆩإਦ֧ᇱሶएڦx କ঴ெࡔ)'$एᇀ੔ბ ၃૧ᅮݛ݆ࢅ߾ਏޅڦx କ঴ӻዺ॔࠶ਦ֧ ଆࡻ঍ୁڦዘᄲႠǈԈઔ዆ᄱഓᄽᇑ॔࠶ऐࠓኮक़ڦx କ঴ଆࡻอೠࡀݔ ࠏཚ

๴ᅮ֖ेኁ

ጆᄽටᇵܸยڦ๟ྺਏᆶݿ޷ᄱ೗ਸ݀ঢ়ᄓࢅߛ຤ೝᆈᇕీ૰ײԨಢჟੜ ዆ڦ๬ᄓݛӄضࢇঢ়ᄓǖଣްڦǈူଚඪࢆଶᇘڦऺăᅃӯᄲ൱ᆶ౎ᅜฉ ၃ೠࠚ࠶૙ăཞ้ထޅ࠶૙ईᄱ೗ڦ๬ᄓض዆ۨǈଣڦǈᄱ೗ጀ֩቟୼ۨ ۯࢻڦײঢ়ᄓă६ᇀԨಢჟੜڦᆶሞ߾ፕዐईሞࣷᅱ঄သӬᆩᆈ࿔঄ᄇྭ ࡗටǈॽݴׯ߲ၭፇǈᅜԍגටຕႴᄲ੦዆ǈጺටຕփڦኁे֖ܔႠǈ ኤಢჟၳࡕă

Ǆӷཀฉ࿷ǅࣷമჺ༪Ӭ ,࿵֫ǈ ڞ୿૙ᅅბԒߢጉႀኸ

঄๲ጆॆ

Karen Woolley ձ๗ ዐࡔ3URVFULEHᅅଐཚრ๯ဝኴႜ࠳

ཀܾڼ ײ౎ሆන႓೺ܾ_ࣷᅱන

ݴׇࣷᅃ ݴׇܾࣷ ݴׇࣷෙ ݴ຺ׇࣷ ݴׇࣷ࿵ ݴׇࣷୃ ቛ݀ڦჺ৯ᇑሏႜ ݆ࡀ๚ခ &0&*03 ཥऺ ᄱ࿿Ҿඇ &52ضଣ

ᅃׇڼೝႜࣷᅱ

ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ࿵֫ǈ5B+C ࿵֫ǈ5D+E ࿵֫ǈ׊ॿཐ ෙ֫ǈ3C+D ෙ֫ǈࣜࢋཐ ᅃ֫ǈ๘ुཐ ቛ݀ڦतฉ๨ &52ሞዐࡔڦ๬ᄓኸళ ჺ݀ኁᆌ৊ႜض࠶૙ᝩ &'(ᄱ೗ጧკࣷঢ়ᄓ &0&ݛ୼तํ७ ݥଝၳႠଣڦ࠲ᇀ࣮Ԓ୲ ᄱ࿿য়ڦݴၛ तຩᆌยऺኸళ Ⴙ੗้໯׶౷ ڦڥሁณڦᄲஃ ሁܠ" শԒߢǄ39ǅ

˅ᅃ֫ˈࣀဲཐ ၶְ 10:00-10:30

ݴׇࣷᅃ ݴׇܾࣷ ݴׇࣷෙ ݴ຺ׇࣷ ݴׇࣷ࿵ ݴׇࣷୃ ቛ݀ڦჺ৯ᇑሏႜ ݆ࡀ๚ခ &0&*03 ཥऺ ᄱ࿿Ҿඇ &52ضଣ

ׇܾڼೝႜࣷᅱ

ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ࿵֫ǈ5B+C ࿵֫ǈ5D+E ࿵֫ǈ׊ॿཐ ෙ֫ǈ3C+D ෙ֫ǈࣜࢋཐ ᅃ֫ǈ๘ुཐ ჺ৯ǈԈض๬ᄓኸళ ႑ࡽॠ֪ሞႎ้೺ᄱ ภतራ೺ଣض੔ბਦ &0&ݛ୼ࢅํ७ĊĊ ݥଝၳႠଣڦ$'(ॺթට෇ፇ቟୼ ெࡔظዘႎ ጱरۉᄱ૙ბतض၃࠶૙ዐ ઔଣޅፏთᇑዊଉ तຩᆌยऺኸళ ࿿য়শࢅڦतኴႜݛӄ ֧ĊĊ๟૙ၙ࣏๟ *03 52ĊĊሞዐࡔ௬&ڦᆌᆩ ຍڦ ၄ํǛ ཈቟ᇑऐᇜڦଣ

೿֫ˈฉ࡛ཐ ࿷֕

ݴׇࣷᅃ ݴׇܾࣷ ݴׇࣷෙ ݴ຺ׇࣷ ݴׇࣷ೿ ݴׇࣷӗ ႎظჺ৯ᇑሏႜ ݆ࡀ๚ခ &0&*03 ཥऺ ᅧ௭ᇑิ࿿዆೗ ߛႎरຍᇴ൶ضଣ

ෙׇڼೝႜࣷᅱ

࠶૙ਆᄱ೗อೠዐ႐ ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7۽ዐࡔࡔॆ๋೗ᄱ೗॔ ࿵֫ǈ5B+C ࿵֫ǈ5D+E ࿵֫ǈ׊ॿཐ ߾ፕ࣮ࠥᇑቛྭ ঢ়ᄓĂ཈቟ࢅڦਸ݀ ഓᄽॆڦ೿֫ǈฉ࡛ཐ ᄱ೗ჺ৯ਸ݀ۨଉ ᅧ௭ࢅิ࿿዆೗ ഔ๖ڦᅃևݴ ቛྭߴᇎڼႎĊĊظߛཚଉิ࿿ኸՔෲ჋ ᇑ ݀ቛ

˅ᅃ֫ˈࣀဲཐ ၶְ 15:30 - 15:00

ݴׇࣷᅃ ݴׇܾࣷ ݴׇࣷෙ ݴ຺ׇࣷ ݴׇࣷ೿ ݴׇࣷӗ ႎظჺ৯ᇑሏႜ ݆ࡀ๚ခ &0&*03 ཥऺ ᅧ௭ᇑิ࿿዆೗ ߛႎरຍᇴ൶ضଣ

຺ׇڼೝႜࣷᅱ ࠶૙ਆᄱ೗อೠዐ႐ ݴׇࣷ7 ݴׇࣷ7۽ዐࡔࡔॆ๋೗ᄱ೗॔ ࿵֫ǈ5B+C ࿵֫ǈ5D+E ߾ፕ࣮ࠥᇑቛྭ ਸ݀ ӄ૩ჺ৯ࢅጆॆ༪ஃڦ೿֫ǈฉ࡛ཐ ᅧ௭ࢅิ࿿዆೗ ևݴܾڼႎĊĊظᇑ

ෙཀڼ ײ౎ሆන႓೺ෙ_ࣷᅱන

ݴׇࣷᅃ ݴׇܾࣷ ݴׇࣷෙ ݴ຺ׇࣷ ݴׇࣷ೿ ݴׇࣷ৵ ჺ৯ᇑሏႜ ݆ࡀ๚ခ &0&*03 ཥऺ ᅧ௭ᇑิ࿿዆೗ ገࣅᅅბضଣ

࿵ׇڼೝႜࣷᅱ

ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ࿵֫ǈ5B+C ࿵֫ǈ5D+E ࿵֫ǈ׊ॿཐ ෙ֫ǈ3C+D ෙ֫ǈࣜࢋཐ ᅃ֫ǈ๘ुཐ ჺ݀ᇑ಼ጚĊĊ ገࣅ੔ბत༹߲ࣅᆩᄱڦ߁౒ᄓኤ ᅧ௭ڦႎᄱਸ݀ዐ &0&ڦჺ৯ऐࠓ࠶૙ဣཥ ᅅଐഗႁतᄱ೗ഗႁ ᄱ೗዆वضଣ ࠅࠌ࿐ڦยऺ ঴ਦช࿄஢ፁڦࡀᄲ൱ ࢅवଉඓۨ๬ᄓ݆ڦॺ૬ࢅ߀৊ ፇࢇׂ೗ڦ ࢅํ७ ࢅݴဆ ิႴ൱

˅ᅃ֫ˈࣀဲཐ ၶְ 10:00-10:30

ݴׇࣷᅃ ݴׇܾࣷ ݴׇࣷෙ ݴׇࣷๆ ݴׇࣷ೿ ݴׇࣷ৵ ჺ৯ᇑሏႜ ݆ࡀ๚ခ &0&*03 ຕ਍࠶૙ ᅧ௭ᇑิ࿿዆೗ ገࣅᅅბضଣ

ׇୃڼೝႜࣷᅱ

ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ࿵֫ǈ5B+C ࿵֫ǈ5D+E ࿵֫ǈ׊ॿཐ ෙ֫ǈ3C+D ෙ֫ǈࣜࢋཐ ᅃ֫ǈ๘ुཐ ჺ݀ᇑ಼ጚĊĊ ገࣅ੔ბࢅ༹߲ࣅᆩڦ࠶ኸళࢅࡔाຕ਍Ք ᅧ௭॔ &0&ڦ၄ጒᇑ ᄱ೗዆वڦ$'૰ නԨ30ీڦჺ৯ऐࠓضଣ ࠅࠌ࿐ ᄱĊĊӄ૩ჺ৯ࢅጆڦຕ ঴ਦช࿄஢ፁڦჺ৯ضॺย ৃࢫ݀ቛݛၠ ጚĊĊଣ ਍࠶૙ ิႴ൱ ॆ༪ஃ

೿֫ˈฉ࡛ཐ ࿷֕

ݴׇࣷᅃ ݴׇܾࣷ ݴׇࣷෙ ݴׇࣷๆ ݴׇࣷ೿ ݴׇࣷๆᅃ ჺ৯ᇑሏႜ ݆ࡀ๚ခ &0&*03 ຕ਍࠶૙ ᅧ௭ᇑิ࿿዆೗ ᅅბ੔ბ๚ခضଣ

೿ׇڼೝႜࣷᅱ

ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ࿵֫ǈ5B+C ࿵֫ǈ5D+E ࿵֫ǈ׊ॿཐ ෙ֫ǈ3C+D ᅃ֫ǈ๘ुཐ ᅃ֫ǈ๘ुཐ ڞༀ࣍ৣዐᅅბዷۯ ਖ਼୉ੇ༹ࢅဦԇዎଐڇ तഄ໲ዊଉኸ ຕ਍ዊଉĊĊेഽ዆ᄱڦႎ+&, ڦॠֱ቟୼ࢅݛ݆ ႎᄱਸ݀ዐ۽॔ ႎĊĊ ፕᆩظਸ݀ᇑڦ ჺ৯ऐࠓኮضแ ഓᄽᇑଣํڦᇱሶڞ ბĊĊణമᇑৃࢫ ኪ๎ׂ඄ԍࢺ ᅃևݴڼ ၎ࢻದࢇڦक़

˅ᅃ֫ˈࣀဲཐ ၶְ

ݴׇࣷᅃ ݴׇܾࣷ ݴׇࣷෙ ݴׇࣷๆ ݴׇࣷ೿ ݴׇࣷๆᅃ ჺ৯ᇑሏႜ ݆ࡀ๚ခ &0&*03 ຕ਍࠶૙ ᅧ௭ᇑิ࿿዆೗ ᅅბ੔ბ๚ခضଣ

ӗׇڼೝႜࣷᅱ ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ݴׇࣷ7 ࿵֫ǈ5B+C ࿵֫ǈ5D+E ࿵֫ǈ׊ॿཐ ෙ֫ǈ3C+D ᅃ֫ǈ๘ुཐ ᅃ֫ǈ๘ुཐ ਖ਼୉ੇ༹ࢅဦԇዎଐ ᇶጞ༪ஃǖᅅბ๚ခڇ ཈቟ڦतഄ໲ዊଉኸ ຕ਍࠶૙௬ଣڦዊଉ࠶૙ ݠ዆ᄱĊĊ॔࠶཈቟ ,&+ႎڦ๬ᄓዐضଣ ਸ݀၄ํ࣏๟ضႎĊĊ ᇑଣظਸ݀ᇑڦ แ ӄ૩ჺ৯ํڦᇱሶڞ ཥؕยዃ ࢅऐᇜڦဣǈዊଉ༹ ևݴ ഓಐǛܾڼ ၃࠶૙ޅࢅዊଉ

ᅃཀڼ ײ౎ሆන႓೺ᅃ_ࣷᅱන

ࣷᅱ၄ׇጀ֩ ᅃ֫ǈቛཐ

ॠֱ——ፌॅํ७ᇑ֧୼Ǆ༬ᄥᄱ॔ևோጆ༶ࣷǅ۽॔ڦᄱ೗ᇱଙᄱิׂยแ )ෙ֫ǈ ࣌ᆓዂًĂዷኼᄇ঄ĂӰঃᅏ๕ ౎ࣷਸట ೿֫ǈฉ࡛ཐ ࣷዂًٷ x ᆄ૰ᅅბձ๗ ࠶૙ਆਆ׊۽ዐࡔࡔॆ๋೗ᄱ೗॔ x ዷኼᄇ঄ᅃ ᅃᅅბձ๗ˈঞ๲ٷࢆ Ҹጪթჺ৯ዐ႐ዷඪڤ௏ٻბҸ୿ٷெࡔ౨ሀ஍ਖ਼ݤુ Һጪթच࿂৶ଐ݆݀௽ට x ዷኼᄇ঄ܾ Alberto GRIGNOLOձ๗ PAREXELඇ൰ޭጺ֋ ࣷځ࣌ᆓቲ ᅃ֫ǈቛཐ

ཀܾڼ ײ౎ሆන႓೺ܾ_ࣷᅱන ෙཀڼ ײ౎ሆන႓೺ෙ_ࣷᅱන

ჺ৯ᇑሏႜ ҺܷထǄԛ৙ǅᅅଐ੔रᆶ၌ࠅິԛჱतዐࡔ൶ጺঢ়૙ضݴׇࣷᅃ_ଣ

๬ᄓዐթට෇ፇݛ݆तํ७ă੺໏ྜׯթට෇ፇጺ๟ઓవضԨጆׇॽ༪ஃଣ ኴႜీ૰ă঄ኁॽ঻ถǖڦٷऺࣄ዆ۨࢅഽڦǈႴᄲݥ׉ጮဦڦ ݴׇࣷ7_౎ሆනˈ႓೺ܾ թට෇჋้क़৊ႜఇెࢅᇨܔݛ݆ბ߾ਏǈڦᅃ֫ǈ๘ुཐǅ x ࡔॆ๬ᄓዐ႐჋ስೠॏ ࡀࣄڦ৊ႜၜణঢ়ݯࢅጨᇸܓఇ႙ǈኄၵॽᆶዺᇀ๬ᄓჺ৯ཷ֪ "ܠሁڦڥˈሁณڦᄲ࠶૙ᝩஃڦ࠲ᇀ࣮Ԓ୲ ๬ᄓฤ൩ჽض๬ᄓթට෇ፇ֧୼ࢅํ७ǈྺߋฉᅺྺଣضx ሞዐࡔ৊ႜଣ ԍቱڦࠃ༵܈๬ᄓ৊ضଣڦࣷᅱዷ׼ ဃ ࿚ڦࢅ༵؜ۅᄲڦ঄ᄇܔጆॆ঄ኁࢅࣷᅱዷ׼ට৊ႜ༪ஃǈኍڦႌᅅ฾ ᆯঢ়ᄓݿ޷ٻ ፌॅঢ়ᄓăڦႚ๕ࠌၛࡔाࢅࡔాۯࢻڦٴዐࡔĂჱ໿Ăዐ۫तݥዞ൶ᇘߛप ༶ǈᆩ༵࿚ࢅ঴ٷਸ݀ևضԛ৙౷ࣀ዆ᄱᆶ၌ࠅິࡔाଣ ጺ॔ ᆶ૰߾ਏڦ๬ᄓዐೠॏࡔॆ੗ႜႠࢅթට෇ፇᇨ֪ضࡔाଣ ཈቟ኮᅃǈԨጆׇ Jeffrey ZUCKERٷፌڦၳ୲๟ᄱ೗ਸ݀ഓᄽڦਸ݀ࢫ೺঩܎ضߛᄱ೗ଣ༵ ๬ᄓ੗ႜႠतթටቲఠ࠶૙ևߛपጺ॔ǈඇ൰޶ሴටضႎႠݛ݆ୟ০༵ߛၳ୲ă ,1&Ǆெࡔǅଣظڦາྼǈ๑ᆩႎڦॽ৽ُ঻ถසࢆᅜႎ

੦዆ ዐࡔթට෇ፇ֧୼ࢅํ७ᅜํ၄ऐࣷᆫࣅײᇺ Qing ZURAW ᅅ฾ˈ߾ฆ࠶૙ຬ๗ ࿴࡛հ ૬ኁǈጺঢ়૙ǈ๯ဝኴႜ࠳ظெࡔ੔࿔ຯࠅິኴႜᅅბጺ॔ ৛׵&52ࠅິ

ᅈٗႠ ጆॆ༪ஃڦ๬ᄓݛӄضཚࡗरຍ༵ߛଣ Malcolm BURGESSձ๗ ഄ໱ጆॆ ჺ৯ኴႜޭጺ֋ჱ໿൶ضҺ੃ଣ ࣜਭီᅅ฾ ࿋ჱዞ൶޶ሴටڇჺ৯ضጆॆ༪ஃ ෘ౷ݤǄዐࡔǅཨጨᆶ၌ࠅິଣ ႎݛ݆༵ߛ࣮Ԓ୲ظᆩ ݴׇࣷ777_౎ሆනˈ႓೺ܾ ೿֫ǈฉ࡛ཐǅ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ࠶૙ਆᄱ೗อೠዐ႐߾ፕ࣮ࠥᇑቛྭ۽ዐࡔࡔॆ๋೗ᄱ೗॔ ᅃ֫ǈ๘ुཐǅ

ॺթට෇ፇ቟୼तኴႜݛӄ x &'(ኝ༹঻ถظዘႎ x &'(อೠਦ֧ୟ০ ࣷᅱዷ׼ ᇱሶ༹ဣڞx &'(ᄱ೗อೠኸ ିॅᅅ฾

࿚༶ۅჺ৯ඤضx &'(ଣ ๬ᄓၹۙᇵض঴ਦݛӄ஘Ǜሞ๑ᆩଣڦ๬ᄓၹۙᇵ๟ჺ৯ऐࠓጨᇸ࿚༶ض၃੦዆ ଣޅڦضႎᄱଣظ)'& x ๬ᄓၹۙᇵᄽခሞዐࡔضକ঴ଣںܠ௬ଣనၵ཈቟ǛཚࡗՑஃǈདዚࣷ߸้ ၄ጒăڦ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ೿֫ǈฉ࡛ཐǅ Ցஃዷ׼ǖ ࠶૙ਆᄱ೗อೠዐ႐߾ፕ࣮ࠥᇑቛྭ Ⴘౢᅅბձ๗ˈ߾ฆ࠶૙ຬ๗۽ዐࡔࡔॆ๋೗ᄱ೗॔ ჺ৯๚ᄽև޶ሴටض੔࿔ຯࠅິޭጺ֋ǈዐࡔଣ x &'(ኝ༹঻ถ Ցஃມݛǖ x &'(อೠਦ֧ୟ০ ೝ࿔ࣱ ᇱሶ༹ဣڞx &'(ᄱ೗อೠኸ ฉ࡛ൎܻဇᅅᄱ੔रጧკᆶ၌ࠅິጺঢ়૙ ࿚༶ۅჺ৯ඤضx &'(ଣ ձ๗᤺֔ ሏᆐևߛपጺ॔ض၃੦዆ ᄘ෧ഽิǄዐࡔǅࡔाଣޅڦضႎᄱଣظ)'& x

ݴׇࣷ7_౎ሆනˈ႓೺ෙ ݴׇࣷ7_౎ሆනˈ႓೺ෙ ᅃ֫ǈ๘ुཐǅ ᅃ֫ǈ๘ुཐǅ ॠֱ቟୼ࢅݛ݆ბüüణമᇑৃࢫ۽॔ ॺ૬ࢅ߀৊ڦჺ৯ऐࠓ࠶૙ဣཥضଣ

ࣷᅱዷ׼ ࣷᅱዷ׼ ࣀᅅ฾ר ૚࡛ᄊঞ๲ ዊଉ॔੦൶ᇘঢ়૙ض๬ᄓऐࠓዷඪ ߬ન໎๏ਖ਼Ǆዐࡔǅଣضෙᅅᇾᄱ࿿ଣڼბٷԛ৙ ჺ৯໯ޭ໯׊ضბଣٷԛ৙ ຕ਍॔ײዐ႐ᇺܔ࠶૙ਆኍ۽ࢅዐࡔ๋೗ᄱ೗॔ٷକ঴ெࡔ)'$Ă౹௑Ăेధ ჺ৯ኁࢅฤӸኁॠܔႎ֧୼ࢅݛ݆ăݴၛ॔࠶ևோڦዘᄲԍቱăሞኄ߲ጆ༶ ֱǈሞ*&3ॠֱዐ໯֑ᆩڦჺ৯ض࠶૙ဣཥ๟ํแߛዊଉଣڦں๬ᄓएضଣ ڦ๬ᄓضሞᆌᆩႎरຍူਸቛଣܔ૙঴݆ࡀևோںঢ়ᄓǈཚࡗ༪ஃ߸ൣညڦֱ ࠶૙ဣཥăڦॺ૬ߛዊଉں๬ᄓएضዐǈ࿢்ॽ༪ஃසࢆሞଣ ᄲ൱ă ፕᆩڦჺ৯ዐAROǄბຍჺ৯ऐࠓǅضଣ ᇱሶǅڞ࠶ݛ๕Ǆ๬ႜኸ۽ڦ၃ޅ࠶ǖᅃዖएᇀ॔ڦ๬ᄓضଣܔ Denise CLARKE-HUNDLEY ૧ჱǅሏᆐևߛपጺ॔ Byungja Marcianteٷ൅ዎᅅბჺ৯ዐ႐ǄӐ ॠֱᇵتெࡔ)'$ฉ࡛Ӹ๚ ዐ႐๬ᄓ႑တ࠶૙ဣཥضƯ೺ଣ

ॠֱǈ၄ጒᇑৃࢫ݀ቛ۽॔ڦሷᇸঞ๲ ᆈࡔᄱ॔ਆǄ0+5$ǅି ᄱ૙ჺ৯๪ዷඪضዐࡔට௷঴ݣਬᅅᇾଣ Vincent YEUNGձ๗ˈ߾ฆ࠶૙ຬ๗ ॠֱᇵ۽ཀྵፕᆩ ᆈࡔᄱ೗ᅅଐׂ೗॔࠶ਆ*&3ևோ޶ሴටǈߛप॔ټڦჺ৯ዐضतഄሞዐࡔݬҵଣ*721&

3ॠֱ&*ڦ࿐ิևٷ୥ສঞ๲ ेధ ᅅბዐ႐ዷඪضბ޹ຌႤ੔ᅅᇾǄฉ࡛๨Ⴄ੔ᅅᇾǅݬև዗ୀଣٷฉ࡛঍ཚ ዐࡔੇҵၹࣷݬҵጆᄽ྿ᇵࣷޭዷඪ྿ᇵ Alicja KASINAձ๗ ࿐ิևٷధे

