<p> International Conference organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe E</p><p>R CERTIFICATION PROCEDURE U</p><p>D 1992 - 2012: 20 Years of Experience</p><p>E 22-23 March 2012 C</p><p>O Duration: 1.5 days, Location: Palm Beach Hotel, Larnaca, Cyprus R</p><p> s Working language: English P u</p><p> r *** p N</p><p> y PROGRAMME O C I</p><p>, Thursday, 22 March 2012 T a c A a</p><p>C 8:00-9:00 Registration n I r F a I</p><p>L 9:00-9:10 Opening remarks</p><p>T , l Dr Susanne Keitel, Director of the European Directorate for the Quality of R e t</p><p>E Medicines & HealthCare (EDQM), Council of Europe o C H</p><p>Welcome Address h E Mr George Antoniou, Ministry of Health, Pharmaceutical Services, Republic of c H a Cyprus e T</p><p>B</p><p>N m</p><p> l PLENARY SESSION O</p><p> a Moderator: Dr Mike Morris, Chair of the Certification Steering Committee P E</p><p>: C</p><p> n 9:10-9:25 The Evolution of the European Pharmacopoeia and its impact on the N o i</p><p>E Certification procedure t R</p><p> a Dr Marianne Ek, Chair of the European Pharmacopoeia Commission E c F o 9:25-9:45 New developments in Certification and place of the procedure within the L N European regulatory framework – O</p><p>C Dr Jean-Louis Robert, Chair of the Joint CHMP/CVMP Quality Working Party </p><p>2</p><p>L and Former Chair of the Certification Steering Committee 1 A 0 N</p><p>2 9:45-10:15 ‘Remember the Pioneers’ </p><p>O Why did we invent the Certification Procedure? - Could not live without it! I H</p><p>T Prof. Per Helboe, First Chair of the Technical Advisory Board (TAB) for the C</p><p>A Certification Procedure R N Where do we stand after 20 years of running the certification procedure? A A R review E M</p><p>T Dr Wilhelm Schlumbohm, Assessor for the Certification Procedure and Former 3 N</p><p>I Member of the TAB, BVL, Germany 2</p><p>- :</p><p>E 2 10:15-10:45 Coffee break 2 M</p><p>M 10:45-11:05 Use of CEPs outside Europe: Health Canada’s experience</p><p>A Dr Amirthini Rajkumar, Health Canada</p><p>R</p><p>G 11:05-11:25 Use of CEPs outside Europe: Therapeutic Goods Administration’s experience O Dr Michael Pass, Therapeutic Goods Administration, Australia R P 11:25-11:45 Inspections of API manufacturers: What is new? What are the new challenges to face? Opportunities of international collaboration Mr Olivier Gross, Scientific Administrator, EMA</p><p>11:45-12:05 Inspections of API manufacturers: Experience of the EDQM E R U D E C O R s P u</p><p> r p N y O C I</p><p>, T a c A a C n I r F a I L</p><p>T , l R e t E o C H</p><p> h E c H a e T</p><p>B</p><p>N m l O</p><p> a P E</p><p>: C n N o i E t R a E c F o N L</p><p>O –</p><p>C</p><p>2 L 1 A 0 N 2</p><p>O I H T C A R N A R E M</p><p>T 3 N I 2</p><p>- :</p><p>E 2 2 M</p><p>M</p><p>A</p><p>R</p><p>G</p><p>O</p><p>R</p><p>P</p><p>Dr Thomas Hecker, Inspector, EDQM, Council of Europe</p><p>E 12:05-12:35 Discussion R 12:35 -14:00 Lunch break U D</p><p>E WORKSHOP SESSIONS C There will be three parallel workshops (1st Session: 14:00-15:30 and 2nd Session: 16:00-17:30) O</p><p>R You are required to choose two workshops you wish to participate in when registering. s P u</p><p> r p N y</p><p>O Time Workshop 1 Workshop 2 Workshop 3 C I</p><p>, T</p><p> a The EDQM inspection c A</p><p> a programme and C</p><p> n st Process description I</p><p> r 1 Session international Quality of antibiotics and F a and definition of I</p><p>L 14:00-15:30 collaboration in the fermentation products</p><p>T , starting materials l area of inspections of R e t</p><p>E API manufacturers o C H</p><p> h 15:30-16:00 Coffee Break E c H a</p><p> e The EDQM inspection T</p><p>B nd programme and N 2 Session Process description m</p><p> l international Quality of antibiotics and O</p><p> a 16:00-17:30 and definition of collaboration in the fermentation products P E</p><p>(Repeated) starting materials :</p><p>C area of inspections of n</p><p>N API manufacturers o i E t R a</p><p>E . WORKSHOP 1: Process description and definition of starting materials c F o Moderator: Dr Andrew McMath, Scientific Administrator, EDQM, Council of Europe L N</p><p> o National assessor taking part in Certification – O</p><p>Dr Cornelia Nopitsch Mai, Federal Ministry of Health, Germany C</p><p>2 Industry representative</p><p>L o 1 A</p><p>0 Mrs Hilde Vanneste, Cefic/APIC N 2 o National Inspector </p><p>O I</p><p>H Mr Lionel Viornery, Afssaps, France T C A</p><p>R .WORKSHOP 2: The EDQM inspection programme and international collaboration in N A</p><p>R the area of inspections of API manufacturers E M Moderator: Dr Thomas Hecker, Inspector, EDQM, Council of Europe</p><p>T</p><p>3 o U.S. Food and Drug Administration - FDA N I 2 Dr Janice Soreth, Deputy Director, FDA Europe Office, Liaison to EMA - :</p><p>E 2 o Therapeutic Goods Administration – TGA – Australian Inspectorate 2 M Mr Bill Turner, Office Head of the Office of Manufacturing Quality</p><p>M o European Medicines Agency - EMA A Mr Olivier Gross, Scientific Administrator R</p><p>G</p><p>O . WORKSHOP 3: Quality of antibiotics and fermentation products</p><p>R Moderator: Mrs Hélène Bruguera, Head of the Certification of Substances Division, EDQM, P Council of Europe o Quality of fermentation products Prof. Jos Hoogmartens, Chair of the EDQM Group of Experts on Antibiotics o New EU Guideline on antibiotics Dr Tone Agasoster, Norwegian Medicines Agency E R U D E C O R s P u</p><p> r p N y O C I</p><p>, T a c A a C n I r F a I L</p><p>T , l R e t E o C H</p><p> h E c H a e T</p><p>B</p><p>N m l O</p><p> a P E</p><p>: C n N o i E t R a E c F o N L</p><p>O –</p><p>C</p><p>2 L 1 A 0 N 2</p><p>O I H T C A R N A R E M</p><p>T 3 N I 2</p><p>- :</p><p>E 2 2 M</p><p>M</p><p>A</p><p>R</p><p>G</p><p>O</p><p>R</p><p>P</p><p> o European Pharmacopoeia (Ph. Eur.) monographs for fermentation products Dr Jan W. H. Smeets, Expert of the EDQM Group of Experts on Antibiotics Friday, 23 March 2012 E</p><p>R PLENARY SESSION</p><p>U Moderator: Dr Susanne Keitel, Director, EDQM, Council of Europe D E</p><p>9:00-10:00C 9:00-10:00 Feedback from the Workshops</p><p>O Dr Mike Morris, Chair of the Certification Steering Committee R s P u</p><p> r 10:00-11:50 The Interests, Use and Limits of Certificates: Viewpoints from the p N</p><p> y industry and regulatory authorities O C I</p><p>, T a Industry Associations c A a</p><p>C 10:00-10:10 European Federation of the Pharmaceutical Industries and Associations (EFPIA) n I r , Vice President Global Quality Strategy & International </p><p>F Dr Georges France a I L</p><p>Affiliate Quality & Compliance (Novartis, Switzerland) T , l R e 10:10-10:20 European Generic Medicines Association (EGA) t E</p><p> o Dr Elli Souli, Regulatory Affairs Supervisor (Medochemie Ltd, Cyprus) C H</p><p>10:20-10:30 Association of the European Self-Medication Industry (AESGP) – Views of the h E</p><p> c self-care Sector H a</p><p> e Dr Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager T</p><p>B</p><p>(AESGP) N m</p><p> l 10:30-10:40 European Chemical Industry Council (Cefic) / Active Pharmaceutical Ingredients O</p><p> a Committee (APIC) P E</p><p>:</p><p>C Mrs Hilde Vanneste, Associate Director Global CMC Regulatory Affairs (Janssen n</p><p>N Pharmaceutica NV, Belgium) o i E</p><p> t 10:40-10:50 China Chamber of Commerce for Import & Export of Medicines & Health R a Products (CCCMHPIE) E c F</p><p> o Dr Ming Xu, Vice President (CCCMHPIE) L N</p><p>– O</p><p>10:50-11:20 Coffee break C</p><p>2 L 1 11:20-11:40 Regulatory authorities from Europe A 0 N</p><p>2 Mr Malcolm Dash, MHRA, United Kingdom</p><p>O I H</p><p>T 11:40-12:15 Discussion C A R N 12:15-12:45 The benefits and cross-functional links between the Certification procedure, A R the European Pharmacopoeia, the EMA and National Authorities E M</p><p>T Dr Jean-Louis Robert, Chair of the Joint CHMP/CVMP Quality Working Party 3 N</p><p>I and Former Chair of the Certification Steering Committee 2</p><p>- :</p><p>E 2</p><p>2 12:50 Close of meeting M M 13:00 Lunch A</p><p>R</p><p>G For further information, please contact the EDQM Public Relations Division & Documentation: O Mrs F. Baumgarthen, Tel.: +33 (0)3 88 41 28 24 *, Fax: +33 (0)3 88 41 27 71 *, R E-mail: [email protected] P Postal address: EDQM, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France</p><p>* Leave out 0 if calling from outside France</p>