࠶૙ਆ঄ኁᅙᄥ൩۽ݴׇࣷ7_౎ሆනˈ႓೺ෙ ዐࡔࡔॆ๋೗ᄱ೗॔ ᅃ֫ǈ๘ुཐǅ ጆॆ༪ஃ ૰ॺย ᅜฉ঄ኁᅜतీڦჺ৯ऐࠓضଣ ࣷᅱዷ׼ Earl HULIHANঞ๲ ெࡔ(:+XOLKDQጧკࠅິዷᄲࢇअට ձ๗᤺֔ ሏᆐևߛपጺ॔ضᄘ෧ഽิǄዐࡔǅࡔाଣ ݴׇࣷ7_౎ሆනˈ႓೺ෙ ჺ৯ऐࠓ٪ሞనضჺ৯ዐ༬՚๟,೺ჺ৯ࢅᅧ௭๬ᄓଣضሞํแߛዊଉଣ ᅃ֫ǈ๘ुཐǅ ঢ়ᄓăڦჺ৯ऐࠓీ૰༵ืضၵֶਐ఼Ǜሞኄ߲ጆ༶ዐ঄ኁ்ॽᇑࣷݴၛଣ ၃࠶૙ޅཥؕยዃࢅዊଉڦዊଉ࠶૙༹ဣˈዊଉڦ๬ᄓዐضଣ ፕᆩڦ๬ᄓऐࠓ༵ืჺ৯ీ૰ݛ௬ض$52ሞኧ׼ଣ Jean Paul DESLYPERE ࣷᅱዷ׼ ႎेೢ3KDUPDWUDLQඇ൰ჺ৯໯๯ဝኴႜ࠳ ૚൪ࢤᅅ฾ ൶޶ሴටں࣪෌ᅅბዊଉԍኤևჱዞ ჺ৯ض೺ଣ,ڦߛዊଉ ၃࠶૙Ǆ450ǅᅙঢ়ޅཥؕยዃǄ4E'ǅᅜतዊଉڦዬ૬ࢤ߾ฆ࠶૙ຬ๗ ዊଉ࠶૙༹ဣǈዊଉ ᇱሶǈतഄሞ*&3ڦ๬ᄓዐ࠽ݘᆌᆩăᄇ঄ኁॽ঻ถኄၵ༹ဣࢅ࠶૙ضǄฉ࡛ǅᅅᄱ੔रᆶ၌ࠅິ๯ဝኴႜ࠳ ሞଣٳ๔ ߾ਏăڦǈժݴၛᅃဣଚ੗ᆩتᆌᆩᅜतᅮڦࢅ39ዐ ཞඦǈᅜतᅙঢ়ਏᆶํ७ঢ়ᄓڦएԨኪ๎ࢅํ७ঢ়ᄓڥፕᆩǄ*&3ዐ႐ǅ Ԩጆׇ๢ࢇᇀထྭइڦ࿋ڇ๬ᄓض૰ĊĊᄱ࿿ଣీڦ๬ᄓضߛଣ༵ ཞඦ்ăڦฉᆶ໯݀ቛࢅݴၛঢ়ᄓإժᇼᅪሞُए ૚ࣀݚᅅბձ๗ ฉ࡛๨৛ห࿐ิዐ႐৛ห੔ዷඪᅅ฾ ዘᄲႠڦዊଉ࠶૙༹ဣ Ցஃࣷ Deborah DRISCOLL ჺ৯ၹۙᇵ ࣪෌ඇ൰ᅅბዊଉԍኤևޭጺ֋ضዐࡔଣ

ெࡔ෗ܻएᅺࠅິ݆ࡀአ֧ᇑ቟୼ޭጺ֋ ࠶૙ݛ݆ڦ൶ں๬ᄓዊଉԍኤǄ&4$ǅሞჱ໿ضཥؕยዃǖଣڦዊଉ ٯႎਉڦJoanne NORTH ெࡔ)'$&'(5ੵბ੔૴ဝాჺࣷऐ዆——ᅃ߲༵ߛਦ֧ీ૰ ዊଉԍኤჱ໿൶ጺ॔ Mark J. GOLDBERGER ᅅბձ๗ˈࠅࠌ࿐ิຬ๗ض߬ન໎๏ਖ਼዆ᄱඇ൰ዊଉᇑ݆ࡀଣ മெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ᄱ೗อೠ຺ևև׊ ၃࠶૙ ெࡔ)'$ཞඦࣷׯᇵޅዊଉڦ๬ᄓضଣ Beat E. WIDLERձ๗ ெࡔჯಢ዆ᄱ݆ࡀአ֧ޭጺ֋ ෌๗:LGOHU 6FKLHPDQQࠅິࢇअට փཞᅪ९ڦ૙ਦ֧ዐतਦ֧ࢫتெࡔ)'$සࢆ Robert J. MEYERᅅბձ๗ ٴ၄ׇ༵࿚ᇑ঴ മெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐อೠܾևև׊ ெࡔ)'$ཞඦࣷׯᇵ ݴׇܾࣷ_݆ࡀ๚ခ ெࡔఐਖ਼ࠅິǄఐ෭۫ǅඇ൰ጀ֩቟୼Ă݆ࡀአ֧तᄱ೗Ҿඇޭጺ֋

ጆॆ༪ஃ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ᅜฉ঄ኁᅜतසူጆॆǖ ෙ֫ǈࣜࢋཐǅ ྦྷ༢ᅅბձ๗ ૙և׊پอೠܾևض࠶૙ਆᄱ೗อೠዐ႐ଣ۽ዐࡔࡔॆ๋೗ᄱ೗॔ CDEᄱ೗ጧკࣷঢ়ᄓݴၛ ૚ౢᅅბձ๗ ࣷᅱዷ׼ ෘ౷ݤඇ൰ᄱአޭጺ֋ǈჱዞ൶ᅅბአ֧ዷ࠶ David RUSSELL ૚ౢᅅბձ๗ ෘ౷ݤඇ൰ᄱአޭጺ֋ǈჱዞ൶ᅅბአ֧ዷ࠶ ฉ࡛෗ܻएᅺ዆ᄱጺঢ়૙

౎ሆ݀քକĖႎᄱጀ֩༬๺อ಼࠶૙ࡀۨėǈኄ๟6)'$ ݴׇࣷ777_౎ሆනˈ႓೺ܾዐࡔ6)'$ᇀ ೿֫ǈฉ࡛ཐǅ ă܈ኟ๕ጧკ዆ڦԘኮᅃă޿݆ࡀॺ૬କዐࡔႎᄱอೠዐײ૛ڦݥ׉ዘᄲ ࠶૙ਆᄱ೗อೠዐ႐߾ፕ࣮ࠥᇑቛྭ۽߳঩ ዐࡔࡔॆ๋೗ᄱ೗॔ڦăฤӸኁీࠕሞႎᄱਸ݀ڢࠏཚർڦႎᄱჺ݀ኁ༵ࠃକ߸ेཪ௽ྺ ڟڥਆ৽੔ბ࿚༶৊ႜ༪ஃǈٗዐړጧკࣷᅱǈᇑ॔࠶ڦ܎ฤ൩ቻਸኟ๕ ጧკࣷᅱăሞԨጆׇڦब౎ዐǈ&'(ᅙঢ়ቻਸକຕْኟ๕ڦăࡗඁڞኸ ঄ኁ x &'(ኝ༹঻ถڦ࣮ࠥઠጲ዆ᄱႜᄽڦጀ֩࣍ৣ৊ႜᅃ߲०ᄲڦዐࡔܔዐǈ5'3$&ॽ ӄ૩ࢅঢ়ᄓă x &'(อೠਦ֧ୟ০ڦᄺॽݴၛසࢆᇑอೠዐ႐Ҿಇኟ๕ጧკࣷᅱ ᇱሶ༹ဣڞx &'(ᄱ೗อೠኸ ණኪڦዐࡔᄱ೗॔࠶࣍ৣܔ&3$'5 ࿚༶ۅჺ৯ඤضx &'(ଣ ׉ॺ൞ ၃੦዆ޅڦضႎᄱଣظ)'& x ዐࡔྔฆཨጨഓᄽၹࣷᄱ೗ჺ዆ࢅਸ݀ႜᄽ྿ᇵࣷǄ5'3$&ǅᄱአࢅᅅბ ๚ခጺ॔ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ײүਖ਼༺౅ๆ౎ჺ݀૦ ೿֫ǈฉ࡛ཐǅ ྦྷᆇၗձ๗ ࠶૙ਆᄱ೗อೠዐ႐߾ፕ࣮ࠥᇑቛྭ۽ᄱᄽᆶ၌ࠅິࠅິጺ֋ǈ๯ဝ੔ბॆ ዐࡔࡔॆ๋೗ᄱ೗॔ٳኅॿԞ

૩ݴၛ x &'(ኝ༹঻ถํڦᄱอዐ႐ႎᄱ35(,1'ጧკࣷ ੪ඥࢾ x &'(อೠਦ֧ୟ০ ᇱሶ༹ဣڞҮຯ૧੃Ǆዐࡔǅᄱአࢅᅅბ๚ခߛपঢ়૙ x &'(ᄱ೗อೠኸ ࿚༶ۅჺ৯ඤضx &'(ଣ ၃੦዆ޅڦضႎᄱଣظ)'& ݴׇࣷ7_౎ሆනˈ႓೺ܾ x ෙ֫ǈࣜࢋཐǅ ੔ბਦ֧üü๟૙ၙ࣏๟၄ํ˛ ݴׇࣷ7_౎ሆනˈ႓೺ෙڦ$'(ெࡔ ෙ֫ǈࣜࢋཐǅ ࣷᅱዷ׼ ࡀᄲ൱ࢅํ७݆ڦᅅଐഗႁतᄱ೗ഗႁፇࢇׂ೗ ૚ጲ૰ᅅბձ๗ˈࠅࠌ࿐ิຬ๗ อೠፇፇ׊ضമெࡔ)'$ႎᄱଣ ࣷᅱዷ׼ ெࡔ)'$ཞඦࣷࡔाև૴ဝዷဝ ெࡔఐਖ਼ࠅິǄఐ෭۫ǅႎ႗๨ׇጀ֧֩୼ኴႜጺ॔ Jeffrey R. FERGUSON ૝ઠ዆ᄱඇ൰݆ࡀ๚ခǄ&0&ǅጺ॔ ॆٷᅃْᇑڼߛप࠳ᇵڦෙ࿋മெࡔ)'$ᄱ೗อೠჺ৯ዐ႐ڟࣷኁॽࣷད֖ ࠶ݴૌĂጀ֩Ăዊଉ੦዆॔ڦබࢇକ໱ Ԩጆׇॽ঻ถᅅଐഗႁतᄱ೗ഗႁፇࢇׂ೗ۅ࠵ڦ཈቟ăෙ࿋঄ኁڦݴၛ໱்߲ටሞड़వ॔࠶ਦ֧ዐ໯ঢ়૦ࡗ ፌႎ৊ቛăཞ้ǈᅜํ૩঻ถፇࢇׂ೗ਸ݀ڦԐࡍঢ়૦ăໜጣ੔ ᅜतᅅଐഗႁฉ๨಼ጚമࡀۨڦჺ݀ኁڦሼঢ়ፕྺአު॔࠶ኁᅜतࢫઠٗ๚ᅅᄱׂᄽ் ཈቟ࢅऐᇜăڦዐ໯௬ଣ ܔ$'(཈቟ᄺᇑනਓኋă৑࠶ڦቛන൵ްሗǈெࡔ)'$௬ଣጣ݀ڦბࢅมࣷ ॔ܔඪခઠ஌ํǈ዆ᄱᄽۅፕᅃၜዘړᄲ൱փ܏ሺेǈժڦ܈ߛԨวཪ௽༵ Ⴞײ၃ࢅ૧ᅮೠࠚतਦ ዐࡔᅅଐഗႁ॔࠶઀ॐࢅጀ֩ޅ׉׉փ໿କ঴ǈփኪ॔࠶ևோසࢆ৊ႜᄱ࿿݆ၙڦ࠶ኁ ਆ ྦྷᇔࢤړ࠶॔ڦഄ໲ࡔॆܔᄱ࿿੔ბอೠᇱሶǈኄڦ$'(ăԨጆׇॽ঻ถெࡔ֧ ૰ዐࡔᆶ၌ࠅິአ֧݆ࡀևአ֧݆ࡀ๚ခጺ॔ܘᄺᆶ঺६ፕᆩă ெࡔெ

࠶૙ਆ঄ኁᅙᄥ൩۽ெࡔ)'$੔ბਦ֧௬௬࠵ ዐࡔࡔॆ๋೗ᄱ೗॔ Florence HOUNᅅბձ๗ˈࠅࠌ࿐ิຬ๗ ፌႎ݀ቛڦമெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ᄱ೗อೠෙևև׊ ெࡔ)'$࠲ᇀᄱ೗ഗႁፇࢇׂ೗॔࠶ ெࡔ)'$ཞඦࣷࡔाև૴ဝዷဝ Scott DANZIS

Ӥଳୱ฾๚ခ໯๋೗ᄱ೗त࿐ิԍॳևࢇअට ݴׇࣷ_౎ሆනˈ႓೺ෙܙ੔࿔ ෙ֫ǈࣜࢋཐǅ ᄱ೗ഗႁፇࢇׂ೗ǖഓᄽӄ૩ჺ৯ ݠ዆ᄱ ॔࠶཈቟ࢅऐᇜ Jeffrey R. FERGUSON üü ૝ઠ዆ᄱඇ൰݆ࡀ๚ခǄ&0&ǅጺ॔ ࣷᅱዷ׼ ณᇖ݆ბձ๗ר Ӥଳୱ฾๚ခ໯ߛपࠥ࿚ǈዐࡔ๋೗ᇑᄱ೗݆ୱ޶ሴටܙݴׇࣷ7_౎ሆනˈ႓೺ෙ ੔࿔ ෙ֫ǈࣜࢋཐǅ Ԓߢǈ޿౎ࠌᆶ߲ᄱ೗ฤ൩ǈഄዐᆶ܈ߵ਍6)'$ᄱ೗ጀ֩౎౎ ǈݠੂ܈ߵ਍ణമঢ়ष݀ቛࢅႜᄽጒ઄ǈٗ׊ᇺঙڍ၄ጒᇑৃࢫ݀ቛݛၠ ߲๟ݠ዆ᄱฤ൩ăڦ$'නԨ30 ᄱ೗ጀ֩ዐ቞ᆶ࢔ዘԲ૩ăԨጆׇᆯઠጲࡔాࢅੵࡔڦ዆ᄱฤ൩ධॽሞዐࡔ ӄ૩ࢅঢ়ᄓǈᅜतৃڦ঄ኁᇑདዚݴၛሞዐࡔ৊ႜݠ዆ᄱฤ൩ጀ֩ڦࣷᅱዷ׼ǖ ࠅິ ཈቟ࢅऐᇜăڦ޷ᆦਯ義 ձ๗ ࢫब౎໯௬ଣ නԨᅅᄱ೗तᅅଐഗႁ࠶૙ऐࠓࡔा๚ခևዷඪ ੊ॏኵ֖ڦ܈ዐࡔࢅᆇܔୱ݆ࡀᄲ൱तഄ݆ڦெࡔ)'$ݠ዆ᄱอ಼ ณᇖ݆ბձ๗ר ᅃၜ཈ڦਆړമ߳ࡔᄱ೗॔࠶ړጚᄱ೗ฉ๨ᅜ஢ፁթටᆩᄱႴ൱๟಼ں৑੺ Ӥଳୱ฾๚ခ໯ߛपࠥ࿚ǈዐࡔ๋೗ᇑᄱ೗݆ୱ޶ሴටܙ቟ăԨጆׇॽᆯනԨᄱ೗ᅅଐഗႁਆ न30'$঻ถഄႎᄱฤ൩Ǆ1'$ǅอ ੔࿔ ăԨጆׇᄺҾಇକӄ૩ჺ৯ǈٗ዆ڞೠ߾ፕᅜतසࢆྺႎᄱਸ༵݀ࠃጧკኸ ȍȍݠ዆ᄱਸ݀ጀ֩ႎາ੊ظፕᆩă ݠዐᆶڦ໯ഐײሞႎᄱਸ݀ࡗڞጧკኸڦ$'ೠॏ30܈ঙڦᄱഓᄽ Ⴙၠᄞձ๗ ำჺ৯ᇾޭᇾ׊ǈݠ዆ᄱਸ݀޶ሴටံ ܈ഽႎᄱอ಼ĊĊे੺อ಼໏े$'30 ᅈགྷ紀ᄏᅅბձ๗ ႎऐᇜڦ዆ᄱࠅິ܈ݠ዆ᄱȍȍᆇڦනԨᅅᄱ೗तᅅଐഗႁ࠶૙ऐࠓႎᄱෙևև׊ ᅙ಼ጚ Udupa N.ঞ๲ ბᄱბᇾᄱݝ࠶૙ဣٷ0DQLSDO܈ೠॏ ᆇڦጧკतׯࠀఇ๕ĊĊჺ݀ኁ$'30 עߛᄸቾ Ҿຯ໽ઠ዆ᄱࠅິǄනԨǅඇ൰݀ቛևჱዞਸ݀቟୼ߛपጺ॔ ݴׇࣷෙ_&0&*03 ڞኸڦჺ৯ਸ݀቟୼ܔ׶౷ĊĊڦኧ׼മᄂरຍ$'30 Ҿ༭剛 ձ๗ නԨᅅᄱ೗तᅅଐഗႁ࠶૙ऐࠓอೠ࠶૙ևᄱ೗ჺ݀቟୼ᄱ๚ጧკፇޭፇ׊ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ෙ֫ǈ&'ǅ

ݴׇࣷ_౎ሆනˈ႓೺ෙ &0&ݛ୼तํ७ ෙ֫ǈࣜࢋཐǅ ࣷᅱዷ׼ ኪ๎ׂ඄ԍࢺ ඪᅫձ๗ڦႎᄱਸ݀ዐ ஆ๧ჺ݀Ǆዐࡔǅᆶ၌ࠅິᄱბևߛपጺ॔ ࣷᅱዷ׼ ቧᄏ༢ձ๗ ณᇖ݆ბձ๗ ૝ઠ዆ᄱඇ൰ࢇፕჺ݀ჱ໿൶ޭጺ֋ר ੔࿔ܙӤଳୱ฾๚ခ໯ߛपࠥ࿚ǈዐࡔ๋೗ᇑᄱ೗݆ୱ޶ሴට ڦภत&0&ăඓۨኟඓۼ๟ᄱ೗ਸ݀ዘᄲፇׯևݴǈႎᄱᇑݠ዆ᄱ&0& ጚǈԍኤᄱ೗ሞิ಼ڦᄱ೗ฉ๨ܔ࠶ևோ॔ڥ࠲॰ᄲ໎ăৎ౎ઠǈዐࡔሞኪ๎ &0&֧୼ॽփৈీࠕे੺इڦኪ๎ׂ඄ԍࢺ๟ඪࢆׯࠀႎᄱਸ݀ၜణዐ ׯԨၳڦፌࡻڥߛዊଉࢅ਩ᅃႠǈܸ൐๑ᄱ೗ਸ݀ኁइڦዐײ࿚༶ࢅ཈቟ă ׂࢅၨ๳ࡗڦᄺ௬ଣᅃၵႴᄲ঴ਦڍକ׼Ⴤ࿘ۨ৊օǈڥ඄ԍࢺݛ௬ൽׂ ࠲॰ևݴăڦጆ૧ࢅഄ໱ኪ๎ׂ඄ԍࢺ၎࠲݆ ᅮăԨጆׇॽᆯ዆ᄱഓᄽࢅ॔࠶ևோݴ՚঻ถ&0&֧୼ڦሞُْၭፇࣷᅱዐǈᇑࣷጆॆॽ༪ஃዐࡔ ዐኪۯঢ়ᄓǈժ঻ถሞႎᄱਸ݀ऄڦༀǈݴၛሞਏ༹ํ७߾ፕዐۯፌႎڦୱ ࿚༶ă &0&ݛ୼ࢅඇ൰ࢇፕڦ඄ԍࢺႴᄲՆ௨ׂ๎ ৑ኰ߾ፕ Scott COFFEYڦዐኪ๎ׂ඄ԍࢺײႎᄱฤ൩๲඄Ⴙ੗ࡗظ ெࡔ૝ઠࠅິ߾ᅝยऺࢅਸ݀ևঢ়૙ ฬॺዐ݆ბձ๗ Үຯ૧੃Ǆዐࡔǅ݆ခև݆ୱࠥ࿚ ༚໋ࡪᄱბձ๗ ႎᄱਸ݀ᆶ၌ࠅິิׂጺ֋ڤ࿮ဍᄱ௽੃ ፌႎ৊ቛڦዐࡔᄱ೗ኪ๎ׂ඄ԍࢺ ࡀݛ୼݆ڦ&ቧൣઊ݆ბձ๗ &0 ᢣڭ ዐࡔࡔॆኪ๎ׂ඄ਆᅅᄱิ࿿อֱև ฉ࡛ஆ๧዆ᄱᆶ၌ࠅິጀ֩ጺ॔ ୼ঢ়ᄓݴၛ्֧ٶዐࡔ ஆኟࢤ݆ბձ๗ ஆমୱ฾๚ခ໯ࢇअට ݴׇࣷ7_౎ሆනˈ႓೺ܾ ෙ֫ǈ&'ǅ ፏთᇑዊଉڦጆॆ༪ஃ &0&ݛ୼ࢅํ७üü*03 ഄ໱ጆॆ ࣷᅱዷ׼ ץᄘ ࢇअට ඪᅫձ๗تࡔाୱ฾๚ခ໯ԛ৙Ӹ๚ڤฺ ዐࡔิం੔ბᄽခ޶ሴට ஆ๧ჺ݀Ǆዐࡔǅᆶ၌ࠅິᄱბևߛपጺ॔ڤฺ ૚ྸํձ๗ ቧᄏ༢ձ๗ ࢠ᱌ୱ฾๚ခ໯ฉ࡛Ӹࠅ๪ࢇअට ૝ઠ዆ᄱඇ൰ࢇፕჺ݀ჱ໿൶ޭጺ֋

ፏთ ඪᅫձ๗ڦዐࡔ*03 Steven WOLFGANG ձ๗ ஆ๧ჺ݀Ǆዐࡔǅᆶ၌ࠅິᄱბևߛपጺ॔ ૙ޭևپெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ᄱ೗Ҿඇྜኝतቻ࣮ևᇑํแኴႜև ׊ Ԉጎ੊୯ǄՔധĂጎሏĂݴ݀Ă࿿ୁǅ Mark PLEZIA แᇑ၄ጒ ெࡔഽิ0F1HLOॳ੃ၩݯࠅິ዆ᄱԈጎरຍჺ݀ޭጺ॔ํڦࡔॆዐٳ03ሞ݀ቛዐࡔॆᇑ݀* ຬ๗ˈ߾ฆ࠶૙ຬ๗ײࣅბ߾ރीૃ ݛӄ֧୼ڦฉ࡛ҾՂิ዆ᄱरຍᆶ၌ࠅິ๯ဝኴႜ࠳ ࿘ۨႠ๬ᄓ ්ዒ๗ձ๗ ጆॆ༪ஃ ெࡔӥ้ெแࡍԐݴဆჺ݀ևޭጺ॔

रຍࢅݛ݆ᆅ෇ ݴׇࣷ777_౎ሆනˈ႓೺ܾ KIM Huynh-Ba ዷඪڞಢჟኸۆ྿ᇵࣷᄱۆ೿֫ǈฉ࡛ཐǅ ெࡔᄱ ࠶૙ਆᄱ೗อೠዐ႐߾ፕ࣮ࠥᇑቛྭ۽ዐࡔࡔॆ๋೗ᄱ೗॔ ጆॆ༪ஃ x &'(ኝ༹঻ถ x &'(อೠਦ֧ୟ০ ݴׇࣷ7_౎ሆනˈ႓೺ෙ ෙ֫ǈ&'ǅ ᇱሶ༹ဣڞx &'(ᄱ೗อೠኸ แํڦᇱሶڞतഄ໲ዊଉኸڦ࿚༶ ,&+ႎۅჺ৯ඤضx &'(ଣ ၃੦዆ޅڦضႎᄱଣظ)'& x ࣷᅱዷ׼ ᤷ᤼ձ๗ר ݴׇࣷ7_౎ሆනˈ႓೺ܾ ࣪෌ඇ൰&0&ኴႜጺ॔ อೠዊଉೠࠚևޭև׊ض೿֫ǈฉ࡛ཐǅ മெࡔ)'$ႎᄱଣ ࠶૙ਆᄱ೗อೠዐ႐߾ፕ࣮ࠥᇑቛྭ ெࡔ)'$ཞඦࣷࡔाևׯᇵ۽ዐࡔࡔॆ๋೗ᄱ೗॔ 4ǈĖᇱଙᄱਸ݀ᇑิׂėǈ๟,&+एᇀዊଉᇸᇀยऺǄ4E'ǅࢅׂ +&, ᅃ߲ăԨጆׇॽ঻ถ๢ڦᇱሶዐፌႎڞᅃဣଚዊଉኸڦx &'(ኝ༹঻ถ ೗ิంዜ೺૙౒዆ۨ ᇱሶĖิ࿿ڞ4ăُྔǈ࣏঻ถ,&+ 4(ኸڦx &'(อೠਦ֧ୟ০ ᆩᇀࣅბᄱࢅิ࿿रຍׂ೗ ኸ+&,ܔ੗ԲႠėǈժᆶӄ૩ݴဆăፌࢫॽۯᇱሶ༹ဣ रຍׂ೗ิ࿿዆೗ิׂ߾ᅝՎڞx &'(ᄱ೗อೠኸ Ԉྷᇑਈን๕ยऺėǈࢅ4(ǈĖ࿘ۨႠຕ਍ڦᇱሶ4'ǈĖ࿘ۨႠ๬ᄓڞ ࿚༶ۅჺ৯ඤضx &'(ଣ ੔ბ੊୯ᅜतഄํแ৊ႜ঻ถăڦೠॏėǈ ၃੦዆ޅڦضႎᄱଣظ)'& x ᇱሶ4ǖĖᇱଙᄱਸ݀ᇑิׂėڞኸ+&,ڦႎ Patrick SWANN ݴׇࣷ7_౎ሆනˈ႓೺ෙ ձ๗ ெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ิ࿿रຍׂ೗ևޭև׊ ՗پෙ֫ǈ&'ǅ ெࡔ)'$,&+4ጆॆ߾ፕፇ &0&ڦᄱ೗዆व ੗ԲႠėǈतഄํۯᇱሶ4(ǈĖิ࿿रຍׂ೗ิ࿿዆೗ิׂ߾ᅝՎڞኸ+&, ࣷᅱዷ׼ แ ᄾଫձ๗ ࿲ᵬࠁձ๗ ׊تݛᄱჺ݀ݴဆჺ݀ޭጺ॔ ݆ஒ༬ጧკጧკևጨศتฉ࡛ഽิ዆ᄱᆶ၌ࠅິჱ໿൶ݥ อೠዊଉೠࠚևޭև׊ضඪᅫձ๗ മெࡔ)'$ႎᄱଣ ՗پஆ๧ჺ݀Ǆዐࡔǅᆶ၌ࠅິᄱბևߛपጺ॔ മெࡔ)'$,&+4(ጆॆ߾ፕፇ

ፌڟਸ݀ڦݛتแ࿚༶ǈٗ዆वದݛํڦԨጆׇᆶኪఁጆॆ༪ஃ&0&ݛ୼ փཞ ݴׇࣷ7_౎ሆනˈ႓೺ෙڦरຍǈᆩᇀᄱ೗዆वਸ݀ڦࢫ዆व࿘ۨႠ๬ᄓăࣷᅱ֨ዘᇀ༵ࠃํᆩ ෙ֫ǈ&'ǅ ࿚༶ăڦ঄ᄇዐٴ঩܎ă໯ᆶ঄ᄇ঳ຐኮࢫǈԨጆׇॽҾಇጆॆ༪ஃժ঴ แํڦᇱሶڞतഄ໲ዊଉኸڦႎ+&, ၳႠڪࢅิ࿿܈࿿૧ᆩิ Dale CONNERձ๗ ࣷᅱዷ׼ ᤷ᤼ձ๗ר ׊تتၳႠೠॏᅃڪெࡔ)'$ᄱ೗อೠዐ႐ݠ዆ᄱևิ࿿ ࣪෌ඇ൰&0&ኴႜጺ॔ อೠዊଉೠࠚևޭև׊ض዆वದݛਸ݀ മெࡔ)'$ႎᄱଣڦݠ዆ᄱ ձ๗ ெࡔ)'$ཞඦࣷࡔाևׯᇵחᄾ ݛᄱჺ݀ޭጺ॔تഽิჱ໿൶ݥ Ԉྷᇑਈን๕ยऺėǈࢅ4(ǈĖ࿘ۨڦᇱሶ4'ǈĖ࿘ۨႠ๬ᄓڞኸ+&, Ⴀຕ਍ೠॏėǈतഄํแ ݴׇࣷ7_౎ሆනˈ႓೺ෙ ଠሶඇձ๗ ෙ֫ǈ&'ǅ ิ࿿ᅅᄱጧკࠅິጨศࠥ࿚ ૙ޭև׊پอೠዊଉೠࠚևضമெࡔ)'$ႎᄱଣ &0&ڦᄱ೗዆व മெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐࿘ۨႠरຍ྿ᇵࣷዷဝ ࣷᅱዷ׼ )'$ᄱ೗อೠᇑჺ৯ዐ႐ิ࿿዆೗๬ႜऺࣄ ᄾଫձ๗ Patrick SWANNձ๗ ݛᄱჺ݀ݴဆჺ݀ޭጺ॔تฉ࡛ഽิ዆ᄱᆶ၌ࠅິჱ໿൶ݥ ெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ิ࿿रຍׂ೗ևޭև׊

׊تޭتᆌยऺ ጆॆ༪ஃ ቧၬࣀձ๗ ჱ໿൶ᅅᄱራ೺ჺ݀ཥऺბ޶ሴට ఐਖ਼ჺ৯ᇾჱ໿൶ิ࿿ཥऺࢅჺ৯ਦ֧੔ბև ݴ຺ׇࣷ_ཥऺ ڦᄱ೗ჺ৯ਸ݀ዐࣩ݀ጣዘᄲፕᆩǈഄዐԈઔྲݴဆپߛཚଉิ࿿रຍሞ၄ ࿿ኸิܔፌႎ৊ቛăኍڦएᅺಇႾپ෢௮Ăᅜतႎᅃڦ঳ࡕĂएᅺݛ௬ٳ՗ ڦӣǈாࢅࢃ໗ݴጱლቴ݀၄ᆶଐၳڒߛཚଉरຍీࠕ๑዆ᄱࠅິཚࡗڦݴׇࣷ7_౎ሆනˈ႓೺ܾ Ք ӣዊፇბ༬Ⴀࢅթටदթ၎࠲ईኁፕྺᄱڒ࿵֫ǈ׊ॿཐǅ ࣅࢇ࿿ǈኄၵࣅࢇ࿿ཚࡗएᅺई ࢅ੔ბჺ৯ኁǈ঻ถิضଣڦ࿿ăԨጆׇॽᆯઠጲ੔ჺࢅ዆ᄱႜᄽڦӜڦ೗ ᆌᆩăڦቛᅜतሞᄱ೗ჺ৯ਸ݀ዐ݀ڦ๬ᄓኸళतຩᆌยऺኸళ ࿿ኸՔߛཚଉݛ݆ضݥଝၳႠଣ

ࣷᅱዷ׼ ֪Ⴞǈ֪Ⴞǈ֪Ⴞ ྦྷ࿴ԍձ๗ ࠋጝଟձ๗ एᅺჺ৯ᇾᄱ࿿एᅺፇბև޶ሴටٷெࡔఐਖ਼ࠅິఐਖ਼ჺ৯ํᄓ๪ิ࿿ཥऺᇑჺ৯ਦ֧੔ბևჱ໿൶ጺ॔ ศᒰࣀ ᇰྼᆗձ๗ एᅺፇ51$߅ඡჺ৯ڦႾևோጺ॔ ᄱ࿿ჺ݀ዐײഽิᄱ࿿ჺ݀ዐࡔิ࿿ཥऺࢅཥऺ ቧၬࣀձ๗ ᆶ࠲ӄ ჱ໿൶ᅅᄱራ೺ჺ݀ཥऺბ޶ሴටڦ๬ᄓض߸ႎǈᄺॽݴဆݥଝၳႠଣڦԨጆׇݴࣷॽ঻ถ޿ኸళ֥ӄ ঳ ఐਖ਼ჺ৯ᇾჱ໿൶ิ࿿ཥऺࢅჺ৯ਦ֧੔ბևֱۙڦፔ݆ǈঢ়ᄓतઓవڦ๬ᄓضഓᄽ๑ᆩຩᆌยऺ৊ႜଣܔ૩ăଷྔǈ ࡕᄺॽሞࣷฉ৊ႜ঻ถă঄ᄇኮࢫǈॽᆶ॔࠶݆ࡀຫ௽ᅜतጆॆ༪ஃǈԈઔ ႇፇბپӣዊፇბᇑڒڦ࿚༶ă ๢ᆩᇀิ࿿ኸՔ݀၄ᇑᄱ࿿ਸ݀ڦݥଝၳႠࢅຩᆌยऺݛ௬ Toshiyuki MIKAMI ৊ቛ ձ๗ڦᇱሶ֥ӄڞݥଝၳႠኸ ႇፇბጆॆپӣዊፇბࢅڒනԨዿᆷ዆ᄱएᅺፇ੔ბํᄓ๪ H. M. James HUNGձ๗ ׊تتெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ิ࿿ཥऺ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ཥऺბ੊୯ڦ๬ᄓዐݥଝၳႠยऺضଣ ೿֫ǈฉ࡛ཐǅ ဲ঳ઠঞ๲ ࠶૙ਆᄱ೗อೠዐ႐߾ፕ࣮ࠥᇑቛྭ۽࠶૙ਆᄱ೗อೠዐ႐ཥऺბྔևอೠ ዐࡔࡔॆ๋೗ᄱ೗॔۽ბǈዐࡔࡔॆ๋೗ᄱ೗॔ٷ຺ਬᅅڼ ጆॆ x &'(ኝ༹঻ถ x &'(อೠਦ֧ୟ০ ֱۙڦ࠲ᇀຩᆌยऺ$,' ᇱሶ༹ဣڞNitin PATELձ๗ x &'(ᄱ೗อೠኸ ெࡔ&\WHOࠅິዷဝग़๯ဝरຍ࠳ ࿚༶ۅჺ৯ඤضx &'(ଣ ၃੦዆ޅڦضႎᄱଣظ)'& x ݴׇࣷ7_౎ሆනˈ႓೺ܾ ࿵֫ǈ׊ॿཐǅ ݴׇࣷ7_౎ሆනˈ႓೺ෙ ࿵֫ǈ׊ॿཐǅ ๬ᄓኸళतຩᆌยऺኸళضݥଝၳႠଣ

ยऺࢅݴဆڦ߁౒ᄓኤࢅवଉඓۨ๬ᄓڦࣷᅱዷ׼ ႎᄱਸ݀ዐ

࿴ԍձ๗ ࣷᅱዷ׼ྦྷ ெࡔఐਖ਼ࠅິఐਖ਼ჺ৯ํᄓ๪ิ࿿ཥऺᇑჺ৯ਦ֧੔ბևჱ໿൶ጺ॔ ൸ಶձ๗ ᇰྼᆗձ๗ ࣪෌Ǆዐࡔǅჺ৯ਸ݀ᆶ၌ࠅິཥऺևߛपጺ॔ Ⴞևோጺ॔ײഽิᄱ࿿ჺ݀ዐࡔิ࿿ཥऺࢅཥऺ ஆኒձ๗ ೠॏ ࣪෌Ǆዐࡔǅჺ৯ਸ݀ᆶ၌ࠅິཥऺևጺ॔ڦຩᆌยऺֱۙ$,'ܔ Sue-Jane WANG ձ๗ ๬ᄓ჋ൽ๴๬ݛضࢫ೺ଣྺںăᆶၳጚඓײࡗڦਸ݀๟ᅃၜӆࡍࢅ஦׊ضெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ገࣅᅅბևǈิ࿿ཥऺևᄱ࿿एᅺፇბᇑຩᆌ ଣ ࢅ߸ڦઠႎټ࣒ኁྺںዘᄲᅺ໎ǈཞ้ᄺ੗ᅜ৑ራڦਸ݀ׯࠀض׊ ӄ๟ԍኤଣتޭتยऺ ೺܈ߛڦႎᄱܔփ܏ฉืࢅڦዎଐݛӄǈഄዘᄲႠໜጣႎᄱჺ݀ݯᆩڦᆶၳ ߸े၂ዸăڥՎྭ ጆॆ༪ஃ ๬ᄓضยऺࢅݴဆǈᅜतྺࢫ೺ଣڦჺ৯঩܎ضᅜฉ঄ኁत༬ᄥጆॆǖ Ԩጆׇॽጣዘᇀ༑༪ራ೺ଣ ݛ݆ăڦएᇀఇ႙ెࢇڦඓۨवଉ ࣜਖ਼౹ձ๗ ๬ᄓยऺضଣڦெࡔ,59,1*&2168/7,1**5283Ǆ,&*ǅཥऺጧკࠥ࿚ࠅິጺ֋ ߁౒ᄓኤࢅवଉ༑໭၎঳ࢇ ձ๗ڱ迺ۡ ࠶૙ਆ঄ኁᅙᄥ൩ ெࡔղଠ߭ᅻ߭ࡪ዆ᄱิ࿿ཥऺბጨศཥऺ฾۽ዐࡔࡔॆ๋೗ᄱ೗॔

ݴဆڦवଉ჋ൽ——ᅃ߲ํाӄ૩ڦएᇀዐ೺ݴဆ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ឌհձ๗ˈ߾ฆ࠶૙ຬ๗ ൶ิ࿿ཥऺևጺ॔ںᅅᄱჺ৯ਸ݀Ǆฉ࡛ǅᆶ၌ࠅິჱ໿ۦ࿵֫ǈ׊ॿཐǅ ৛ ᄱ೗ჺ৯ਸ݀ۨଉߛཚଉิ࿿ኸՔෲ჋݀ቛ ᆌᆩڦᄓยऺዐํضॺఇࢅఇెሞଣ ࣷᅱዷ׼ ႇ඿ूձ๗ ࢅۨଉᄱ૙ბޭጺ॔ضSue-Jane WANGձ๗ ࣪෌Ǆዐࡔǅჺ৯ਸ݀ᆶ၌ࠅິଣ ெࡔ)'$ᄱ೗อೠᇑჺ৯ዐ႐ገࣅᅅბևǈतิ࿿ཥऺևᄱ࿿एᅺፇბᇑຩ

K. Arnold CHAN ձ๗ ٴ၄ׇ༵࿚ᇑ঴ ெࡔ2SWXP,QVLJKWࠅິิం੔ბୁႜթბ๯ဝ੔ბॆ ბࠅࠌ࿐ิბᇾୁႜթბဣ๯ဝୁႜթბॆٷގெࡔࡘ ݴׇࣷ࿵_ᄱ࿿Ҿඇ ᅱ঻ถۯ౹௑႑ࡽॠ֪ኸళᅜत(0$ Martin VOTAVAᅅბձ๗ ݴׇࣷ7_౎ሆනˈ႓೺ܾ যਖ਼3KDUP,QYHQWࠅິ݆ࡀ੔ბጺ॔ ࿵֫ǈ'(ǅ ᇱ౹௑ᄱ೗ਆටᆩᄱอೠ྿ᇵࣷׯᇵ ˅ᄱ࿿য়শԒߢ˄39ڦतฉ๨Ⴙ੗้໯׶౷ڦჺ݀ኁᆌ৊ႜ

ቛ݀ڦࣷᅱዷ׼ ݴׇࣷୃ_&52 ଠ٘ ࣪෌Ǆዐࡔǅჺ৯ਸ݀ᆶ၌ࠅິඇ൰Ҿඇࢅᄱ࿿ጀ֩ሏᆐևǈᄱ࿿Ҿඇೠॏ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ࢅԒߢǈெࡔᄱ࿿Ҿඇևோጺ॔त޶ሴට ࿵֫ǈ%&ǅ ቛ݀ڦࢇፕअӵ࠲ဣሞඇ൰዆ᄱࠅິኮ &52ሞዐࡔڦৎ౎ઠǈࠌཞჺ݀ᄱ೗ᅜत૴ࢇฉ๨ၨ๳ ࢇڦक़ሁ݀׉९ժ൐න൵ްሗăዐࡔ๨ׇฉᄺփ܏؜၄ੵࡔᄱഓࢅԨཱིഓᄽ ၃ೠࠚǈሞധຈࢇፕၹᅱኮമǈࢇፕݛ ࣷᅱዷ׼ޅڦࢇፕᆶᅃ߲ጹࢇඇ௬ܔፕăྺକ ă Թࢤߒձ๗ڦඇ௬ೠॏ๟ݥ׉ዘᄲڦᄱ࿿য়শဣཥڦݛܔҾඇႠᅜतڦ໯ภतᄱ೗ܔ ჹ߭॔࠶࣍ৣူǈࢇፕݛᄺՂႷྜඇኪၬժ൐ፏთඇ ੔࿔ຯඇ൰ޭጺ֋ǈዐࡔ൶ጺঢ়૙ڦᄱ࿿য়শتཞ้ǈว ᄱ࿿য়শ݆ࡀăڦᄲ൱त၎ᆌ܈዆ڦᄱ࿿ҾඇԒߢܔ൰߳ᄱ॔ऐࠓ ࠆჼࣀ ǈժॽ݆ٗୱत߳ࡔ॔࠶ևோ ඇࡔᅅᄱ๨ׇၹࣷޭ૙๚׊ǈඇࡔᅅᄱरຍ๨ׇၹࣷ&52૴ࢇ༹ޭዷဝग़௞ײఇ๕ࢅࡗڦԨጆׇॽ঻ถᄱ࿿য়শ৑ኰֱۙ ႎࢅጆᄽࣅ྿ᇵࣷ׉ခޭዷඪظ঻ถᄱ࿿য়শ႑တၹᅱă ກ׊ǈႎᄱ܈ঙڦࡀ݆

ऐࠓࠅິǈڦܠփ܏ሺڟୱࢅ॔࠶ᄲ൱ ዐࡔࢇཞჺ৯ႜᄽǈन&52ႜᄽሞ݀ቛǈ੗ᅜੂ݆ڦᄱ࿿য়শၹۨܔኍ ට֍ٗ๚ࢇཞჺ৯ǈओેକჺ৯ၜణڦਏᆶߛዊଉጆᄽ຤ጚڦຕଉړMaria Grazia ZURLO ձ๗ ᅜत၎ փڦቛǈᅜत዆ᄱׂᄽ݀ڦঢ়ᄓăࡔాࢅࡔा&52ሞዐࡔڦ૧ǅޭጺ֋ǈ౹௑ᄱ࿿য়শጆᇵ ํแࢅዊଉԍኤٷ࣪෌Ǆᅪ ԍኤăڦׯຄ๟ዐࡔᄱ࿿ਸ݀ׯࠀ܏ ቛ൵๞ǖ݀ڦᄱ࿿য়শဣཥ Ԩጆׇॽ༪ஃዐࡔࡔాࢅඇ൰&52ڟႾǖٗᄱ೗ҾඇႠײڦᄱ࿿য়শ৑ኰֱۙ ૚ᄈᅅბձ๗ x &52ጺબत݀ቛ૦๏ ߸ڟခޜਏ༹ڦ๬ᄓضଣڦᄇՎǈٗড቏ڦခޜඇևࠀీڟแࡍԐǄዐࡔǅᄱ࿿য়শᇑᅅბ႑တጺ॔ x ᆯևݴࠀీ ೝႜᄱ࿿ਸ݀ڦ߾ፕଶᇘǈԈઔࡔाཞ้৊ႜڦ੻ݘ ں཈቟ǖ॔࠶࣍ৣĂට֍ਸ݀Ăዊଉ࠶૙Ăएڦऐࣷࢅ཈቟ x ඇ൰ࢅࡔా&52௬ଣڦሞዐࡔ࠶૙ᄱ࿿য়শ႑တၹᅱ ૙ǈӄ૩ݴت࿋ኮक़߾ፕ࠲ဣڇ࿋࠶૙ǈᅜत&52ࢅᄱ࿿ჺ݀ڇضଣ ዜଲᓳᅅ฾ ဆ ᆫ๞तڦዐࡔتںঙ෥ǈᅜतසࢆ૧ᆩڦඇ൰&52փ܏݀ቛڦෘ౷ݤඇ൰ᄱ࿿য়শतୁႜթևࡔाᄱ࿿য়শၹۙᇵ x ሞዐࡔ ๬ᄓ༵ࠃኧ׼ضଣڦሏႜঢ়ᄓྺሞዐࡔ৊ႜ

एԨࢅዘᄲፇׯ——ዊଉĂ቟୼Ă༹ဣࢅํแڦခޜݴׇࣷ_౎ሆනˈ႓೺ܾ ዊଉǖ&52 ࿵֫ǈ'(ǅ Թࢤߒձ๗ ੔࿔ຯඇ൰ޭጺ֋ǈዐࡔ൶ጺঢ়૙ ᆌᆩڦ၃࠶૙ዐޅ႑ࡽॠ֪ሞႎ้೺ᄱ࿿য়শࢅ ᇼৠڦሺ׊त݀ቛ——ඇ൰&52ڦ52ᄽခሞዐࡔ& ࣷᅱዷ׼ ႇᄊ՜ ଄գᅅ฾ Һ੃ዐࡔጺঢ়૙ ၃࠶૙ևோޅ࣪෌Ǆዐࡔǅჺ৯ਸ݀ᆶ၌ࠅິඇ൰Ҿඇ቟୼ևǈҾඇ֪॔त ጺ॔त޶ሴට ᇼৠڦፕᆩतۨ࿋——ࡔా&52ڦਸ݀ዐض52ሞዐࡔଣ& ࿔߾ฆ࠶૙ຬ๗ר ޅᄱ࿿ܔଶᇘăణമǈ߳ࡔᄱ॔ऐࠓࢅ዆ᄱഓᄽڦᄱ࿿য়শ๟ᅃ߲੺໏݀ቛ ૙ǈᅙׯྺ ໽߭ᅅᄱ੔रᆶ၌ࠅິฆခ݀ቛևޭጺ֋ت၄ǈԒߢࢅ݀ڦ߲ࢅඖ༹փଆ๚ॲڇܔ؜କג࠶૙ᅙᇺᇺڦ၃ ᆶऐဣཥăሞ࿢ࡔǈໜጣࡔॆᄱ೗ڦԈࡤ߳ዖံ৊ݛ݆रຍڦᅃ߲߸ྺඇ௬ ೠॏڦዐࡔ&52ܔแǈ࿢ࡔ$'5֪॔रຍ຤ೝࢅຕ਍ݴဆ ࡔाჺ݀ഓᄽํڦփଆݒᆌ֪॔႑တྪஏॺยၜణ ૙๟ᅃ߲ዘᄲ࣍ Mariano M. YOUNG ձ๗تൽĂೠॏࢅ༵ڦ૰ᄺሞփ܏༵ืǈഄዐ$'5Ҿඇ႑ࡽీ ჺ৯ጺ॔ض ߾ፕፇۨᅭഄྺđᄱ࿿ ࣪෌ᅧ௭ଣ বă๊஺๟ᄱ࿿ҾඇĐ႑ࡽĐǛ&,206 9,,, ႎ႑တǈႴڦയሞ૴ဣǈईᅙኪ૴ဣڦࢅగ߲ፇփଆ๚ॲǄݥᇨ೺ၳᅮǅ ೠॏڦዐࡔ&52ܔॠ؜੗ీઠ ࡔాჺ݀ഓᄽڦ๴ᅮǅăĐ႑ࡽđڦ၃Ǆႎޅ๟ޏೠࠚઠඓۨഄ๟ڦᄲ৊ᅃօ ૙ă ঁᰵᢢᅅბձ๗تĐ႑ࡽđ࣏Ⴔᄲ৊ᅃօෲ჋ǈೠॏǈࢅڦ߲ઠᇸǈܸॠ؜ܠጲᅃ߲ई ॿ໋࢛෌዆ᄱᆶ၌ࠅິᅅბኴႜጺ॔ ݀ڦ߲߳ݛ௬ǈৎ౎ઠڦǈሞํ७ዐሏᆩإ૙ஃएڦԨጆׇॽ঻ถ႑ࡽॠ֪ ፕᆩăڦ၃࠶૙ఇ๕ዐޅቛǈᅜतഄሞඇ൰ࣅᄱ࿿য়শࢅ

႑ࡽॠ֪ݛ݆ბᇑӄ૩ݴဆ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ࿵֫ǈ%&ǅ Robert MAKUCHձ๗ˈঞ๲ ბࠅࠌ࿐ิბᇾิ࿿ཥऺևዷඪٷბ݆ࡀ๚ခևዷඪǈᇱᄶ୛ٷெࡔᄶ୛ 52üüሞዐࡔ&ڦጱरຍۉᄱ૙ბतضჺ৯ˈԈઔଣضภतራ೺ଣ ཈቟ᇑऐᇜڦᄱ࿿Ҿඇ႑ࡽॠ֪ဣཥ঻ถǄ႑ࡽॠ֪ǈ႑ࡽෲ჋ǈࢅ႑ࡽೠॏǅ ௬ଣ Craig HARTFORD ᅅბձ๗ ࣷᅱዷ׼ ၃࠶૙ևޭጺ֋ޅ࣪෌Ǆᆈࡔǅඇ൰ჺ݀ඇ൰Ҿඇ቟୼ևඇ൰Ҿඇ֪॔त Թࢤߒձ๗ ᅱ ੔࿔ຯඇ൰ޭጺ֋ǈዐࡔ൶ጺঢ়૙ۯ$'(႑ࡽೠॏyӄ૩ݴဆࢅڟ႑ࡽॠ֪ٗ

ࠆჼࣀ Scott CUNNINGHAM Ӥଳୱ฾๚ခ໯๋೗ᇑᄱ೗ևࢇअටܙඇࡔᅅᄱ๨ׇၹࣷޭ૙๚׊ǈඇࡔᅅᄱरຍ๨ׇၹࣷ&52૴ࢇ༹ޭዷဝग़௞ ெࡔ੔࿔ ႎࢅጆᄽࣅ྿ᇵࣷ׉ခޭዷඪظກ׊ǈႎᄱ ᇔბރձ๗ ҾඇႠǈᅜत ཀৄ੃ထ౷ิ࿿रຍᆶ၌ࠅິۭ๚׊ग़ጺঢ়૙ڦධ৹๟ೠॏႎᄱۅ๬ᄓᅙᆶ߀Վǈ৑࠶ዘضৎ౎ઠǈራ೺ଣ ๬ᄓ๟Đ৊ႜ࣏๟ཕኹđ༵ࠃ੺໏ࢅߛ ेዐิ࿿ᅅᄱၹࣷዐࡔݴࣷࣷ׊ضଣܔ๟ڍᆶၳႠ႑ࡽăڦ၄ডራ݀ ඪခăڦਦ֧ኧ׼ᅙঢ়ׯྺഄݥ׉ዘᄲڦၳ ቱҹڦᅧ௭ڥԨጆׇॽࡥ߃ᅜူాඹǖ ิ࿿ૌຼᄱ——թටइ ࡔा൵๞——ፇࢇईĐंࢇđ Michel MIKHAILձ๗ڦᄱ૙ბضჺ৯ǈԈઔଣضራ೺ଣܔമړ x ࡔǅඇ൰݆ࡀ๚ခኴႜޭጺ֋ǈ๯ဝጀ֩࠳ڤՎࣅ ݯ෧ᆮຯਸ਼ԲǄڦ೺๬ᄓĂްሗ๬ᄓఇ႙Ăᅜत॔࠶࣍ৣ,ڦݛӄยऺĂթට༹ా Ăణമײ๯ْට༹ాჺ৯——݀ቛࡗڦᄱ૙ბǈ༬՚๟ሞዐࡔ৊ႜضx ଣ ጒ઄तৃࢫ݀ቛĂ཈቟ᇑऐᇜĂӄ૩ჺ৯ ݴׇࣷ7_౎ሆනˈ႓೺ෙ ᆌᆩ——('&ᆌᆩᇑമৠĂ&52ࠅິतჺ݀ڦჺ৯ዐضጱरຍሞଣۉ x ࿵֫ǈ'(ǅ ཈቟ࢅऐᇜڦᆖၚĂᅜतሞዐࡔ௬ଣڦ࿋ڇ ࠅࠌ࿐ิႴ൱ڦჺ݀ᇑ಼ጚüü঴ਦช࿄஢ፁڦᅧ௭ ቛྭڦᄱ૙ბଶᇘǖᅃ߲ඇ൰&52ضଣڦՎࣅዐ Robert Allen ASPBURY ࣷᅱዷ׼ ခඇ൰ޭጺ֋ग़ጺঢ়૙ Florence HOUNᅅბձ๗ޜᄱ૙ض੔࿔ຯǄெࡔǅଣ മெࡔ)'$ิ࿿዆೗อೠᇑჺ৯ዐ႐ᅧ௭อೠतჺ৯ևޭև׊ ๯ْට༹๬ᄓ——ऐᇜࢅ཈቟ ெࡔ)'$ཞඦࣷࡔाև૴ဝዷဝ Ⴙਯ֍ ெࡔ෗ܻएᅺࠅິ݆ࡀአ֧ᇑ቟୼ޭጺ֋ ჺ৯ዐ႐ߛपޭጺ֋ضฉ࡛ᅅᄱଣ ٳߌዐǈຶྨටຕࣷୁٷ௅౎ሀᆶྤටᅺलবႠୁߌܸຶྨăሞඇ൰ ႜǈߴඇ൰݀؜କᅃ߲য়ߢă௬ୁڦ۾౎ݥዂం+1ୁߌթӥྤăڟ ቛǈ&52ॽසࢆ݀ቛǛ݀ڦೝ໼ضጱࣅଣۉႎरຍሞዐࡔ——ໜጣ ڦጚิׂ၎ᆌ಼ڥᅃॆࠅິइڼၾǈዐࡔ6LQRYDF๟ྰڦ۾1ୁߌթ+ܔ ᅪᅭăٷჺ݀ࢅอೠአ֧ᆶጣዘڦ዆ۨႎܔRob NICHOLS +1ᅧ௭ăዘ࿒ُْ཭݀๚ॲ ߌਪዪݴ૗؜ઠࢫǈ዆ᄱᄽࢅ॔࠶ऐࠓ৽੗ᅜे໏৊ႜ၎ᆌୁٷڋोࠡ࿔Ǆᆈࡔǅඇ൰&52ࢇፕߛपጺ॔ ኄᄣǈᅃ ࣆ༶ǈԈઔܹཡࢅ઻ටᅧ௭ۨ೺ॠڦăԨጆׇॽภतዘᄲׂิڦߌᅧ௭ୁڦ ႎरຍăڦೝ໼ኮྔׂิڦጆॆ༪ஃ ᄓǈႎፒवᅜतचಡ ҵՎဦڦփཞᇀᇨݞႠᅧ௭ǈዎଐႠᅧ௭घऄ௨ᅧဣཥǈ๎՚ࢅ١༹࣯ా ǈᄺإჺ৯एضଣڦፌႎ݀ቛ๟᩺ૌዎଐႠᅧ௭ᆶྭׯࠀڦԇă዗ୀ௨ᅧბ ڦ܈ዎଐ๮܎ԥ࠲ጀڦ௨ᅧዎଐᆩᇀ቟฼ҵኢăໜጣኄዖႎڦݴׇࣷ೿_ᅧ௭ᇑิ࿿዆೗ ᆶ૧ᇀ੗থ๴ ዎଐᅜतڦጚǈԨጆׇॽ঻ถ޿ૌᅧ௭සࢆᆶዺҵኢ಼ڥනᅮ༵ߛժॷॷइ ܔ޿ૌᅧ௭සࢆ৊ႜอೠत॔࠶ă ݴׇࣷ7_౎ሆනˈ႓೺ܾ ׯजڦڥ཈቟ࢅൽڦ࿵֫ǈ'(ǅ ዐࡔ಼ጚୁߌᅧ௭ࢅഄ໲ᅧ௭௬ଣ ࠶૙ਆ঄ኁᅙᄥ൩۽ᅃևݴ ዐࡔࡔॆ๋೗ᄱ೗॔ڼႎüüظਸ݀ᇑڦᅧ௭ࢅิ࿿዆೗

৊օڦࣷᅱዷ׼ ୁߌᅧ௭ิׂरຍ ᇔბރձ๗ ᄾኾೝᅅბձ๗ ཀৄ੃ထ౷ิ࿿रຍᆶ၌ࠅິۭ๚׊ग़ጺঢ়૙ ெࡔ)'$ิ࿿዆೗อೠᇑჺ৯ዐ႐ᅧ௭อೠतჺ৯ևྲิ࿿อೠፇ޶ሴට ዐิ࿿ᅅᄱၹࣷዐࡔݴࣷࣷ׊े ۅ࠵ڦ౎+1ୁߌᅧ௭ิׂܔਗ਼ጚԢጣǖዐࡔᅧ௭ิׂഓᄽ้ ၃ೠࠚ ௕࿀ౢձ๗ޅضႎݛၠǖ)'$ଣڦ$'(ᄱ೗॔࠶ᅜतڦภतิ࿿዆೗ William SCHWIETERMAN ᅅ฾ ԛ৙੔႗ิ࿿዆೗ᆶ၌ࠅິࡔाᄽခևࡔा๨ׇླྀ࠽ߛपঢ়૙ ெࡔ&KHOVHD዆ᄱࠅິ๯ဝᅅბ࠳ ௨ᅧᇑߌකፇ޶ሴටت๬ᄓยऺᇑݴဆضമெࡔ)'$ิ࿿዆೗ዐ႐ଣ ݴׇࣷ7_౎ሆනˈ႓೺ෙ ࿵֫ǈ'(ǅ ঢ়ᄓڦ༌ሞᅧ௭ਸ݀ዐᇑ&52ࢇፕ܈ঙڦੵࡔᄱഓٗ ࠅࠌ࿐ิႴ൱ڦჺ݀ᇑ಼ጚüü঴ਦช࿄஢ፁڦMariano M. YOUNG ձ๗ ᅧ௭ ჺ৯ጺ॔ض࣪෌ᅧ௭ଣ ࣷᅱዷ׼ ࠶૙ᇑ੦዆ڦ౹௑࠲ᇀएᅺࢅဦԇዎଐ Florence HOUNᅅბձ๗ Stephan JEPARDS മெࡔ)'$ิ࿿዆೗อೠᇑჺ৯ዐ႐ᅧ௭อೠतჺ৯ևޭև׊ ბ ெࡔ)'$ཞඦࣷࡔाև૴ဝዷဝٷࡔհܷڤ ெࡔ෗ܻएᅺࠅິ݆ࡀአ֧ᇑ቟୼ޭጺ֋

࠶ᇱሶ॔ڦᅧ௭ਸ݀ࢅฉ๨಼ጚܔݴׇࣷ7_౎ሆනˈ႓೺ܾ ெࡔ ࿵֫ǈ'(ǅ Sara E. GAGNETENձ๗ ևݴ ெࡔ)'$ิ࿿዆೗อೠᇑჺ৯ዐ႐ᅧ௭อೠᇑჺ৯ևอೠᇵܾڼႎüüظਸ݀ᇑڦᅧ௭ࢅิ࿿዆೗

࠲॰࿚༶ڦമҾඇႠೠॏዐضዐଣײࣷᅱዷ׼ ሞዐࡔฤԒᅧ௭ࡗ ᇔბރձ๗ க‑ձ๗ ཀৄ੃ထ౷ิ࿿रຍᆶ၌ࠅິۭ๚׊ग़ጺঢ়૙ ዐࡔࡔॆฉ࡛ႎᄱҾඇೠॏჺ৯ዐ႐ዷඪ ዐิ࿿ᅅᄱၹࣷዐࡔݴࣷࣷ׊े ਸ݀ڦႎፒवظዎଐҵኢᅧ௭ࢅ ࡀፌႎ৊ቛ Sara E. GAGNETEN ձ๗݆ڦெࡔ)'$࠲ᇀิ࿿ૌຼᄱ

ݛአުࢇፕǛ࡛ࡃഓᄽॆᆶںࠃኧ׼ժᇑ༵ںெࡔ)'$ิ࿿዆೗อೠᇑჺ৯ዐ႐ᅧ௭อೠᇑჺ৯ևอೠᇵ ॆăߛႎरຍᇴ൶ॽසࢆ߸ࡻ ཈ڦׯजतሼ௬ଣࡗڦڥࢆዖ೺ྭǛԨጆׇॽᆯิ࿿रຍࠅິ঻ถ໱்໯ൽ ঢ়ᄓăڦႎᄱჺ݀ظ቟ǈᅜतፔ ݴׇࣷ7_౎ሆනˈ႓೺ෙ ࿵֫ǈ'(ǅ ణമጒ઄ݴဆ ᅃևݴ ྦྷಶձ๗ڼႎüüظਸ݀ᇑڦਖ਼୉ੇ༹ࢅဦԇዎଐڇ ံำᄱᄽणཷޭጺ֋ǈ๯ဝ੔ბ࠳ ࣷᅱዷ׼ ሶଫձ๗ ߛႎरຍᇴ൶݀ቛᇑঢ়ᄓ֔ ฉ࡛ෘূิ࿿ᅅᄱᆶ၌ࠅິߛपޭጺঢ়૙ ۭၬ౺ ଓౢูԨဘ๨ට௷አު༬՚ࠥ࿚ ਖ਼ڇႎୟ০ăփৈظڦਸ݀ᇑዎଐᅙঢ়ׯྺᅅଐฉᅃ߲ݥ׉ዘᄲڦ࿿዆೗ิ മৠăԨጆׇॽᆯࡔाฉڦ୉ੇ༹ዎଐᆶକׯࠀ݀ቛǈဦԇዎଐᄺ၂๖؜ࡻ ᇼৠڦਖ਼୉ੇ༹ࢅဦԇዎ ഓᄽॆڇܔ޶ሴටᇑࣷݴၛ໱்ڦጆॆࢅ዆ᄱഓᄽतჺ৯ऐࠓڦ ႎă ബၠೝձ๗ظׯजĂ၄ጒĂ൵๞Ăᅜतࢇፕᇑڦڥາ੊ǈԈઔൽڦଐ݀ቛ ໋ዝාႎิ࿿੔रᆶ၌ࠅິጺ֋ग़๯ဝኴႜ࠳ ႎӜՔȍȍ7Kဦԇཚୟڦዎଐጲว௨ᅧᄁኢթ ୔ࢢᥖձ๗ ߬ન໎๏ਖ਼Ǆዐࡔǅჺ݀หঢ়௨ᅧბևߛपጺ॔त޶ሴට ݴׇࣷ7_౎ሆනˈ႓೺ܾ ࿵֫ǈ%&ǅ ਖ਼୉ੇ༹ᄱ࿿ ӄ૩ჺ৯ࢅጆॆ༪ஃڇپႎᅃڦҵኢࢅጲว௨ᅧဣཥदթܔยऺኍׂิ Bassil I. DAHIYATձ๗ ெࡔ;HQFRUࠅິ๯ဝኴႜ࠳ ࣷᅱዷ׼

ӣਸ݀ ྦྷಶձ๗ڒਖ਼୉ੇ༹ࢅዘፇڇڦ࿿၎ຼิ ံำᄱᄽणཷޭጺ֋ǈ๯ဝ੔ბॆ ሶଫձ๗֔ ฉ࡛ෘূิ࿿ᅅᄱᆶ၌ࠅິߛपޭጺঢ়૙ ূਖ਼࿔ձ๗ ӆ᭳ཨጨࢇअට ற۬ૅ ࠶૙ਆళݛᅅᄱঢ়षჺ৯໯Ėᅅᄱঢ়षԒėბຍևዷඪǈ۽ݴׇࣷ7_౎ሆනˈ႓೺ෙ ࡔॆ๋೗ᄱ೗॔ ࿵֫ǈ'(ǅ ጨศऻኁ ևݴܾڼႎüüظቛᇑ݀ڦਖ਼୉ੇ༹ࢅဦԇዎଐڇ ᄽऐᇜᇑ཈቟ظڦศᒰᇴ൶ ࣷᅱዷ׼ ୛ံೝձ๗ ሶଫձ๗ ศᒰྲႊิ࿿ጺ֋ग़๯ဝ੔ბॆ֔ ฉ࡛ෘূิ࿿ᅅᄱᆶ၌ࠅິߛपޭጺঢ়૙ ି፵࿔ ዎଐ ໋ዝิ࿿భ௝ᇴ๯ဝኴႜ࠳.,&ڦҵኢ ቧᅫᅅბձ๗ ༀဣཥิڦᅃ޹ຌᅅᇾ዗ୀ੔༬೘ঞ๲ǈิ࿿ዎଐዐ႐ዷඪ 4%ǖٝ৊ิం੔ბ׼Ⴤ݀ቛڼბٷዐࡔኣዝ Kenneth HARRISONձ๗ ੇ༹——ဦԇᅺጱްࢇ࿿ ெࡔ%LR6)4%ၜణ޶ሴට Charlie SURHձ๗ ெࡔ7KH6FULSSVჺ৯ዐ႐ঞ๲ ጆॆ༪ஃ ༪ஃዷ׼ າ੊ ূਖ਼࿔ձ๗ڦ዗ୀဦԇዎଐ֧୼त၎࠲ࡀݔ ߛেձ๗ ӆ᭳ཨጨࢇअට ԛ৙৙௏ߛ੔߅ဦԇरຍᆶ၌ࠅິۭ๚׊

ݴׇࣷ৵_ገࣅᅅბ ႎظݴׇࣷӗ_ߛႎरຍᇴ൶

_౎ሆනˈ႓೺ෙݴׇࣷ7 ࿵֫ǈ%&ǅ ݴׇࣷ7_౎ሆනˈ႓೺ܾ ࿵֫ǈ%&ǅ ገࣅ੔ბत༹߲ࣅᆩᄱ ഔ๖ڦঢ়ᄓǃ཈቟ࢅቛྭߴᇎڦഓᄽॆ ࣷᅱዷ׼ ࣷᅱዷ׼ ॿౢਬᅅბձ๗ˈ௨ᅧბձ๗ ಶձ๗ ෘ౷ݤඇ൰ჺ݀ޭጺ֋ჱ໿൶ჺ݀ጺ֋ྦྷ ံำᄱᄽणཷޭጺ֋ǈ๯ဝ੔ბ࠳ ࿿ᅅბჺ৯ገิإ๟ॽएڍ৊ቛǈٷକ঴ᅙᆶକዘڦݴጱऐ዆ڦदթܔටૌ ূਖ਼࿔ձ๗ Đࠏڦ๴ᅮኮक़ضᆌᆩ׉׉ᅜ฿Өߢዕăሞჺ݀ᇑଣضଣڦҾඇࢅᆶၳྺ ӆ᭳ཨጨࢇअට ႎ၎ظገ࣑ڦሗႠăԨጆׇॽ਋ঋᇀᄱ೗ਸ݀ዐްڦᒬđ၂๖କට༹ิ࿿ბ ኪ๎ገڦाሏᆩํڟჺ৯ࢅ๑ᆩǈܸ༵ٗߛٗํᄓڦႎݛ݆ظۯற۬ૅ ࠲࿚༶ǈླྀ ࠶૙ਆళݛᅅᄱঢ়षჺ৯໯Ėᅅᄱঢ়षԒėბຍևዷඪǈ ࣑ၳ୲ă۽ࡔॆ๋೗ᄱ೗॔ ጨศऻኁ x ༪ஃ೟ৡ࿚༶ x ཈቟၄઄ ഓᄽڦᄽǈׯྺჺ݀ႎᄱظߛႎरຍᇴ൶ں߳ڟ࡛ྔბጱࡃࡔڦܠሁઠሁ

x አުĊჺ৯ᇾ໯Ċ߾ᄽࢇፕअӵ࠲ဣ ࣷᅱዷ׼ x ༹߲ࣅᆩᄱ ିጸݔ ຕ਍࠶૙ዐ႐ჱ໿൶ጺ॔ضਸ݀ᇑᄓኤ ఐ෭۫Ǆฉ࡛ǅᅅᄱጧკᆶ၌ࠅິඇ൰ଣڦx ิ࿿ኸՔ

ׯࠀݥ׉ዘڦ๬ᄓضଣܔ৆௢ದࢇڦኮक़ںएضခऐࠓࢅଣޜ࿋ǈڇဃ൶ ჺ݀ڦ዆ᄱഓᄽჺ݀ዐ ăتದࢇतׯࠀኮڦኮक़ںएضॿౢਬᅅბձ๗ˈ௨ᅧბձ๗ ᄲăԨጆׇॽ༪ஃᆩփཞݛ๕ेഽഓᄽᇑଣ ෘ౷ݤඇ൰ჺ݀ޭጺ֋ჱ໿൶ჺ݀ጺ֋ ت၎࠻ኮڦแǖ&'0ࢅ&5$ํضຕ਍࠶૙ᇑଣضথଣൃ ाᆌᆩ ቧ๾ํڦገࣅᅅბ ๬ᄓํแঢ়૙ضൣ஽ձ๗ ෘ౷ݤǄዐࡔǅଣྦྷ ࢅऻࣜೲᅅᄱǄฉ࡛ǅᆶ၌ࠅິገࣅᅅბत቟୼ࢇፕޭጺ֋ ႎظरຍᇑݛ݆ڦ๬ᄓضଣ ჺ݀ Susant MALLICKڦႎᄱظॽገࣅᅅბබ෇ ݴဆዐ႐޶ሴටضRJQL]DQWरຍࠅິଣ&܈৒຿ձ๗ ᆇྦྷ ෘ౷ݤዐࡔჺ݀ዐ႐ጺ֋ǈჱ໿ჺ݀ዐ႐ገࣅᅅბ޶ሴට ᅅბ႑တڥइںසࢆत้ժ׼Ⴤ ገࣅᅅბǖገࣅᅅბᇑᄱ೗ჺ݀၎঳ࢇ Henrik Nørgaard RASMUSSENձ๗ڦ७ዐํ ஛ǅ࠶૙ጧკࠅິߛपጧკࠥ࿚چ࢟ձ๗ 11,7Ǆྤ ࣪෌Ǆெࡔǅิ࿿዆ᄱገࣅᅅბᇑݴጱᅅბጺ॔ ཈቟ࢅऐᇜڦჺ৯ض࿢ࡔଣܔጱຕ਍࠶૙ۉ ႇߛഽձ๗ˈޭঞ๲ ჺ৯໯ຕ਍࠶૙ևዷضბଣٷჺ৯रຍዐ႐ǈԛ৙ضბ0HGLGDWDଣٷ_౎ሆනˈ႓೺ෙ ԛ৙ݴׇࣷ7 ࿵֫ǈ%&ǅ ඪ ገࣅ੔ბࢅ༹߲ࣅᆩᄱüüӄ૩ჺ৯ࢅጆॆ༪ஃ ጆॆ༪ஃ ࣷᅱዷ׼ ൣ஽ձ๗ ݴׇࣷ7_౎ሆනˈ႓೺ෙྦྷ ࢅऻࣜೲᅅᄱǄฉ࡛ǅᆶ၌ࠅິገࣅᅅბत቟୼ࢇፕޭጺ֋ ࿵֫ǈ׊ॿཐǅ ӄ૩ჺ৯཈቟ڦຕ਍࠶૙௬ଣ ݴׇࣷๆ_ຕ਍࠶૙ ࣷᅱዷ׼ ฬའ ခևோ࿴ࡲ޶ሴටޜຕ਍ضݴׇࣷ7_౎ሆනˈ႓೺ෙ ࣪෌Ǆ࿴ࡲǅჺ৯ਸ݀ᆶ၌ࠅິඇ൰ଣ ձ๗ג؍࿵֫ǈ׊ॿཐǅ ჿ ခևरຍሏᆐ޶ሴටޜຕ਍ضຕ਍࠶૙ ࣪෌Ǆዐࡔǅჺ৯ਸ݀ᆶ၌ࠅິଣڦჺ৯ض࠶ኸళࢅࡔाຕ਍Քጚüüଣ॔

཈቟ǈഄዐǈ࿢்჋ስڦܠ๬ᄓዐǈຕ਍࠶૙ᇵኟ௬ଣሁઠሁضࣷᅱዷ׼ ৃཀǈሞଣ ႚ๕ेᅜ঻ถǖ,೺ڦݛ௬ǈժᅜӄ૩ݴဆڦ՗Ⴀپକຕ਍࠶૙ዐଇ߲ፌਏ ຕ਍࠶૙ăڦຕ਍࠶૙ࢅ዗ୀბ๬ᄓڦձ๗ ๬ᄓجି ൶݀ቛጺ॔ںዐࣀٷ0HGLGDWD6ROXWLRQV:RUOGZLGH ࣅࢇ࿿ሞටڦǄ),+ǖ๯ْ๑ᆩᇀට༹ǅ๟ೠࠚ੗ᆌᆩᇀට ڦణڦ೺๬ᄓ, ૰ბࢅᄱၳბǅă,೺ۯپҾඇႠĂఱ๴Ⴀǈࢅิ࿿૧ᆩႠǄᄱڦՔጚࢅֶᅴ ༹๑ᆩࢫڦჺ৯ຕ਍ዊଉࢅྜኝႠضx Բডெࡔǈ౹௑ࢅዐࡔଣ ೺๬ᄓዐᅃၵํा,ڥӄ૩ݴဆॽྺ֖ࣷኁ༵ࠃऐࣷᅜइڦຕ਍࠶૙ڦዘᄲႠ ๬ᄓڦ૙঴ຕ਍࠶૙ሞຕ਍঳ࡕࢅԒߢዊଉԍቱዐ܈x ٗᄱ೗॔࠶ঙ ǈბသ,೺๬ᄓڪײঢ়ᄓǈසຕ਍๭णĂ இडॠֱᅜतຕ਍ൣ૙ࡗڦሴඪߌ ֡ፕڦx ཥᅃඇ൰ຕ਍Քጚᅜሺഽຕ਍࠶૙ փཞݛ݆ǈᅜतຕ਍࠶૙๔ዕྷජཥऺݴဆऺࣄڦยऺዐ߳ዖᄱ࿿༑໭๑ᆩ ڟ࣮ټຕ਍࠶૙ᇵ੗ᅜॽኄၵঢ়ᄓضǈᅜՍଣڪۅዷᄲჺ৯ዕڦᄱአࡀݔࢅ Ǆ6$3ǅዐڦჺ৯ຕ਍࠶૙ᆶ࠲ضሞԨ༪ஃࢫǈᇑࣷኁీକ঴ெࡔ)'$ᇑଣ න׉߾ፕዐăڦຕ਍࠶ ߳ጲܔ$'(ᄱአࡀݔࢅํ७ǈኪၬ6ڦჺ৯ຕ਍࠶૙ض७ǈຄဒ౹௑ଣํ ᄲ൱ăڦ૙ኰሴ ຕ਍࠶૙ᇵᆌ޿କ঴ڦ૙঴ &5) ยऺࢅຕ਍ੰॺ૬ǈ዗ୀბ๬ᄓں߸ࡻྺ ༬๺ఇ੷ǈසڦǈ5(&,67ኸళǈ710ݴ೺ဣཥǈᅜतᅃၵຕ਍֑ण)$&7& ڗጱᇸ࿔ۉჺ৯ዐضଣ ǅڪ዗ୀბ૦๏ǈ዗ୀ֪ଉǈᅜतമዎଐ๏ Ǆन๮ຍ๏Ă ࣅଐ๏ࢅݣଐ๏ ঢ়ᄓăڦຕ਍࠶૙ڦ๟ᄲݴၛ࿢்ሞ዗ୀბ๬ᄓዐڦణڦByungja MARCIANTE ăԨӄ૩ݴဆ ॠֱᇵتெࡔ)'$ฉ࡛Ӹ๚ ,ӄ૩ݴဆ Քጚᇑํ७ڦ๬ᄓຕ਍࠶૙ض౹௑ଣ ຕ਍࠶૙ڦVincent YEUNG ձ๗ˈ߾ฆ࠶૙ຬ๗ ,೺๬ᄓ ॠֱᇵ ฬའຬ๗۽ᆈࡔᄱ೗ᅅଐׂ೗॔࠶ਆ*&3ևோ޶ሴටǈߛप॔ ࣪෌Ǆ࿴ࡲǅჺ৯ਸ݀ᆶ၌ࠅິ Քጚᇑํ७ڦ๬ᄓຕ਍࠶૙ضዐࡔଣ ,,࠶૙ਆ঄ኁᅙᄥ൩ ӄ૩ݴဆ۽ዐࡔࡔॆ๋೗ᄱ೗॔

ຕ਍࠶૙ڦ዗ୀბ๬ᄓ ጆॆ༪ஃ ձ๗ރᇔר ຕ਍࠶૙ضခևோଣޜղଠ߭ᅻ߭ࡪǄනԨǅᅅბຕ਍ ݴׇࣷ7_౎ሆනˈ႓೺ෙ ࿵֫ǈ׊ॿཐǅ ݴׇࣷๆᅃ_ᅅბ੔ბ๚ခ ၎ࢻದࢇڦኮक़ںएضຕ਍ዊଉüüेഽ዆ᄱഓᄽᇑଣ

ݴׇࣷ7_౎ሆනˈ႓೺ෙ ࿵֫ǈ%&ǅ ፕᆩڞༀ࣍ৣዐᅅბዷۯ

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Conference Agenda Vaccine andBiologics • • Translational Regulations andHarmonization Medicine • MedicalandScientiﬁcAffairs • • Medical Development inHigh-Tech Parks Devices • DrugSafety andPharmacovigiliance • CROCollaboration andServices • ClinicalDataManagementandStatistics • ClinicalResearch andQA/QC • • CMC/cGMP THEMES ANDHOT TOPICS We cordially invite you to join usinthisgrand event! biologics. supplies, requirement andpractices onmedicaldevices, vaccine and cine, CRO collaboration andservices, active pharmaceutical ingredient ial pharmaceutical development inhigh-tech parks,translational medi- new areas suchasregional research anddevelopment, entrepreneur- tory affairs, clinical research andsafety, statistics, CMC,etc., butalso Programs intheConference feature notonlytopics suchasregula- exhibition. China regulatory officials, roundtablediscussion, debate, posters, and shops onAPIinspectionsparticipated by USFDA, EDQM,Asiaand regulatory update from theCenter ofDrugEvaluation ofSFDA, work- conference workshops, specialsessions andhottopics includingthe The Conference willhave plenaryandparallel sessions, includingpre- ous hottopics related to Chinaandglobalpharmaceuticals. Innovation inChina”,experts andleaderswilldiscuss andaddress vari- cordance withtheannualmeeting’s maintheme-“Collaboration and research institutions, regulatory agencies,andhealthministries. Inac- gether professionals from thepharmaceutical industry, academicand 4th DIAChinaAnnualMeetingwillbeheldinShanghaiandbringto- Simultaneous Translation Will beAvailable OnMay 21-23 681'$<0$<_35(&21)(5(1&(:25.6+23621/<

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Full-Day Workshop 1 suitability of local regulatory guidelines and development programs in accounting for these differences. Since knowledge on this topic 08:30 -17:30 (3/F, 3E) is only recently emerging, it is possible the importance of ethnicity ETHNICITY AND MULTI-REGIONAL DRUG DEVELOPMENT will continue to evolve. So, then what should be the responsibilities of local governments versus companies in ethnicity research? INSTRUCTORS KEY TOPICS Feng GUO, PhD Head of Wuhan Research and Development Center, Pﬁzer (China) • International Drug Development & Approval Strategy: Focus on Research & Development, China Ethnicity Aspects in US and China • Ethnic differences in PK and PD Pei HU, MD, PhD • Global Clinical Trial - Design Aspects Professor and Director, Clinical Pharmacology Research Center, • Global Data-Based Drug Evaluation- CDE of SFDA Perspective Peking Union Medical College Hospital, China • An Academic’s Experience in Developing Drugs for the Chinese Hsien- Ming James HUNG, PhD Market Director, Division of Biometrics I, Office of Biostatistics, Center for • A cancer drug development case study: EGFR story Drug Evaluation and Research (CDER), FDA, USA • US FDA large outcome MRCT Trials and Thrombosis Case study Haiyan LI, Professor PLATO Trial Director, Drug Clinical Trial Center, Peking University 3rd Hospital • Some Experiences with Global Clinical Trials in Cardio-Renal Associate Director, Peking University Clinical Research Institute, and Psychiatry Applications China LEARNING OBJECTIVES Bob POWELL, PharmD Senior Advisor, Clinical Pharmacology, Roche R&D Center (China) • To review ethnicity science for disease (biology, demographics, Ltd., China morbidity, mortality) and pharmacology-therapeutics (dose- Peng WANG response, efficacy, safety). Project Manager, Office of Management and Communication, Center • To consider the impact of global development scenarios when for Drug Evaluation, SFDA, China drugs are developed in one region and seek registration in others. William WANG, PhD • To review the regulatory, statistical issue, clinical and operational Head of Asia Paciﬁc Hub, Biostatistics and Research Decision issues in global development. Sciences (BARDS), Merck Research Laboratories, Merck & Co., Inc, • To review global regulatory guidelines regarding ethnicity and China multi-regional clinical development.

COURSE DESCRIPTION TARGET AUDIENCE

Over the past 10 years it has become clear there are significant • Physicians, biostatisticians, clinical pharmacologists, regulatory ethnic differences in disease and drug dose-response, efficacy affairs and safety. These differences are not well reflected in either ICH • Pharmaceutical industry (preclinical, pre-market, post-market E5 (1997 publication preceded this knowledge) or local regulatory development, IT) guidelines. The purpose of this conference is to explore the • Contract research organizations scientific importance of known differences on disease and drug • Government organizations (CDE) dose-response, efficacy and safety. We will also explore the • Academia

• Vendors of detection technologies that can used to identify counterfeit/falsiﬁed and substandard APIs. Full-Day Workshop 2 08:30 -17:30 (5/F, 5F) Full-Day Workshop 3 CHINA ACTIVE PHARMACEUTICAL INGREDIENTS (APIS) - 08:30 -17:30 (5/F, 5J) REGULATIONS AND INSPECTIONS BUILDING GCP QUALITY INTO E-CLINICAL ARCHITECTURE INSTRUCTORS - CONCEPTS AND PRACTICES OF COMPUTER VALIDATION

John D. AYRES, MD, JD INSTRUCTORS Senior Director, Global Patient Safety, Eli Lilly and Company, USA Helena Van den DUNGEN Jeffrey GREN Global Head of DS&E QA, Novartis Pharma AG, Switzerland Director, Office of Health and Consumer Goods, U.S. Department of Commerce (DOC), USA Earl HULIHAN, Professor US Co-Chair of China-US Joint Commission on Commerce and Principal Associate, EW Hulihan and Associates, Inc., USA Trade (JCCT) Pharmaceutical Task Force, USA Daniel LIU, PhD Junguo HAO Director, China Development, Medidata Solutions Worldwide, China Regional Director, Asia Pacific, Global Security, Pfizer Inc., China Beat E. WIDLER, PhD Susanne KEITEL, PhD Managing Partner, Widler & Schiemann Ltd., Switzerland General Director, Council of Europe, European Directorate for Quality of Medicines (EDQM), France COURSE DESCRIPTION Chin Chin LIM, PhD Computerized systems and electronic data management have Lab Director, Forensic Chemistry & Physics Lab, Forensic Science been embedded into clinical research at a rapid pace, in all kinds of Division, Applied Sciences Group, Health Sciences Authority, applications. Globally, EDC applications are involved in more than Singapore 50% of clinical studies. In China, EDC is in the initial stage of its Steven WOLFGANG, PhD implementation. Many of the users of these computerized systems Acting Associate Director, Risk Science, Intelligence, and in clinical research environments are aware of the importance for Prioritization, Center for Drug Evaluation and Research (CDER), data quality and data integrity for their patients. However, they Office of Compliance, Office of Drug Security, Integrity and Recalls, often underestimate (if they realize at all) the impact that the use of US FDA, USA electronic applications and computerized systems and transmission Wei ZHANG of patient data to remote sites may bring to the quality and Director General, Department of Drug Registration, SFDA, China integrity of data as well as assurance of patient safety. This one-day workshop to viewing validation activities should enable the actual COURSE DESCRIPTION users of the systems to understand and work with the systems in a validated state, making and keeping them fit for use. Moreover, this This workshop is one of the projects planned by China-US Joint workshop is to introduce a current bench mark for design, testing, Commission on Commerce and Trade (JCCT) Pharmaceutical implementation and retirement of computerized systems in use in Task Force in 2012 Working Plan. The workshop will focus on APIs clinical research. At the same time an incorporation of options that regulation and inspection. Officials from China SFDA and US FDA are already visible for future application and best practices will be will present the current regulatory regime for APIs. A panel will covered. The workshop will endeavor to build a validation model discuss APIs regulation systems worldwide, including internet sell that can be applied to various types of e-clinical systems, taking and anti-counterfeit APIs. Officials and API experts from European into account the unique nature of research on human subjects. and Asia regulatory authorities and the representatives of multi- nation pharmaceutical companies will lead the panel discussion and LEARNING OBJECTIVES round table discussion with all participants on the subjects of how to control counterfeit APIs, law enforcement, and future cooperation. • Understand the status of computer system validation (CSV) in the GxP regulations. LEARNING OBJECTIVES • Learn definition and practice of (CSV), especially controls of the system life cycle (SLC) for the development of quality • Understanding the regulation system for APIs in US and other computer systems used in clinical studies. countries. • Establish a specific process that may be used as documented • Learning SFDA's perspectives on APIs regulation. evidence that provides a high degree of assurance of • Increasing the confidence on Chinese produced APIs used in specifications and quality attributes of the computer system in medicines. daily working life. • Intensifying the awareness of APIs quality assurance and • Ensure that computerized systems are fit for the intended use increasing surveillance and enforcement of Chinese produced in ‘real life’ clinical trial settings. APIs/Chemicals that are not approved by drug authority being • Be helpful to staff at investigational sites, contract research used for the production of drug products, or for the counterfeit/ organizations (CROs), central laboratories and specialty falsified medicines. vendors supporting clinical trial activities. • Strengthening the recognition of the importance of international cooperation in cracking down counterfeit APIs. TARGET AUDIENCE

TARGET AUDIENCE Professionals involve in the clinical study area of: • Clinical management and operation • Regulators (reviewers, inspectors and lab scientists, etc.). • Clinical IT professionals and supporters • APIs manufacturers. • Clinical informatics • R&D scientists and managers. • Clinical monitors • Quality Assurance and Quality Control professionals. • Regulatory affairs

• Data management and programmer • How to interpret the “Guideline for Management of New Drug • Vendor management and supports Phase I Trial” issued in Dec 2011? • Drug research and development • What is the status of FIH trial in other Asian countries or region? • Technique supports related to computer systems in clinical • “The First-in-Human Oncology Phase I Trials in Taiwan”. studies • In South Korea, Singapore or Hong Kong?

TARGET AUDIENCE Full-Day Workshop 4 Anyone who is involved the clinical study area below would be 08:30 -17:30 (3/F, 3G) necessary to participate this workshop FIRST IN HUMAN (FIH) • Anyone who is interested in FIH trials • Clinical management and operation CO-CHAIRS • Medical Affairs/ Medical Advisor • Clinical monitors Dan ZHANG, MD • Regulatory affairs CEO, Fountain Medical Development Ltd., China • Pharmaceutical industry (preclinical, pre-market, translational sciences) Carol ZHU, MBA • Contract research organization CEO, START (South Texas Accelerated Research Therapeutics), Shanghai, China

INSTRUCTORS Full-Day Workshop 5 08:30 -17:30 (5/F, 5H) Pei HU, MD, PhD DRUG RISK ASSESSMENT AND MANAGEMENT AT US Professor and Director, Clinical Pharmacology Research Center, Peking Union Medical College Hospital, China FDA- A CASE STUDY OF DRUG THAT WAS MARKETED, WITHDRAWN AND THEN REINTRODUCED IN US MARKET Helen JIANG, MD, PhD Executive Medical Director,Jiangsu Hengrui Medicine Co., Ltd., China INSTRUCTORS Chia-Chi (Josh) Lin, MD, PhD Director of Phase I Center, Department of Oncology, National Mark J. GOLDBERGER, MD, MPH Taiwan University Hospital Former Office Director, CDER Office of Antimicrobial Products FDA Alumni Association Anthony TOLCHER, MD Vice President, Abbott Regulatory Intelligence and Policy, USA Director, Clinical Research, START (South Texas Accelerated Research Therapeutics) LLC. USA Florence HOUN, MD, MPH, FACP Former Director, Office of Drug Evaluation III, US FDA/CDER Dan ZHANG, MD Co-Chair of FDA Alumni Association International N etwork CEO, Fountain Medical Development Ltd., China Vice President, Celgene Regulatory Policy and Strategy, USA COURSE DESCRIPTION Zili LI, MD, MPH Former Medical Team Leader, Office of New Drug Review, US Food Scientifically and effectively evaluate the new medicines has been and Drug Administration (USFDA), Center for Drug Evaluation and emphasized by SFDA again during the “National Clinical Research Research (CDER) Quality Management Conference “ on Dec 8, 2011. To facilitate the Co-Chair of FDA Alumni Association International Network development of “significant innovative new medicines” and to Executive Director, Head of Emerging Market Regulatory Strategy provide the services to the establishment of innovative country, it and Liaison, Merck & Co., USA is critical to upgrade the capacity and capability of First-time-in- Human trial in China. Since 1998, MOH and SFDA had issued China GCP and a series of COURSE DESCRIPTION provisions on certification and quality inspection of the clinical pharmacologic unit. This is an one-day (6 hours) advance-level case-based study, However, some aspects still need to be improved, especially in including structured didactic sessions, discussions and hand- capability of clinical trial design for innovative drug and the ability on practice. The course is based on public information on a drug of risk management of Phase I clinical trials seemed to be the most product that was approved, then withdrawn and then reintroduced prominent problems. Therefore, we think it is important to hold this again in US market. The instructors were former FDA reviewers and full day workshop on FIH trial from the definition, to the key design senior management who were extensively involved in the regulatory considerations, the operation challenges as well as to share the decision making of the case. There will be three 2-hour sessions perspectives from peers of this region. Since SFDA has just issued covering three periods, i.e. preapproval, approval-withdrawal, and a new guideline for Management of New Drug Phase I Trial in Dec withdrawal-reintroduction in a chronologic order. At each session, 2011, we would also like to invite relevant SFDA officials to provide after a brief introduction, all participants will be provided with data the interpretation of this document. and/or shown parts of FDA advisory committee video and followed by an interactive discussion or role-playing. LEARNING OBJECTIVES LEARNING OBJECTIVES • Understand key study design considerations of FIH study such as DLT, MTD, how to choose the starting dose of FIH, how to • Understand the foundation and application of science-based recommend dose for phase II trial. decision-making principle in US FDA. • What will be key questions to ask during the FIH trial? • Understand the risk/benefit tools used in assisting in regulatory • What are the measures for risk management? decision making. • How will the study be different for a Phase I study in health • Understand the importance of good review practice, including volunteer vs. in patient? good communication between industry and regulatory agency. • What are the operational challenges for FIH in oncology patients? TARGET AUDIENCE

Medical writers, investigators, clinical research and regulatory This advanced-level course is designed for professionals with affairs staff a considerable drug development experience and high level of English proficiency. General requirement: at least 5 years of combined experience in any of the following fields: development of clinical trial protocol, development of regulatory strategy for drug registration, monitoring of clinical trial execution or drug safety assessment/risk management. Also it is highly desirable that you have had experience in giving a formal presentation in English at your work or at conference/workshop. Given the interactive nature of this course, the max class size is limited to 50 people in five small groups in order to maximize the effectiveness of this course.

Half-Day Workshop (Morning) 08:30 -12:00 (5/F, 5I) ETHICAL MEDICAL WRITING PRACTICES - EVERY DOCUMENT, EVERY TIME, EVERY COUNTRY!

INSTRUCTORS

Karen WOLLEY, PhD, Professor CEO, ProScribe Medical Communications, China

COURSE DESCRIPTION

This popular and highly rated workshop will be re-offered again this year! Medical writers in China are making increasingly important contributions to documents designed to reach international audiences. Writers are being asked to prepare many types of documents, including publications in international peer-reviewed journals, presentation materials for international conferences, protocols for international clinical trials, and clinical study reports for international regulatory submissions. Although each document has speciﬁc requirements, EVERY document must be prepared in an ethical manner. Thus, medical writers in China (and throughout the world!) must be aware of and adhere to ethical medical writing practices. Failure to do so could endanger patient care and damage the reputations of the writer, the sponsor, the institution, and the country involved. At this workshop, the facilitator will: • Provide attendees with real-life examples to reinforce why ethical practices are critical. • Identify important international guidelines, which attendees can use after the workshop. • Highlight critical ethical practices writers should follow when preparing different types of documents (eg, protocols, clinical study reports, abstracts, slides, posters, manuscripts). • Enable attendees to test their knowledge before and after an in-depth review of ethical publication practices. • Encourage attendees to discuss how they might solve ethical medical writing challenges, which will be raised through a number of real-world scenarios. The facilitator will follow adult learning principles and use a mix of didactic and interactive styles to cater to different learning preferences. All activities will be conducted in a culturally respectful manner.

LEARNING OBJECTIVES

By the end of this session, attendees should be able to: • Justify why medical writers in China should follow internationally recognized ethical medical writing practices. • Identify important international guidelines that describe ethical medical writing practices. • Apply ethical medical writing practices when preparing different types of documents.

TARGET AUDIENCE

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THEME 1 THEME 2 THEME 3 THEME 4 THEME 5 THEME 6 CLINICAL RESEARCH REGULATORY CMC / GMP STATISTICS DRUG SAFETY CRO DEVELOPMENT & OPERATIONS AFFAIRS

08:30 - 10:00 PARALLEL THEMES

Session T 1-1 Session T 2-1 Session T 3 -1 Session T 4-1 Session T 5-1 Session T 6-1 (1/F, Century Hall) (3/F, Yellow River Hall) (3/F, 3C+D) (5/F, Yangtze River Hall) (5/F, 5D+E) (5/F, 5B+C) Managing Productivity Experience of CDE SRP CMC Strategies and Non-inferiority Trial Pharmacovigilance CRO Development in Paradox: Can We Get Formal Consultation Practices Guidance and Adaptive (PV) Aspect of Due China More by Demanding Design Guidance Diligence and Licensing Less? Agreement

10:00-10:30 TEA BREAK (1/F, Mandarin Hall)

THEME 1 THEME 2 THEME 3 THEME 4 THEME 5 THEME 6 CLINICAL RESEARCH & REGULATORY AFFAIRS CMC / GMP STATISTICS DRUG SAFETY CRO DEVELOPMENT OPERATIONS

10:30 - 12:00 PARALLEL THEMES

Session T 1-2 Session T 2-2 Session T 3 -2 Session T 4-2 Session T 5-2 Session T 6-2 (1/F, Century Hall) (3/F, Yellow River Hall) (3/F, 3C+D) (5/F, Yangtze River Hall) (5/F, 5D+E) (5/F, 5B+C) Remodeling Patient Science-based CMC Strategies and Non-inferiority Trial Signal Detection in a Early Clinical Research Enrollment Strategies Regulatory Decision- Practices - GMP Guidance and Adaptive New Era CRO Including Clinical and Execution Making: Reality or Compliance and Design Guidance Pharmacology, E - Aspiration? Quality technology in Clinical - US FDA Experience Reserach - Challenges and Opportunities in China

12:00 - 13:30 LUNCH BREAK (7/F, Grandball Room 2+3)

THEME 1 THEME 2 THEME 3 THEME 4 THEME 7 THEME 8 CLINICAL RESEARCH REGULATORY CMC / GMP STATISTICS VACCINE AND INNOVATION IN HIGH- & OPERATIONS AFFAIRS BIOLOGICS TECH PARKS

13:30 - 15:00 PARALLEL THEMES

SFDA/Center for Drug Evaluation (Cde) Townhall Session T 4-3 Session T 7-1 Session T 8-1 (7/F, Grandball Room I) (5/F, Yangtze River Hall) (5/F, 5D+E) (5/F, 5B+C) High Throughput Based Vaccine and Biologics What We’ve and Quantitative Biomarker Development and Can Learn From Development for Innovation- Part I - Entrepreneur’s Drug Research and Experience, Challenges, Development and Perspectives

15:00 - 15:30 TEA BREAK (1/F, Mandarin Hall)

THEME 1 THEME 2 THEME 3 THEME 4 THEME 7 THEME 8 CLINICAL RESEARCH REGULATORY CMC / GMP STATISTICS VACCINE AND INNOVATION IN HIGH- & OPERATIONS AFFAIRS BIOLOGICS TECH PARKS

15:30 - 17:00 PARALLEL THEMES

SFDA/Center for Drug Evaluation (Cde) Townhall Session T 7-2 Session T 8-2 (5/F, 5B+C) 15:30 - 17:30 (7/F, Grandball Room I) (5/F, 5D+E) Vaccine and Biologics Case Studies and Panel Development and Discussion Innovation- Part II

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08:30 - 10:00 PARALLEL THEMES

Session T 1-5 Session T 2-5 Session T 3 -5 Session T 4-5 Session T 7-3 Session T 9-1 (1/F, Century Hall) (3/F, Yellow River Hall) (3/F, 3C+D) (5/F, Yangtze River Hall) (5/F, 5D+E) (5/F, 5B+C) Establishment and Medical Devices CMC for Drug Products Design and Analysis of Vaccine Development Translational Science Improvement of and Combinational Proof-of-Concept and and Approval for and Personalized Management System at Products - Regulatory Dose-Finding Studies Unmet Needs Medicine Clinical Sites Process and Practices in Drug Development

10:00-10:30 TEA BREAK (1/F, Mandarin Hall)

THEME 1 THEME 2 THEME 3 THEME 10 THEME 7 THEME 9 CLINICAL RESEARCH REGULATORY CMC / GMP DATA MANAGEMENT VACCINE AND TRANSLATIONAL & OPERATIONS AFFAIRS BIOLOGICS MEDICINE

10:30 - 12:00 PARALLEL THEMES

Session T 1-6 Session T 2-6 Session T 3 -6 Session T 10-1 Session T 7-4 Session T 9-2 (1/F, Century Hall) (3/F, Yellow River Hall) (3/F, 3C+D) (5/F, Yangtze River Hall) (5/F, 5D+E) (5/F, 5B+C) Clinical Site Capability PMDA Update CMC for Drug Products Regulatory Guidelines Vaccine Development Translational Science Development -PMDA's Current and International and Approval for and Personalized Status and Future Data Standards -Data Unmet Needs Medicine - Case Direction Management in Clinical Studies and Panel Studies Discussion

12:00 - 13:30 LUNCH BREAK (7/F, Grandball Room 1)

THEME 1 THEME 2 THEME 3 THEME 10 THEME 7 THEME 11 CLINICAL RESEARCH REGULATORY CMC / GMP DATA MANAGEMENT VACCINE AND MEDICAL AND & OPERATIONS AFFAIRS BIOLOGICS SCIENTIFIC AFFAIRS

13:30 - 15:00 PARALLEL THEMES

Session T 1-7 Session T 2-7 Session T 3-7 Session T 10-2 Session T 7-5 Session T 11-1 (1/F, Century Hall) (3/F, Yellow River Hall) (3/F, 3C+D) (5/F, Yangtze River Hall) (5/F, 5D+E) (5/F, 5B+C) Inspections Strategy IP Protection in New Implementation of New Data Quality - Monoclonal Antibody Medical Leadership in a and Methodology - Drug Development and Other ICH Quality Improvement of and Cell Therapy Dynamic Environment Current & Future Guidelines Interactions Between Development and Industry and Innovation - Part I Investigational Sites

15:00 - 15:30 TEA BREAK (1/F, Mandarin Hall)

THEME 1 THEME 2 THEME 3 THEME 10 THEME 7 THEME 11 CLINICAL RESEARCH REGULATORY CMC / GMP DATA MANAGEMENT VACCINE AND MEDICAL AND & OPERATIONS AFFAIRS BIOLOGICS SCIENTIFIC AFFAIRS

15:30 - 17:00 PARALLEL THEMES

Session T 1-8 Session T 2-8 Session T 3-8 Session T 10-3 Session T 7-6 Session T 11-2 (1/F, Century Hall) (3/F, Yellow River Hall) (3/F, 3C+D) (5/F, Yangtze River Hall) (5/F, 5D+E) (5/F, 5B+C) Quality Management Generics - Regulatory Implementation of New Facing the Data Monoclonal Antibody Roundtable Discussion: System (QMS), Quality Challenges and and Other ICH Quality Management and Cell Therapy Medical Affairs vs. by Design (QbD) Opportunities Guidelines Challenge: Case Development and Clinical Development, and Quality Risk Studies Innovation - Part II Is It a Reality or Management (QRM) in Aspiration? Clinical Research

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07:30 - 16:00 REGISTRATION OPEN (1/F, Exhibition Hall)

API MANUFACTURING FACILITIES INSPECTION - BEST PRACTICES AND STRATEGIES (INVITED REGULATORS ONLY)

13:30 - 17:30 OPENING PLENARY SESSION (All Registrants are encouraged to attend ) (7/F, Grandball Room I) Welcome Remarks, Keynote Presentation, and Award Presentations • OPENING REMARKS YIN Li, MD Commissioner, State Food and Drug Administration (SFDA), China • KEYNOTE SPEECH 1 David D. HO, MD Founding Scientiﬁc Director and Chief Executive Officer, Aaron Diamond AIDS Research Center, Irene Diamond Professor, Rockefeller University, USA • KEYNOTE SPEECH 2 Alberto GRIGNOLO, PhD Corporate Vice President, Global Strategy and Services, PAREXEL International, USA 17:30 - 19:30 RECEPTION (ALL) (1/F, Exhibition Hall)

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THEME 1 | CLINICAL RESEARCH & OPERATIONS Session T 1-2 | Tuesday, May 22, 2012 10:30-12:00 (1/F, Century Hall) REMODELING PATIENT ENROLLMENT STRATEGIES AND EXECUTION Session T 1-1 | Tuesday, May 22, 2012,

8:30 - 10:00 (1/F, Century Hall) SESSION CHAIR MANAGING PRODUCTIVITY PARADOX: CAN WE GET MORE BY Jessica LIU, MD DEMANDING LESS? General Manager, China and North Asia, INC (Beijing) Medical Technology Co., Ltd., China SESSION CHAIR Paul DAI, MD This session will cover the topics of patient recruitment tools and Senior Director, Regional Head of ICRO AMAC & Greater China practice in the clinical trials. Region, Beijing Norvartis Pharma Co., Ltd., China Accelerated patient recruitment is always a challenge and deserves great attention on planning and execution. Speakers in this section One of the biggest challenges in the drug development industry will talk about: is to improve the efficiency in late stage clinical development, this • Robust tools/methodology being developed for country/ session is going to share some new and innovative approaches that site selection analysis, as well as patient enrollment timeline enable us to enhance our productivity in a new paradigm. simulation and forecast, which will help the study team to plan the project budget and resource. Remote Monitoring • Inspiring strategies and practices on patient recruitment in Qing ZURAW, MD, MBA China, in order to catch up the delayed study start up in China Executive Medical Director, Covance Inc., USA due to long RA approval timeline. Increasing Protocol Compliance in Clinical Trials through Technology Panelists with rich experience in China will join the panel discussion to clarify and discuss the points and questions posed from the Malcolm BURGESS, PhD speech. Q&A will increase the interactions and share the best Executive Vice President, ICON Clinical Research, Asia Paciﬁc, ICON practice globally and locally. Clinical Research, Hongkong, China

PANEL DISCUSSION Robust Tools on Study Country Feasibility and Patient Recruitment Forecast for A Multiple Country Trial Productivity Enhancement with Various Innovative Approaches & Jeffrey ZUCKER, MS Tools Senior Director, Global Head of Feasibility, Patient Recruitment & Site Identiﬁcation, INC Research, USA

Patient Recruitment Strategy and Practice in China to Maximize the Session T 1-6 | Wednesday, May 23, 2012 Opportunity 10:30-12:00 (1/F, Century Hall) Haibo WU CLINICAL SITE CAPABILITY DEVELOPMENT CEO, Giant Med-Pharma Services, Inc., China

SESSION CHAIR PANEL DISCUSSION Yan CAI, MD, PhD A PANELIST: DDITIONAL Senior Director, Head of Global Clinical Operations (GCO), China, Shyard WONG, MD Janssen Pharmaceutical, a Johnson & Johnson Company, China Asia Regional Head, Clinical Study Unit, Sanoﬁ (China) Investment Co., Ltd., China What are the gaps for study sites to deliver high quality clinical trials, especially in phase I or vaccine study? In this session, the speakers will share experience with the participants in developing Session T 1-3/T2-3/T3-3 | Tuesday, May 22, 2012 site capabilities. 13:30 - 15:00 (7/F, Grandball Room I) SFDA/CENTER FOR DRUG EVALUATION (CDE) TOWNHALL ARO’s Role to Support the Site in Building up the Research Capability • Overall introduction to CDE Jean Paul DESLYPERE CEO, Pharmatrain Global Institute, Singapore • Decision-Making Path for Technical Evaluation • Technical Evaluation Guidelines System High Quality Phase I Study • Hot Topics in Clinical Trial Carol ZHU, MBA • Clinical Trail Risk Control for Innovative Drug CEO, START Shanghai Company Ltd, China

Enhance Site Capability – The Role of Institute of Drug Clinical Trial Session T 1-4/2-4/3-4/4-4 | Tuesday, May 22, 2012 (GCP Center) 15:30 - 17:30 (7/F, Grandball Room I) Huafang LI, MD, PhD SFDA/CENTER FOR DRUG EVALUATION (CDE) TOWNHALL Chief Psychiatrist, Shanghai Mental Health Center, China

• Overall introduction to CDE DEBATE • Decision-Making Path for Technical Evaluation Clinical Study Coordinators (CRCs) in China • Technical Evaluation Guidelines System • Hot Topics in Clinical Trial Is Clinical Research Coordiinator (CRC) a solution of the resource • Clinical Trail Risk Control for Innovative Drug issue at study site? What challenges are we facing when using CRC? From this debate, the audience will know more about the current status of CRC in China. Session T 1-5 | Wednesday, May 23, 2012 8:30 - 10:00 (1/F, Century Hall) FACILITATOR: ESTABLISHMENT AND IMPROVEMENT OF MANAGEMENT SYSTEM Ning XU, MD, MBA AT CLINICAL SITES Vice President, Head of Clinical Development Service, Covance, China

SESSION CHAIR DEBATORS: Haiyan LI, Professor Christina PING Director, Drug Clinical Trial Center, Peking University 3rd Hospital CEO, Chelsea Clinical Research, China Associate Director, Peking University Clinical Research Institute, Yan CAI, MD, PhD China Senior Director, Head of Global Clinical Operations (GCO), China, Janssen Pharmaceutical, a Johnson & Johnson Company, China As for infrastructure of study sites, the Management System is very important for conducting high quality clinical trials. In this session, we will discuss how to establish Quality Management System in Session T 1-7 | Wednesday, May 23, 2012 study sites. 13:30 - 15:00 (1/F, Century Hall) ARO (Academia Research Organization) in Clinical Research INSPECTIONS STRATEGY AND METHODOLOGY - CURRENT & Denise CLARKE-HUNDLEY FUTURE Senior Director, Operations, George Clinical Institute, Australia SESSION CHAIR Clinical Trial Information Management System in Phase I Unit Hannah CHEN, MD Zeyuan LIU, Professor Clinical QA Regional Manager, Asia Paciﬁc Quality Capability Director, Clinical Pharmacology Department, Beijing 307 Hospital, Development and Clinical QA, Global Quality and Compliance, GSK, China China

CTONG (Chinese Thoracic Oncology Group) and Its Role in Leading With the implementation of centralized remote data monitoring Lung Cancer Clinical Research in China systems, the FDA, EMA, Canada and SFDA experts will share progress and initiatives on inspection strategies and methodologies Shun LU, Professor including best practices at investigator sites and sponsors. Followed Director, Shanghai Lung Cancer Center, Shanghai Chest Hospital, by open discussions audience will gain a better understanding of Shanghai Jiaotong University, China the regulatory expectations for conducting clinical trials with new Vice Director, Chinese Society of Lung Cancer technologies.

Oversite of Clinical Investigations: A Risk-based Approach to

Monitoring (Draft Guidance) SFDA issued the regulation of "SPECIAL EXAMINATION AND Byungja MARCIANTE APPROVAL IN NEW DRUG REGISTRATION" in January 2009. This Investigator, US FDA Shanghai Office, China is one of most important milestones for SFDA, which set up the formal consultation system during new drug evaluation in China. It provides more transparent communication to sponsors. Sponsors MHRA Inspections, Current Status and Future Developments can apply for formal consultation meetings at each stage of new Vincent YEUNG, PhD, MBA drug development and discuss with health authority on scientiﬁc GCP Operations Manager and Senior GCP Inspector, Medicine and topics which will direct new drug development. In the last couple Healthcare Products Regulatory Agency (MHRA), UK years, several formal consultation meetings have been organized. In this section, speaker from RDPAC will give an overview about their Health Canada's GCP Compliance Program perception on drug regulatory environment in China and speakers Alicja KASINA, PhC, MSc from industry will share cases and experiences on how to work with CDE to conduct formal consultation meetings. Drug Specialist, GCP Compliance Unit, HPFB Inspectorate, Health Canada Perception of RDPAC on Drug Regulatory Environment in China Maggie CHANG SFDA Speaker Invited Director, Drug Regulatory & Medical Affairs, China Association of Enterprises with Foreign Investment, R&D-based Pharmaceutical PANEL DISCUSSION Association Committee (RDPAC), China ADDITIONAL PANELIST: Earl HULIHAN, Professor From Discovery to Marketing Launch, Icotinib's 10 Years Research Principal Associate, EW Hulihan and Associates, Inc., USA and Development in China Yinxiang WANG, PhD CEO & CSO, Zhejiang Beta Pharma Inc., China Session T 1-8 | Wednesday, May 23, 2012 15:30 - 17:00 (1/F, Century Hall) Reﬂection of A Recent Pre-IND(Investigational New Drug) Consultation Meeting with CDE QUALITY MANAGEMENT SYSTEM (QMS), QUALITY BY DESIGN (QBD) AND QUALITY RISK MANAGEMENT (QRM) IN CLINICAL RESEARCH Rochelle KOU, MD Senior Manager, Regulatory Affairs and Medical Affairs, AstraZeneca

SESSION CHAIR , China Helen LI, MD Emerging Market QA Asia Lead, Pfizer Medical Quality Assurance, Session T 2-2 | Tuesday, May 22, 2012 China 10:30-12:00 (3/F, Yellow River Hall) Pharmaceutical companies have started implementing Quality SCIENCE-BASED REGULATORY DECISION-MAKING: REALITY OR Management System and Quality by Design (QbD) and Quality ASPIRATION? — US FDA EXPERIENCE Risk Management (QRM) approach in clinical research. The speakers will introduce the general principles, considerations in SESSION CHAIR GCP and Pharmacovigilance(PV), benefits, and available tools and Zili LI, MD, MPH techniques. Former Medical Team Leader, Office of New Drug Review, Center for Drug Evaluation and Research (CDER), US FDA The Importance of Quality Management System Co-Chair of FDA Alumni Association International Network Deborah DRISCOLL Executive Director, Head of Emerging Market Regulatory Strategy Vice President, Quality Assurance, Medical Division, Pfizer Inc., USA and Liaison, Merck & Co., USA

Quality by Design: Approach Taken to Management of Clinical For the first time, the audience will have the opportunities to hear Quality Assurance Activities in Asia Pacific three former senior officials of the Office of New Drugs, USFDA/ Joanne NORTH CDER to share their personal experience and challenges they faced Director, Asia Pacific Clinical Quality Assurance, Clinical Quality in making tough regulatory decisions. Their perspectives will meld Assurance, Global Quality and Compliance, GSK, UK both their experiences as governmental regulators as well as their subsequent experiences in the pharmaceutical industry. Today, Quality Risk Management: Hype or The New Paradigm? more than ever, the US FDA faces many challenges as science and Beat E. WIDLER, PhD society grows increasingly complex. Transparency is a growing Managing Partner, Widler & Schiemann Ltd., Switzerland expectation and a major initiative at FDA. Nevertheless, industry has often wondered what is on the minds of regulators and how do Q&A they view benefit-risk decision-making. This session will describe principles at play at the US FDA that are also highly relevant to other national regulatory authorities. THEME 2 | REGULATORY AFFAIRS Overview of Regulatory Decision-Making at US FDA : Challenges Met and Unmet Session T 2-1 | Tuesday, May 22, 2012 Florence HOUN, MD, MPH, FACP Former Director, Office of Drug Evaluation III, Center for Drug 8:30 - 10:00 (3/F, Yellow River Hall) Evaluation and Research (CDER), US FDA EXPERIENCE OF CDE SRP FORMAL CONSULTATION Co-Chair of FDA Alumni Association International Network Vice President, Celgene Regulatory Policy and Strategy, USA SESSION CHAIR Ning LI, MD, PhD The CDER Regulatory Briefing - An Innovative Approach to Improve Vice President, GRA Head, Medical Policy, Asia, Sanofi, China Decision-Making Mark J. GOLDBERGER, MD, MPH, FIDSA Former Director, Office of Drug Evaluation IV, Center for Drug

Evaluation and Research (CDER), US FDA SFDA Speaker Invited Member of FDA Alumni Association Vice President, Abbott Regulatory Intelligence and Policy, USA Latest Developments in US FDA Regulation of Drug-Device Combination Products Handling Scientiﬁc Disagreements at FDA Scott DANZIS Robert J. MEYER, MD Partner, Food & Drug and Health Care, Covington & Burling LLP, Former Director, Office of Drug Evaluation II, Center for Drug USA Evaluation and Research (CDER), US FDA Member of FDA Alumni Association Drug/Device Combination Products: Industry Cases Study Vice President, Head of Global Regulatory Strategy, Policy and Jeffrey R. FERGUSON Safety, Merck & Co, Inc., USA Director, Global Regulatory Affairs (CMC), Eli Lilly and Company

PANEL DISCUSSION ADDITIONAL PANELISTS: Session T 2-6 | Wednesday, May 23 2012 Tao WANG, MD, PhD 10:30-12:00 (3/F, Yellow River Hall) Acting Office Director, Clinical Review Office II, Center for Drug PMDA UPDATE -PMDA'S CURRENT STATUS AND FUTURE DIRECTION Evaluation, SFDA, China

Ning LI, MD, PhD SESSION CHAIR Vice President, GRA Head, Medical Policy, Asia, Sanoﬁ, China Toshiyoshi TOMINAGA, PhD David RUSSELL Director, Office of International Programs, PMDA, Japan Chairman & General Manager, Celgene Pharmaceutical (Shanghai) Co. Ltd, China PMDA’s Efforts to strengthen New Drug Review -How we accelerate reviewing speed Norihiko YODA,MD Session T 1-3/T2-3/T3-3 | Tuesday, May 22, 2012 Director, Office of New Drug III, PMDA, Japan 13:30 - 15:00 (7/F, Grandball Room I) PMDA Consultation and its Successful Examples - Sponsor's SFDA/CENTER FOR DRUG EVALUATION (CDE) TOWNHALL Viewpoint Tetsuomi TAKANO • Overall introduction to CDE Senior Director, Head of Asian Development Strategy, Asian • Decision-Making Path for Technical Evaluation Development, Astellas Pharma Global Development, Astellas • Technical Evaluation Guidelines System Pharma Inc., Japan • Hot Topics in Clinical Trial • Clinical Trail Risk Control for Innovative Drug PMDA’s Commitment to Cutting-Edge Technology -Pharmaceutical Affairs Consultation on R&D Strategy Tsuyoshi ANDO, PhD Session T 1-4/2-4/3-4/4-4 | Tuesday, May 22, 2012 Deputy Manager, Pharmaceutical Affairs Consultation Group on 15:30 - 17:30 (7/F, Grandball Room I) R&D Strategy, Office of Review Management, PMDA, Japan SFDA/CENTER FOR DRUG EVALUATION (CDE) TOWNHALL Session 2-7 | Wednesday, May 23 2012 • Overall introduction to CDE 13:30 - 15:00 (3/F, Yellow River Hall) • Decision-Making Path for Technical Evaluation • Technical Evaluation Guidelines System IP PROTECTION IN NEW DRUG DEVELOPMENT • Hot Topics in Clinical Trial SESSION CHAIR • Clinical Trail Risk Control for Innovative Drug Shaoyu CHEN, JD Managing Director, China Food and Drug Practice, Covington & Burling LLP, China Session T 2-5 | Wednesday, May 23, 2012 8:30 - 10:00 (3/F, Yellow River Hall) Intellectual property protection is a critical component of any MEDICAL DEVICES AND COMBINATIONAL PRODUCTS - successful new drug development program. China has been making REGULATORY PROCESS AND PRACTICES steady progress in IP protection recent years, although challenges remain to be overcome. In this session, experts will discuss the latest SESSION CHAIR developments in China’s patent and other IP protection laws, as well Jeffrey R. FERGUSON as offer practical tips on best practices to adopt and pitfalls to avoid Director, Global Regulatory Affairs (CMC), Eli Lilly and Company, in business activities during new drug development. USA IP Due Diligence During Innovative Pharmaceutical Product Licensing This session provides an comprehensive overview of regulatory David SHEN, PhD, JD regulation governing the classiﬁcation, registration, quality control Regional Legal Counsel, AstraZeneca, China and update on the recent trend in Pre-Approval Regulations of medical devices and combinational products. Examples will be Recent Changes of Pharma IP in China introduced to demonstrate the challenges and opportunities in Qingkui ZHANG development of combination products. Director-General, Pharma/Bio Department, State Intellectual Property Office, China China Medical Device Regulatory Framework and Registration Procedures Anti-Counterfeiting Enforcement Strategy in China Amber WANG Zhenghong LUO, JD Director, Regulatory Affairs, Medtronic, China LawJay Partners, China

aspects of CMC strategy. PANEL DISCUSSION ADDITIONAL PANELIST: CMC Strategies and Global Collaborations Chen YANG Scott COFFEY Partner, Head of China Life Sciences, Sidley Austin LLP, China Director, Process Design and Development, Eli Lilly, USA Weishi LI, PhD, JD Suhan TANG, PhD Partner, Bird & Bird Law Firm, Shanghai Office, China Chief Manufacturing Officer, WuxiApptec, China

Regulatory Strategy in CMC Session 2-8 | Wednesday, May 23, 2012 Irene DENG 15:15 - 17:00 (3/F, Yellow River Hall) Head of Regulatory China, Shanghai Roche Pharmaceticals Ltd., China GENERICS - REGULATORY CHALLENGES AND OPPORTUNITIES

SESSION CHAIR Session T 3-2 | Tuesday, May 22, 2012 Shaoyu CHEN, JD Managing Director, China Food and Drug Practice, Covington & 10:30-12:00 (3/F, 3C+D) Burling LLP, China CMC STRATEGIES AND PRACTICES - GMP COMPLIANCE AND QUALITY The total drug applications in 2010 are about 1000 cases and 640 were generic drug applications according to the 2010 Drug SESSION CO-CHAIRS Registration Annual Report issued by SFDA. Although the generic Yi REN, PhD applications already decreased signiﬁcantly, from a long term Senior Director, Head of Chemistry, Manufacturing and Control, point of view, generic applications will still play an important role Roche Research and Development Center, China in China drug registration based on current economy and industry Tony ZHANG, PhD situation. In this session, speakers from domestic and multi-national Vice President, Global External Research and Development, Asia, Eli companies will share experience and cases in related to generic Lilly and Company, China applications/registrations in China, as well as challenges and opportunities in the next few years. GMP Compliance in China Legal and Regulatory Requirements in US FDA Generic Drug Steven WOLFGANG, PhD Approval Mechanism and Its Reference Value for China and India Acting Associate Director, Risk Science, Intelligence, and Prioritization, Center for Drug Evaluation and Research (CDER), Shaoyu CHEN, JD Office of Compliance, Office of Drug Security, Integrity and Recalls, Managing Director, China Food and Drug Practice, Covington & US FDA, USA Burling LLP, China GMP in Emerging Markets and Developed Markets Creative Thinking in Generic Drug: New Consideration for Generic Drug Development and Registration Jifeng LEI, MS, MBA CEO, Shanghai Anbison Lab Co., Ltd., China Xiangyang XU, PhD Vice President and Head of Generics Drug Development, Simcere PANEL DISCUSSION Research & Development Center, China Session T 1-3/T2-3/T3-3 | Tuesday, May 22, 2012 Authorized Generics - A New Opportunity for Indian Pharma Companies 13:30 - 15:00 (7/F, Grandball Room I) Udupa N., Professor Department of Pharmacy Management, Manipal College of SFDA/CENTER FOR DRUG EVALUATION (CDE) TOWNHALL Pharmaceutical Sciences, Manipal University, India • Overall introduction to CDE • Decision-Making Path for Technical Evaluation THEME 3 | CMC/GMP • Technical Evaluation Guidelines System • Hot Topics in Clinical Trial • Clinical Trail Risk Control for Innovative Drug Session T 3-1 | Tuesday, May 22, 2012 8:30 - 10:00 (3/F, 3C+D) CMC STRATEGIES AND PRACTICES Session T 1-4/2-4/3-4/4-4 | Tuesday, May 22, 2012 15:30 - 17:30 (7/F, Grandball Room I) SESSION CO-CHAIRS SFDA/CENTER FOR DRUG EVALUATION (CDE) TOWNHALL Yi REN, PhD Senior Director, Head of Chemistry, Manufacturing and Control, • Overall introduction to CDE Roche Research and Development Center, China • Decision-Making Path for Technical Evaluation Tony ZHANG, PhD • Technical Evaluation Guidelines System Vice President, Global External Research and Development, Asia, Eli • Hot Topics in Clinical Trial Lilly and Company, China • Clinical Trail Risk Control for Innovative Drug CMC is an import part of drug development, for both new and generic drugs. Having the correct strategy for CMC not only will Session T 3-5 | Wednesday, May 23, 2012 enhance the chance of fast regulatory approval of the marketing application of the drug, ensure the high and consistent quality of 8:30 - 10:00 (3/F, 3C+D) the drug during manufacturing and distribution, but also will allow CMC FOR DRUG PRODUCTS the drug developer to get the best cost beneﬁt. In this session we will hear from both industry and regulatory agency on certain key SESSION CO-CHAIRS

Ling YE, PhD quality by design (QbD) and product lifecycle concepts. The principles Associate Director, Analytical Research and Development, Shanghai in Q11, which covers both chemical entities and biotech products, will Johnson & Johnson Pharmaceuticals, China be presented. An overview of the ICH guidelines Q5E, “Comparability Yi REN, PhD of Biotechnological/Biological Products Subject to Changes in Their Senior Director, Head of Chemistry, Manufacturing and Control, Manufacturing Process” will be provided with case studies. The Roche Research and Development Center, China scientific thinking behind ICH Q1D, “Bracketing and Matrixing Designs for Stability Testing” and ICH Q1E, “Evaluation of Stability Data” and In this session we have esteemed experts to discuss the execution the implementation of these guidelines will be discussed. of the CMC strategy, from formulation development to final stability testing of the product. This session is targeted to provide practical New ICH Guideline Q11: “Development and Manufacture of Drug know hows on different stages and aspects of the drug product Substances” development. A panel discussion is scheduled at the end of this Patrick SWANN, PhD morning’s presentations for all the questions to all the presenters. Deputy Director, Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), US FDA Bio Availability and Bio Equivalency US FDA Representative on ICH Q11 Expert Working Group, USA Dale CONNER, PhD Director, Division of Bioequivalence I, Office of Generic Drugs ICH Guideline Q5E, “Comparability of Biotechnological/Biological (OGD), Center for Drug Evaluation and Research (CDER), US FDA, Products Subject to Changes in Their Manufacturing Process” and USA Its Implementation Duu-Gong WU, PhD Formulation Development for Generic Drugs Executive Director, PharmaNet, USA Chao YE, PhD Former Deputy Division Director, Office of New Drug Quality Associate Director, Research and Development, OTC, Asia Pacific, Assessment, Center for Drug Evaluation and Research (CDER), US Johnson & Johnson, China FDA Former US FDA Representative on ICH Q5E Expert Working Group

Session T 3-6 | Wednesday, May 23, 2012 Session T 3-8 | Wednesday, May 23, 2012 10:30-12:00 (3/F, 3C+D) 15:30 - 17:00 (3/F, 3C+D) CMC FOR DRUG PRODUCTS IMPLEMENTATION OF NEW AND OTHER ICH QUALITY GUIDELINES SESSION CO-CHAIRS SESSION CHAIR Ling YE, PhD Associate Director, Analytical Research and Development, Shanghai Chi-Wan CHEN, PhD Johnson & Johnson Pharmaceuticals, China Executive Director, Global CMC, Pﬁzer Inc. Former Deputy Director, Office of New Drug Quality Assessment, Yi REN, PhD Center for Drug Evaluation and Research (CDER), US FDA Senior Director, Head of Chemistry, Manufacturing and Control, Member of US FDA Alumni Association International Network, USA Roche Research and Development Center, China ICH Guidelines Q1D, “Bracketing and Matrixing Designs for Stability Packaging Consideration (Labeling, Shipping, Distribution, Testing of New Drug Substances and Products,” and Q1E, “Evaluation Logistics) of Stability Data” and Their Implementation Mark PLEZIA David LIN, PhD Associate Director, R&D Pharmaceutical Packaging Technologies, Senior Consultant, Biologics Consulting Group, USA McNeil Consumer Healthcare, Johnson & Johnson, USA Former Acting Division Director, Office of New Drug Quality Assessment, Center for Drug Evaluation and Research (CDER), US Strategy for Stability Testing FDA Joan RUAN, PhD Chair of Former US FDA CDER Stability Technical Committee Associate Director, Analytical Development, Bristol-Myers Squibb, FDA CDER QbD Pilot Program for Biotech Products USA Patrick SWANN, PhD Deputy Director, Office of Biotechnology Products, Center for Drug Technology and Method Transfer Evaluation and Research (CDER), US FDA, USA KIM Huynh-Ba Director, Pharmacopeial Education, US Pharmacopeia, USA PANEL DISCUSSION

PANEL DISCUSSION THEME 4 | STATISTICS Session T 3-7 | Wednesday, May 23, 2012 13:30 - 15:00 (3/F, 3C+D) Session T 4-1 | Tuesday, May 22, 2012 IMPLEMENTATION OF NEW AND OTHER ICH QUALITY GUIDELINES 8:30 - 10:00 (5/F, Yangtze River Hall) NON-INFERIORITY TRIAL GUIDANCE AND ADAPTIVE DESIGN SESSION CHAIR GUIDANCE Chi-Wan CHEN, PhD

Executive Director, Global CMC, Pﬁzer Inc. SESSION CO-CHAIRS Former Deputy Director, Office of New Drug Quality Assessment, William WANG, PhD Center for Drug Evaluation and Research (CDER), US FDA Head of Asia Paciﬁc Hub, Biostatistics and Research Decision Member of US FDA Alumni Association International Network, USA Sciences (BARDS), Merck Research Laboratories, Merck & Co., Inc, China The ICH Q11, “Development and Manufacture of Drug Substances” is the latest in a series of ICH quality guidelines which are based on the Weiying YUAN, PhD

Site Head of Biostatistics and Programming, Pharmaceutical in modern drug research and development (Research and Research and Development, Johnson & Johnson, China Development). This includes microarray expression profiling, genomewide screening, and the recent advances in next generation The session will provide some updates to the draft guidance. Cases sequencing. The high-throughput based biomarker research has studies on non-inferiority clinical trials will be presented with some the potential to enable pharmaceutical companies to discover technical and research discussion. The session will also present therapeutic compounds based on the proteins, enzymes, and industry survey results on adaptive design practices experiences RNA molecules that are either associated with disease through and hurdles, to be followed by regulatory commentary and a panel patients’ genomics or proteomics characteristics or acted as a discussion including non-inferiority and adaptive design topics. drug target. In this session, clinical and scientific researchers from both academics and industry will present high-throughput based Update of the Non-inferiority Draft Guidance biomarker developments and their applications in drug Research Hsien-Ming James HUNG, PhD and Development. Director, Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA Sequencing, Sequencing and Sequencing Lara GONG, PhD A Statistical Consensus about NI Trials for NDAs in China -- On Head of Pharmacogenomics Division, BGI, China Behalf of China Clinical Trial Statistics Working Group Jielai XIA, Professor Genomic RNAi for Drug Development 4th Military Medical University, External Statistical Reviewer of CDE Douglas ZHANG, PhD of SFDA, China Head of Early Development Statistics, Asia Pacific, Merck Research Laboratories, China DIA Adaptive Design Survey Nitin PATEL, PhD Proteomics and Metabolomics for Biomarker Discovery and Drug Chairman and Chief Technology Officer, Cytel, Inc., USA Development Toshiyuki MIKAMI, PhD Specialist in Proteomics and Metabolomics, Genomic Science Session T 4-2 | Tuesday, May 22, 2012 Laboratories, Danippon Sumitomo Pharma Co., Ltd., Japan 10:30-12:00 (5/F, Yangtze River Hall) NON-INFERIORITY TRIAL GUIDANCE AND ADAPTIVE DESIGN Session T 1-4/2-4/3-4/4-4 | Tuesday, May 22, 2012 GUIDANCE 15:30 - 17:30 (7/F, Grandball Room I) SESSION CO-CHAIRS SFDA/CENTER FOR DRUG EVALUATION (CDE) TOWNHALL William WANG, PhD Head of Asia Pacific Hub, Biostatistics and Research Decision • Overall introduction to CDE Sciences (BARDS), Merck Research Laboratories, Merck & Co., Inc, • Decision-Making Path for Technical Evaluation China • Technical Evaluation Guidelines System Weiying YUAN, PhD • Hot Topics in Clinical Trial Site Head of Biostatistics and Programming, Pharmaceutical • Clinical Trail Risk Control for Innovative Drug Research and Development, Johnson & Johnson, China

Commentary on DIA Adaptive Design Survey Session T 4-5 | Wednesday, May 23, 2012 Sue-Jane WANG, PhD Associate Director, Pharmacogenomics and Adaptive Design, Office 8:30 - 10:00 (5/F, Yangtze River Hall) of Biostatistics, Office of Translational Sciences, Center for Drug DESIGN AND ANALYSIS OF PROOF-OF-CONCEPT AND DOSE- Evaluation and Research, US FDA FINDING STUDIES IN DRUG DEVELOPMENT

PANEL DISCUSSION SESSION CO-CHAIRS PANELISTS: Roger QU, PhD All Speakers in Sessions 1 & 2 Senior Director, Clinical Statistics, Pﬁzer (China) Research and Irving HWANG, PhD Development Center, China President, Irving Consulting Group (ICG), USA Robert LUO, PhD SFDA Panelist Invited Director, Clinical Statistics, Pﬁzer (China) Research and Development Center, China

Session T 4-3 | Tuesday, May 22, 2012 Clinical development is a costly and long process. Properly identifying promising regimen for late stage clinical development is 13:30 - 15:00 (5/F, Yangtze River Hall) critical to the success of clinical programs, and can bring to patients HIGH THROUGHPUT BASED QUANTITATIVE BIOMARKER the right treatment in the most efficient way. This becomes even DEVELOPMENT FOR DRUG RESEARCH AND DEVELOPMENT more important with the rising cost for drug development and high expectation for new and better treatment. SESSION CO-CHAIRS This session features the design and analysis of early phase clinical Sue-Jane WANG, PhD studies and model-based approach for dose selection for future Associate Director, Pharmacogenomics and Adaptive Design, Office clinical trials. of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), US FDA A Proof-of-Concept Clinical Trial Design Combined with Dose Douglas ZHANG, PhD Ranging Exploration Head of Early Development Statistics, Asia Paciﬁc, Merck Research Naitee TING, PhD Laboratories, China Senior Principal Statistician, Biometrics Group, Boehringer- Ingelheim Pharmaceuticals Inc., USA The high-throughput biotechnologies play an important role

Dose Selection Based on Interim Analysis - a Real Case Study Pharmacovigilance has become a more proactive process and Bob YAN, PhD, MBA has expanded considerably beyond just identifying adverse Director, Biostatistics and Data Sciences, Asia Pacific, Parexel, China events. What is a ‘signal’? CIOMS VIII (2010) defines a signal as, “Information that arises from one or multiple sources which Application of Modeling and Simulation in Design of Clinical Trials suggests a new, potentially causal association, or a new aspect of a Rujia XIE, PhD known association between an intervention and an event or set of Associate Director, Clinical Pharmacology & Pharmacometrics, related events, either adverse or beneficial, that is judged to be of Pfizer (China) Research and Development Center, China sufficient likelihood to justify verification action.” Signal detection is defined as an “…act of looking for and/or identifying signals using Q&A event data from any source”. This act is an important component of a much larger process - signal management, which comprises also signal prioritization and signal evaluation. Theme 5 | Drug Safety This session aims to provide you with grounded theories, practical aspects, and current development of signal management, and its role in evolving safety risk management. Session T 5-1 | Tuesday, May 22, 2012 Methods for Signal Detection, Illustrated With a Recent Case Study 8:30 - 10:00 (5/F, 5D+E) Robert MAKUCH, PhD, Professor PHARMACOVIGILANCE (PV) ASPECT OF DUE DILIGENCE AND Director of the Regulatory Affairs Track, Yale University, USA LICENSING AGREEMENT Former Head of Biostatistics, School of Public Health, Yale University, USA SESSION CHAIR Lin CONG Overview of Safety Signal Management Process (Signal Detection, Director, US DSU Team Lead, Safety Evaluation & Reporting, Signal Prioritization, and Signal Evaluation) Worldwide Safety & Regulatory Operations, Pfizer (China) Research Craig HARTFORD, MD, MSc Med, PhD and Development Co., Ltd., China Vice President, Safety Surveillance and Risk Management (SSRM), Worldwide Safety Strategy (WSS), Worldwide Research & At the global level, partnership between pharmaceutical companies Development (WRD), Pfizer, UK to co-develop and/or co-market products has become increasingly common and more complex in recent years. In the Chinese market, From Signal Detection to Signal Refinement there are also increasing partnership between international and K. Arnold CHAN, MD, ScD, FISPE domestic companies. Prior to the finalization of the licensing agreement, to have an integrated risk assessment of the licensing Chief Scientist, Epidemiology, Life Sciences, OptumInsight opportunity, it is crucial for parties subject to licensing agreements Principal Epidemiologist, Department of Epidemiology, School of to fully assess the safety profile of the licensed product as well as Public Health, Harvard University, USA the other party’s pharmacovigilance system. Due to the stringently regulated environment on pharmacovigilance, all parties also need Introduction to EMA Guideline on Signal Detection and New EU to be fully aware of and compliant with global regulatory safety Initiatives reporting and other pharmacovigilance requirements. This session Martin VOTAVA, MD, PhD provides an overview of models and processes of pharmacovigilance Director, Regulatory Science, PharmInvent, Czech Republic due diligence and the legal perspective as well as global regulatory Former Member of the Committee for Medicinal Products for requirements on pharmacovigilance agreements. Human Use CHMP, EMA

Pharmacovigilance Agreements (PVAs) - Legal Perspective and Regulatory Requirements THEME 6 | CRO DEVELOPMENT Maria Grazia ZURLO, MD Vice President, EU PV Qualified Person, Pfizer, Italy Session T 6-1 | Tuesday, May 22, 2012 Models and Processes of Pharmacovigilance Due Diligence: From 8:30 - 10:00 (5/F, 5B+C) Product Safety to PV System CRO DEVELOPMENT IN CHINA Joy LI, MD, PhD Director, Pharmacovigilance & Medical Information, China R&D, SESSION CO-CHAIRS Bristol-Myers Squibb (China) Investment Co., Ltd., China Honggang BI, PhD Corporate Vice President, General Manager China, Covance, China Challenges in Managing Generic Product PVAs in Emerging Markets Yanhua GONG Lynn Zhou, MD Vice President & Secretary General of CROU (CRO Union), China International PV Coordinator, PV Affiliate Relations, Global Association for Pharmaceutical and Medical Technology Exchange, Pharmacovigilance&Epidemiology, Sanofi, China China

The CRO industry in China continued its growth trend in the past Session 5-2 | Tuesday, May 22, 2012 few years. This is evidenced by growing number of organizations, 10:30-12:00 (5/F, 5D+E) abundance and quality of the talent, experience in project execution SIGNAL DETECTION IN A NEW ERA and overall quality of the project conduct. We have seen growth in China for both local and global CROs and the maturation of SESSION CHAIR the industry will ensure the overall success of drug development projects in China. Vera LIANG, MD Director, Associate Safety Risk Lead, Safety Surveillance and Risk This session will discuss the growth trend for global and local CROs Management, Worldwide Safety Strategy, Pﬁzer (China) Research in China: and Development Co., Ltd., China • Industry overview and history. • Evolution from functional to full service, from trials with narrow

focuses to trials with broader implications including parallel The Changing Clinical Pharmacology Landscape: Perspective from global drug development. A Global CRO • Challenges for global and local CROs: regulatory environment, Robert Allen ASPBURY talent development, quality management, site management Global Vice President and General Manager, Clinical Pharmacology and relationship management between CRO and sponsors, Services, Covance Inc., USA case studies will be reviewed. First In Human Study in China - Opportunity and Challenges • Increasing role of local global CROs for clinical development in China, how does the local presence and operation knowledge Jack XU, MD, MS contribute to the success of clinical development projects in Senior Vice President, Shanghai Clinical Research Center, China China. New Technologies in China - As eClinical Platforms Develop What Quality: An Essential and Critical Component of CRO Services - Does the Future Hold for CROs in China? Quality, Strategy, System and Delivery Rob NICHOLS, MS Honggang BI, PhD Senior Director, Global CRO Partnerships, Oracle Corporation, UK Corporate Vice President, General Manager China, Covance, China PANEL DISCUSSION CRO’s Business Growth and Development in China - International CRO Perspectives Yanbin XIE THEME 7 | VACCINE AND BIOLOGICS General Director, ICON, China

Engaging CRO in Clinical Development in China - Local CRO Session T 7-1 | Tuesday, May 22, 2012 Perspectives 13:30 - 15:00 (5/F, 5D+E) Wen CHEN, MBA VACCINE AND BIOLOGICS DEVELOPMENT AND INNOVATION- PART I Vice President, Business Development, Tigermed Consulting Co. Ltd., China SESSION CHAIR Xuefeng YU, PhD International Sponsor's View on China CROs CEO, Tianjin CanSino Biotechnology Inc., China Mariano M. YOUNG, Jr., MD Chair of China Branch, Canadian Chinese Biomedical and Director, Vaccine Clinical Research, Pﬁzer, China Pharmaceutical Association

Local Sponsor’s View on China CROs Helen JIANG, MD, PhD Drug Regulation Involving Biologics and New Directions at the FDA: Executive Medical Director, Jiangsu Hengrui Medicine Co., Ltd., FDA Clinical Risk Assessment China William SCHWIETERMAN, MD Chief Medical Officer, Chelsea Pharmaceuticals, USA Former Chief of Immunology and Infectious Disease, Division of Session T 6-2 | Tuesday, May 22, 2012 Clinical Trial Design and Analysis, Center for Biologics, US FDA 10:30-12:00 (5/F, 5B+C) EARLY CLINICAL RESEARCH CRO INCLUDING CLINICAL Experience of working with CROs in vaccine development: MNC PHARMACOLOGY, E-TECHNOLOGY IN CLINICAL RESEARCH - company perspective. CHALLENGES AND OPPORTUNITIES IN CHINA Mariano M. YOUNG, Jr., MD Director, Vaccine Clinical Research, Pﬁzer, China SESSION CO-CHAIRS Honggang BI, PhD The EU Approach to Regulating Gene- and Cell-based Therapies Corporate Vice President, General Manager China, Covance, China Stephan JEPARDS Yanhua GONG Drug Research, Drug Regulatory Affairs, University of Bonn, Vice President & Secretary General of CROU (CRO Union), China Germany Association for Pharmaceutical and Medical Technology Exchange, China Session T 7-2 | Tuesday, May 22, 2012 The landscape for early clinical research has changed over the last 15:30 - 17:00 (5/F, 5D+E) few years. Whilst the focus is still on determining safety and earlier VACCINE AND BIOLOGICS DEVELOPMENT AND INNOVATION- PART II signal for efficacy for new investigational compounds, the need for speed and efficiency to support faster "go, no-go" decisions has SESSION CHAIR become a very high priority. Xuefeng YU, PhD The session will focus on the following subjects CEO, Tianjin CanSino Biotechnology Inc., China Chair of China Branch, Canadian Chinese Biomedical and • Current global trend of early clinical research including Pharmaceutical Association clinical pharmacology - Combination or "hybrid" protocol designs, Phase I in patients, complex experimental models and Biosimilars: Latest Developments in US FDA Regulation of regulatory environment changes. Biosimilars • Clinical pharmacology especially ﬁrst in human studies in China Scott CUNNINGHAM - History, current status and future development; challenges Partner, Food and Drug Practice Group, Covington & Burling LLP., and opportunities, case studies. USA • E-Technology application in clinical research - EDC application development and trends, impact to CROs and sponsors, Xuefeng YU, PhD challenges and opportunities in China. CEO, Tianjin CanSino Biotechnology Inc., China Chair of China Branch, Canadian Chinese Biomedical and

Pharmaceutical Association US Regulatory Principles on Vaccine Development and Approval Sara E. GAGNETEN, PhD Biosimiliar and Innovative Vaccine and Biologics Development Regulatory Scientist, Center of Biologics Evaluation and Research Michel MIKHAIL, PhD (CBER), Office of Vaccines Review and Research (OVRR), US FDA, Chief Regulatory Officer & Executive Vice President, Global USA Regulatory Affairs, Fresenius Kabi, Germany The criticality of the safety assessment in the Vaccine submission process in China Session T 7-3 | Wednesday, May 23, 2012 Jing MA, PhD 8:30 - 10:00 (5/F, 5D+E) President, National Shanghai Center for New Drug Safety Evaluation VACCINE DEVELOPMENT AND APPROVAL FOR UNMET NEEDS and Research, China

SESSION CHAIR Cancer Vaccines and Novel Adjuvant Development Florence HOUN, MD, MPH, FACP Sara E. GAGNETEN, PhD Former Deputy Director, Center of Biologics Evaluation and Regulatory Scientist, Center of Biologics Evaluation and Research Research (CBER), Office of Vaccines Review and Research (OVRR), (CBER), Office of Vaccines Review and Research (OVRR), US FDA, US FDA USA Co-Chair of FDA Alumni Association International Network Vice President, Celgene Regulatory Policy and Strategy, USA Session T 7-5 | Wednesday, May 23, 2012 Every year from 250,000 to 500,000 people die from seasonal 13:30 - 15:00 (5/F, 5D+E) influenza. In a global pandemic, the death toll could be millions. MONOCLONAL ANTIBODY AND CELL THERAPY DEVELOPMENT In 2009 the world had a wake-up call with a nonlethal pandemic, AND INNOVATION - PART I the H1N1 2009 pandemic influenza virus. In 2009, the Chinese manufacturer Sinovac was the first company to have an approved SESSION CHAIR H1N1 vaccine to combat this threat. It is important to recap the lessons learned from that episode and to present new developments Zeling CAI, PhD and policies that industry and regulatory agencies are using to Senior Vice President, Shanghai Celgen Biopharmaceutical Co. Ltd., hasten influenza vaccine production, once a pandemic strain is China isolated. Important topics include vaccine schedule testing for pediatrics and the elderly, new adjuvants, and new technologies Biological product development and therapy have become a very beyond Embryonic egg-based manufacturing platforms. important and novel approach in improving medical treatment. In addition to the success in monoclonal antibody treatment Unlike preventive vaccines, therapeutic cancer vaccines trigger development, cell therapies have been showing promising. This the immune system to recognize and destroy cancer cells already session will have world experts and leaders from industry and present in the body. Recent advances in tumor immunology are academy to share their consideration and progress in monoclonal the basis for promising clinical studies of peptide-based therapeutic antibody and cell therapy development including the achievement, vaccines and adoptive immunotherapies to combat cancer. How status, trend, collaboration and innovation. vaccines may help combat cancer and how they are regulated will be discussed as this new therapeutic options gain interest and Protein Therapy Targeting Th17 Pathway for Autoimmune approvals. Inflammatory Diseases Hongtao LU, PhD Challenges & Progress in Approval for Influenza and Other Vaccines Head & Senior Director, Neuroimmunology DPU, GSK R&D, China in China SFDA Speaker Invited Engineering Next-generation Monoclonal Antibody Therapies for Oncology and Autoimmune Disease Manufacturing Advances in Influenza Vaccine Production Bassil DAHIYAT, PhD Zhiping YE, MD, PhD CEO, Xencor, USA Senior Investigator, Division of Viral Products (DVP), Office of Vaccines Review and Research (OVRR), Center of Biologics Biosimilar Mab and Recombinant Protein Development Evaluation and Research (CBER), US FDA, USA Zeling CAI, PhD Senior Vice President, Shanghai Celgen Biopharmaceutical Co., The Chinese Industry Perspective on the 2009 H1N1 Influenza China Vaccine Manufacturing: Preparing for the Future Weining MENG, PhD Senior Manager, International Marketing, International Business Session T 7-6 | Wednesday, May 23, 2012 Department, Sinovac Biotech Co., Ltd., China 15:30 - 17:00 (5/F, 5D+E) MONOCLONAL ANTIBODY AND CELL THERAPY DEVELOPMENT Session T 7-4 | Wednesday, May 23, 2012 AND INNOVATION - PART II 10:30-12:00 (5/F, 5D+E) SESSION CHAIR VACCINE DEVELOPMENT AND APPROVAL FOR UNMET NEEDS Zeling CAI, PhD Senior Vice President, Shanghai Celgen Biopharmaceutical Co. Ltd., SESSION CHAIR China Florence HOUN, MD, MPH, FACP Former Deputy Director, Center of Biologics Evaluation and CIK Therapy for Cancer Research (CBER), Office of Vaccines Review and Research (OVRR), Yi ZHANG, MD, PhD US FDA Director, Biotherapy Center, Distinguished Professor of the Co-Chair of FDA Alumni Association International Network Department of Oncology, the First Affiliated Hospital of Zhengzhou Vice President, Celgene Regulatory Policy and Strategy, USA University, China

Antibody-Cytokine Complexes Shenzhen High-Tech Park's Opportunities and Challenges for Charlie SURH, PhD Entrepreneurs Professor and Member, The Scripps Research Institute, USA Xianping LU, PhD Co-Founder, Member of the Board of Directors, President, and Chief Strategies for Personalized Cell Therapy of Cancer and the Related Scientiﬁc Officer, Chipscreen Biosciences, Ltd., Shenzhen, China Idea for the Practice Guideline of Relative Policies Jin GAO, MD, PhD Yuwen LIU Chairman, Beijing Jing-Meng Stem Cell Technology Co., Ltd., China CEO, Suzhou Biobay, China

QB3: Fostering the Growth of a Life Sciences Innovation Ecosystem THEME 8 | HIGH-TECH PARKS AND INNOVATIVE Kenneth HARRISON, PhD RESEARCH AND DEVELOPMENT: HOW TO INNOVATE Program Manager, Entrepreneurship QB3, BioSF, USA THE BUSINESS MODEL PANEL DISCUSSION

Session T 8-1 | Tuesday, May 22, 2012 THEME 9 | TRANSLATIONAL MEDICINE 13:30 - 15:00 (5/F, 5B+C) WHAT WE'VE AND CAN LEARN FROM - ENTREPRENEUR'S EXPERIENCE, CHALLENGES, AND PERSPECTIVES Session T 9-1 | Wednesday, May 23, 2012 8:30 - 10:00 (5/F, 5B+C) SESSION CO-CHAIRS Peng WANG, PhD TRANSLATIONAL SCIENCE AND PERSONALIZED MEDICINE Vice President, Chief Scientific Officer, Simcere Pharmaceutical SESSION CHAIR Group, China Kewen JIN, PhD Frank JIANG, MD, PhD Managing Partner, Wen Associate, China Vice President, Global Research and Development and Head of Asia Pacific Research and Development, Sanofi, China Donglei MAO Senior Reporter, Medicine Economic News SFDA Southern Medicine Despite significant advances in understanding the molecular Economic Research Institute, China pathogenesis of diseases, translation of basic biomedical research into safe and effective clinical applications remains a failure-prone More and more overseas returnees come to High-Tech Parks across endeavor. This “gap” between discovery research and clinical China to be entrepreneurs for innovative new drug research and benefit illustrates the complexity of human biology. This track will development. focus on key issues relevant to disruptive translational innovation What could be contributed more and better by High-Tech Parks in therapeutics development and to catalyze the generation of and collaboration with local governments? What could be improved novel approaches that will enhance the efficiency of knowledge from returnee entrepreneurs’ perspective? The successes and translation from bench to bedside and back: challenges from biotech companies and experience with IND filing • Addressing the bottlenecks. will be discussed. • Challenging the status quo. • Government-academia-industry partnership. Current Status Analysis • Personalized medicine. Peng WANG, PhD • Biomarker development & validation. Vice President, Chief Scientific Officer, Simcere Pharmaceutical Group, China What Has Gone Wrong with Pharma R&D? Frank JIANG, MD, PhD High-Tech Park Development and Experience Vice President, Global Research and Development and Head of Asia Xiaoou DONG Pacific Research and Development, Sanofi, China Special Advisor to Benxi Municipal Government, Liaoning Province, China Translational Science Moving beyond Slogans and Rhetoric May WANG, PhD Entrepreneur Perspectives Vice President and Head of Translational Science, Hutchison Medi Shawn QIAN, PhD Pharma, China President & CEO, NeuPharma Co., Ltd., China Incorporate Translational Medicine into Innovative Drug R&D Jingsong WANG, PhD Session T 8-2 | Tuesday, May 22, 2012 Head of China Research and Development and Translational 15:30 - 17:00 (5/F, 5B+C) Medicine, Asia Pacific, Sanofi, China CASE STUDIES AND PANEL DISCUSSION Translational Medicine in Practice: Working across Organizational SESSION CO-CHAIRS Divide to Bridge Discovery and Development Peng WANG, PhD Hong I. WAN, PhD Vice President, Chief Scientific Officer, Simcere Pharmaceutical Director, Translational Medicine and Molecular Medicine, Pfizer Group, China BioTherapeutics, USA Kewen JIN, PhD Managing Parner, Wen Associate, China Donglei MAO Senior Reporter, Medicine Economic News SFDA Southern Medicine Economic Research Institute, China

Bridging the Gaps between Clinical Data Management and Clinical Session T 9-2 | Wednesday, May 23, 2012 Operations: Where Do CDMs and CRAs Intersect? 10:30-12:00 (5/F, 5B+C) Shu ZHANG Clinical Trial Operation Manager, Sanoﬁ, China TRANSLATIONAL SCIENCE AND PERSONALIZED MEDICINE: CASE STUDIES AND PANEL DISCUSSION Technology and Process Innovations in Clinical Trial

SESSION CHAIR Susant MALLICK, MBA Head of Clinical Analytics Center of Excellence, Cognizant May WANG, PhD Technology Solutions, India Vice President and Head of Translational Science, Hutchison Medi Pharma, China How to Obtain Timely and Coherent Access to Medical Information Henrik Nørgaard RASMUSSEN, PhD PANEL DISCUSSION Senior Consultant, NNIT Management Consulting, Denmark

Electronic Data Capture: Challenges and Opportunities in China THEME 10 | DATA MANAGEMENT Gaoqiang XIE, PhD, Associate Professor Director, Department of Data Management, Peking University Clinical Research Institute, Medidata Center of Clinical Research Session T 10-1 | Wednesday, May 23, 2012 Technologies, Peking University, China 10:30-12:00 (5/F, Yangtze River Hall) REGULATORY GUIDELINES AND INTERNATIONAL DATA STANDARDS - DATA MANAGEMENT IN CLINICAL STUDIES Session T 10-3 | Wednesday, May 23, 2012 15:30 - 17:00 (5/F, Yangtze River Hall) SESSION CHAIR FACING THE DATA MANAGEMENT CHALLENGE: CASE STUDIES Daniel LIU, PhD Director, China Development, Medidata Solutions Worldwide, China SESSION CO-CHAIRS Anita SHEN • Compare Global Standard and Differences on the Data Quality Certificated Clinical Data Manager, Master of Science New York and Integrity of Clinical Studies in US, EMA and China. University, USA, Head of Wuhan Clinical Data Services Pfizer • Understand Importance of Data Management in The Quality (Wuhan) Research and Development Co., China Assurance of Data Outcomes and Reports in The View of Regulatory Standpoints. Charles YAN, PhD • Harmonize the Global Data Standard to Enhance DM Technical Operations Lead, Clinical Data Service, Pfizer (China) Accountability. Research and Development Co., Ltd., China After the session, the participants learn US FDA regulation and new guideline related to data management of clinical studies, familiar Data managers are facing increased challenges in clinical trials. The with EMA regulation and practices related to data management of case study for data management for a phase I study will provide clinical studies, learn China SFDA guideline and expectation on the an opportunity for audience to gain more experiences on data data accountability collection, edit check and data cleaning process, to learn differences of drug exploration in phase I study designs, and to keep the primary Electronic Source Documentation in Clinical Investigation end point from statistical analysis plan (SAP) in mind when they conduct clinical data management activities. Byungja MARCIANTE Investigator, US FDA Shanghai Office, China This session will also provide a better understanding of CRF design and database setup, CTCAE and RECIST guidelines, TNM staging EMA Standards for Data Management in Clinical Trials system, and special data collecting modules. Vincent YEUNG, PhD, MBA Case Study I: Data Management for Phase I Study GCP Operations Manager and Senior GCP Inspector, Medicine and Healthcare Products Regulatory Agency (MHRA), UK Anita SHEN Certificated Clinical Data Manager, Head of Wuhan Clinical Data SFDA Standards for Data Management in Clinical Trials Services Pfizer (Wuhan) Research and Development Co., China SFDA Speaker Invited Case Study II: Data Management for Oncology Study PANEL DISCUSSION Yufeng CHEN, PhD Clinical Data Manager, Clinical Data Management Group, Medical Data Services Department, Nippon Boehringer Ingelheim Co., Ltd., Session T 10-2 | Wednesday, May 23, 2012 Japan 13:30 - 15:00 (5/F, Yangtze River Hall) DATA QUALITY - IMPROVEMENT OF INTERACTIONS BETWEEN THEME 11 | MEDICAL AND SCIENTIFIC AFFAIRS INDUSTRY AND INVESTIGATIONAL SITES

SESSION CHAIR Session T 11-1 | Wednesday, May 23, 2012 Joanne LIU 13:30 - 15:00 (5/F, 5B+C) Regional Director, Asia Paciﬁc Data Management Center, Global Data Management & Standards, Merck & Co. Inc, China MEDICAL LEADERSHIP IN A DYNAMIC ENVIRONMENT

SESSION CHAIR A closer interaction between sponsor, vendor and investigational sites are critical to the success of a clinical trial. This session will Bing YAN, MD, MBA discuss different approaches to improve the interactions between Head of Clinical Development Asia & China Vaccines Lead, Emerging industry and sites, and the success of each approach. Markets, Pﬁzer Inc., China

In this session, presenters will discuss and share experience how increasingly medical affairs is exhibiting its strategic leadership in pharmaceutical business through its role in various aspects, e.g., clinical & outcomes research, treatment guideline development, use of real world data, medical knowledge and insights management, etc.

Scientiﬁc Leadership - A Key Focus of Medical Affairs Professionals Frank Fan, PhD Senior Medical Director, Sanoﬁ, China

Medical Planning in New Product Launch and Life Cycle Management - Addressing the Unmet Medical Needs Wei YU Associate Medical Director, Medical Affairs, Medical, Pﬁzer Biopharmaceuticals, China

Role of Registries and Outcomes Research - Providing Value Added Approaches to Market Access Gemma ZHU HEOR (Health Economics and Outcomes Research) Manager, Bayer Healthcare, China

Session T 11-2 | Wednesday, May 23, 2012 15:30 - 17:00 (5/F, 5B+C) ROUNDTABLE DISCUSSION: MEDICAL AFFAIRS VS. CLINICAL DEVELOPMENT, IS IT A REALITY OR ASPIRATION?

SESSION CHAIR Bing YAN, MD, MBA Head of Clinical Development Asia & China Vaccines Lead, Emerging Markets, Pﬁzer Inc., China Frank FAN, PhD Senior Medical Director, Sanoﬁ, China

The medical affairs function at the pharmaceutical companies is evolving beyond its traditional support function into a matrix of major responsibilities bridging research, clinical development, scientiﬁc publications, health outcomes, biostatistics, medical education and diverse other medical services. To fulﬁll the requirements of its growing strategic role, the Medical Affairs function needs to continuously re-invent itself by optimizing its overall capabilities. This is a round table interactive discussion session. A group of senior medical affairs leaders will share their experience and expertise and engage an in-depth debate/discussion with the participating audience the role of medical affairs in clinical research arena at various stages of new drug development, pre- and post- drug approval, and its potential impact throughout the organization.

ROUNDTABLE PANELISTS: Xiaoxiang CHEN, PhD Vice President, Medical, Boehringer Igelheim, China Min IRWIN, PhD Vice President, Medical China/Hong Kong, Bayer, China Lily SUN, PhD Senior Medical Director, Pﬁzer Biopharmaceutical Ltd., China Wei YU Associate Medical Director, Medical Affairs, Medical, Pﬁzer Biopharmaceuticals, China

CALL FOR STUDENT POSTERS

For Student Poster Abstract: Now Extended to Sunday, April 15, 2012 The DIA welcomes poster abstract submissions for the Poster Show at the 4th DIA China Annual Meeting. The Student Poster Show is an opportunity to share knowledge, experience, and innovation results with a diverse group of scientiﬁc professionals who are actively involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology products, medical devices, and related healthcare products.

DIA Vision DIA is the global forum for knowledge exchange that fosters innovation to raise the level of health and well being worldwide.

DIA Mission DIA fosters innovation to improve health and well being worldwide by: • Providing invaluable forums to exchange vital information and discuss current issues related to health products, technologies, and services; • Delivering customized learning experiences; • Building, maintaining, and facilitating trusted relationships with and among individuals and organizations that drive and share DIA values and mandates; and • Offering a multidisciplinary neutral environment, respected globally for integrity and relevancy.

GENERAL REQUIREMENTS

Please read the following instructions carefully, incorrect or incomplete abstracts will not be considered. 1. Posters will be presented on May 21-23, 2012. The Theme of the 4th DIA China Annual Meeting is “Collaboration & Innovation in China”. See Part I for Themes that call for Posters. 2. Abstracts must be submitted to [email protected] by April 15, 2012. 3. Posters can be presented in either Chinese or English. 4. The poster title should reflect the abstract content accurately and concisely. 5. All poster presentations must be noncommercial and scientific in nature and may not be used as a marketing opportunity. Any mention of specific products or and/or services must be limited to generic names, with no inclusion of brand names in any area of the poster, including poster titles and/or handouts. Logos and advertising may not appear anywhere on the poster. 6. Posters must be original in research and include appropriate empirical evidence, i.e. research results and conclusion. 7. Preliminary/pilot data is acceptable. 8. DIA grants authors permission to publish abstracts after it appears in the Drug Information Journal (DIJ), provided the publication includes a credit line indicating that your abstract was first published in the DIJ and specifying the volume and issue numbers. 9. It is recommended that authors seek out company/institution approval to provide an electronic copy of poster for the meeting attendee download. 10. Authors will be responsible for organizing all shipping arrangements and paying associated shipping costs for poster materials. DIA will not ship or store any materials. 11. Authors will be responsible for preparing a poster. Poster size is 1.2m (H) × 0.9m (W).

PART I: TARGETED INTEREST AREAS FOR POSTERS The following themes represent the 4th DIA China Annual Meeting. Submitters are encouraged to submit topics related to one of the Themes noted below:

CLINICAL RESEARCH & OPERATIONS

1. Managing Productivity Paradox 5. Signal Detection 2. Remodeling Patient Enrollment Strategies and Execution 6. Pharmacovigilance (PV) in Due Diligence and Licensing Agreement 3. Clinical Site Management System 7. Clinical QA/QC 4. Clinical Site Capability Development

REGULATORY AFFAIRS

1. Medical Devices - Regulatory Requirements and Practices 3. Generics - Regulatory Challenges and Opportunities 2. IP Protection in New Drug Development 4. Experience of CDE Special Review Procedure Formal Consultation

CHEMISTRY, MANUFACTURING & CONTROLS (CMC) 1. Process Analytical Technology (PAT) 4. Packaging Research, Development and Technology 2. Formulation Development for Generic Drugs 5. Technology Transfer 3. Formulation Development for Biological Drugs

VACCINE AND BIOLOGICS

1. MNCs Approach and Opportunities 6. Landscape of CRO and CMO for vaccine and biologics. 2. Vaccine Clinical Trial Planning and Management 7. Biosimiliar and Innovative Vaccine and Biologics Development 3. Regulatory landscape update for vaccine and biologics approval 8. Cell Therapy and Other Innovative Biological Therapeutics 4. Vaccine and Biologics Bioprocess Development for Clinical and 9. China vaccine and biologics market expectation and trend Commercial Production 10. Vaccine and Biologics Technical Approaches to address: Quality, Stability, 5. New GMP implementation and WHO prequaliﬁcation for vaccine and Characterization including but not limited to Aggregation, Impurity, HCP/ biologics production HCDNA, Contamination during Process, Etc. issues.

TRANSLATIONAL MEDICINE

1. Development in Translational Medicine

STATISTICS AND CLINICAL DATA MANAGEMENT (CDM)

1. Regulatory Standards and/or Case Sharing of CDM 4. Proof-of-Concept and Dose Finding Studies 2. Industry and Site Best Practices of Data Management 5. Hot Topics in Quantitative Science 3. Biomarker and Quantitative Translational Science

PART II: REQUIREMENTS FOR STUDENT POSTERS • Eligible individuals must be an undergraduate or graduate student who can document that they are enrolled in a Bachelor’s, Master’s, Pharm.D, MD, Ph.D or equivalent degree-granting or certiﬁcate-granting academic program in an accredited academic institution, whose poster content is consistent with the mission of DIA. • The presented research must have been conducted at an academic institution. • Persons who completed a degree in the 2011 academic year may submit a student poster by providing documentation that they were a student when the research was performed. • A student may submit only one (1) abstract.

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ǖႷሞ౎ሆනമǄࡤሆනǅ ࣷᅱׇ໯˖ ൽၩጀ֩ ฉ࡛ࡔाࣷᅱዐ႐ x සႴൽၩጀ֩Ⴗᇀࡀۨන೺മǄࡤǅᅜກ௬ݛ๕ߢኪ',$ዐࡔ ກ௬ඓණݛ੗๫ྺൽၩׯࠀăڦዐࡔӸࠅ๪$,'ڟڥࡽᆰՊǖ Ӹࠅ๪ժڢٷฉ࡛೶۫՟ॿ x ݐᅙጀ֩ժ޲੼ኁැᇀࡀۨኮනമǄࡤǅൽၩጀ֩',$ዐࡔӸኈدገࣆۉ ๮Ⴤݯට௷Լᇮăأࠅ๪ॽӸ૙ཽ੼๮Ⴤժ੩ ࣷᅱጧკ˖ x ݐᅙጀ֩ժ޲੼ኁැᇈ೺࿄Ӹ૙ൽၩ๮Ⴤॽփᇎཽ੼ă $࠽ׇײᄞ൶۫ෙ࣍ԛୟဪ࠼૛ࡽॅוዐࡔӸࠅ๪ǖԛ৙๨$,' ᆶ࠲๚ᅓăڪዿ໔Ă঍ཚیፗ֫๪ᆰՊǖ x ֖ࣷኁጲႜ޶ሴ৶ +ُཉ੼փ๢ᆩᇀბิጀ֩ኈǖدࣆǖۉ ᆰၒǖIHL[LH#GLDFKLQDRUJGLD#GLDFKLQDRUJ

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```````````````````````````````````````````````````````````````````````````````````````!ጱᆰॲ݀ໃඓණǅۉጱᆰॲǄՂག-ᅜՍཚࡗۉ ఁೌईఁೌްᆇॲڦኈईᆰसԒఁ՗-൩༵ࠃ౞دසࡕ౞ 4th DIA China Annual Meeting - Collaboration & Innovation in China Event I.D. # 12975- May 20-23, 2012 Shanghai, CHINA

TRAVEL AND HOTEL CANCELLATION POLICY*: ON OR BEFORE MAY 10, 2012 Shanghai International Convention Center, China 1. Cancellations must be made in writing and received by May 10, 2727, Riverside Avenue, Pudong New Area, Shanghai, 200120 2012, in order to receive the refund. Tel: +86 21 5037 0000 ext. 6148/6151 Fax: +86 21 5037 0051 2. A cancellation processing fee of RMB 550.00 will be deducted from the refund for each paid registrant. DIA CHINA OFFICE 3. No refund if the written cancellation is not received after May 10, Gateway Plaza, Tower A, Room 1155, 18 XiaGuangLi, North Road, 2012. East Third Ring, Chaoyang District, Beijing, 100027, China 4. Registrant is responsible for own travel, hotel reservation. Tel: +86 10 5923 1222/1288 Fax: +86 10 5923 1180 *This does NOT apply to students E-mail: [email protected]; [email protected]

Online Registration Open, Click Here For More Inforamtion, Please Visit www.diachina.org

REGISTRATION FEES FOR CONFERENCE)Registration fee includes Coffee Breaks, luncheons* INDUSTRY MEMBER NEW MEMBER PACKAGE NON-MEMBER Industry Early-bird* (JAN 19 - APR 30)!! RMB3800 RMB4680 RMB4680 Industry Standard (MAY 01 - MAY 09)!! RMB4300 RMB5180 RMB5180 Industry Onsite (MAY 10 - MAY 23)!! RMB4800 RMB5680 RMB5680 NONPROFIT/ACADEMIA/GOVERNMENT (FULL-TIME) RMB3010 RMB3890 RMB3890 STUDENT (PER DAY) RMB 200 RMB 430 RMB 430 +!It is highly recommended nonmember attendees register the event with New Member Package (Meeting fee + 1 Year Membership Fee) Join DIA now to qualify for the member service and discount! PRE-CONFERENCE WORKSHOPS PAYMENT FULL-DAY WORKSHOPS (MAY 20, 2012) * Payment in other currencies will be subject to the ﬁnancial institution’s exchange rate Ethnicity and Multi-Regional Drug Development RMB2000 Bank Transfer: China and Active Pharmaceutical Ingredients (APIs) - Regu- RMB2000 Payment in the amount of RMB______Meeting I.D. #12975 lations and Inspections Payee: DIA (Beijing) Healthcare Information Consulting Limited Building GCP Quality into e-Clinical Architecture: Concepts RMB2000 and Practices of Computer Validation Bank Name: Bank of China, Beijing Chaoyang Sub-branch Banking Dept. First in Human (FIH) RMB2000 Bank Account: 333757195112 Drug Risk Assessment and Management at US FDA - A Case RMB2000 SWIFT Code: BKCH CN BJ 110 Study of Drug That Was Marketed, Withdrawn and Then Re- Bank Address: 1st Floor, Tower A, Gateway, No.18 Xiaguangli, North introduced in US Market Road, East Third Ring, Chaoyang District, Beijing, 100027, P.R.China HALF-DAY WORKSHOPS (MAY 20, 2012) CREDIT CARD PAYMENTS BY: Ethical Medical Writing Practices - Every Document, Every RMB1300 Cardholder Name ______Time, Every Country! (morning) Career Development in Today’s Competitive Market (afternoon) RMB1300 Card Issue Bank______Exp. Date (mm/yyyy)______Card #______Security Code______CHINESE OFFICIAL INVOICE (FA PIAO) Visa Master Card Signature______If you need a Chinese official invoice, Please complete following below GROUP DISCOUNT: Group registration attendees will obtain corre- Name/Company on Fapiao ______sponding complimentary registration(s) (excluding pre-conference workshops). Group registration does NOT apply to students and the regis- Amount Charged RMB ______trants from government, academia, nonproﬁt organizations. To apply for Group Discount, please contact DIA China office: +86 10 5923 1222 Item Meeting Fee Training Fee * Click Here to Downlaod Group Registration Form!

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