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Minutes of the CHMP Meeting 14-17 September 2020
13 January 2021 EMA/CHMP/625456/2020 Corr.1 Human Medicines Division Committee for medicinal products for human use (CHMP) Minutes for the meeting on 14-17 September 2020 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes Disclaimers Some of the information contained in these minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, these minutes are a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). 1 Addition of the list of participants Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020. -
Connections Between Sámi and Basque Peoples
Connections between Sámi and Basque Peoples Kent Randell 2012 Siidastallan Outside of Minneapolis, Minneapolis Kent Randell (c) 2012 --- 2012 Siidastallan, Linwood Township, Minnesota Kent Randell (c) 2012 --- 2012 Siidastallan, Linwood Township, Minnesota “D----- it Jim, I’m a librarian and an armchair anthropologist??” Kent Randell (c) 2012 --- 2012 Siidastallan, Linwood Township, Minnesota Connections between Sámi and Basque Peoples Hard evidence: - mtDNA - Uniqueness of language Other things may be surprising…. or not. It is fun to imagine other connections, understanding it is not scientific Kent Randell (c) 2012 --- 2012 Siidastallan, Linwood Township, Minnesota Documentary: Suddenly Sámi by Norway’s Ellen-Astri Lundby She receives her mtDNA test, and express surprise when her results state that she is connected to Spain. This also surprised me, and spurned my interest….. Then I ended up living in Boise, Idaho, the city with the largest concentration of Basque outside of Basque Country Kent Randell (c) 2012 --- 2012 Siidastallan, Linwood Township, Minnesota What is mtDNA genealogy? The DNA of the Mitochondria in your cells. Cell energy, cell growth, cell signaling, etc. mtDNA – At Conception • The Egg cell Mitochondria’s DNA remains the same after conception. • Male does not contribute to the mtDNA • Therefore Mitochondrial mtDNA is the same as one’s mother. Kent Randell (c) 2012 --- 2012 Siidastallan, Linwood Township, Minnesota Kent Randell (c) 2012 --- 2012 Siidastallan, Linwood Township, Minnesota Kent Randell (c) 2012 --- 2012 Siidastallan, Linwood Township, Minnesota Four generation mtDNA line Sisters – Mother – Maternal Grandmother – Great-grandmother Jennie Mary Karjalainen b. Kent21 Randell March (c) 2012 1886, --- 2012 Siidastallan,parents from Kuusamo, Finland Linwood Township, Minnesota Isaac Abramson and Jennie Karjalainen wedding picture Isaac is from Northern Norway, Kvaen father and Saami mother from Haetta Kent Randell (c) 2012 --- 2012 Siidastallan, village. -
UAX #44: Unicode Character Database File:///D:/Uniweb-L2/Incoming/08249-Tr44-3D1.Html
UAX #44: Unicode Character Database file:///D:/Uniweb-L2/Incoming/08249-tr44-3d1.html Technical Reports L2/08-249 Working Draft for Proposed Update Unicode Standard Annex #44 UNICODE CHARACTER DATABASE Version Unicode 5.2 draft 1 Authors Mark Davis ([email protected]) and Ken Whistler ([email protected]) Date 2008-7-03 This Version http://www.unicode.org/reports/tr44/tr44-3.html Previous http://www.unicode.org/reports/tr44/tr44-2.html Version Latest Version http://www.unicode.org/reports/tr44/ Revision 3 Summary This annex consolidates information documenting the Unicode Character Database. Status This is a draft document which may be updated, replaced, or superseded by other documents at any time. Publication does not imply endorsement by the Unicode Consortium. This is not a stable document; it is inappropriate to cite this document as other than a work in progress. A Unicode Standard Annex (UAX) forms an integral part of the Unicode Standard, but is published online as a separate document. The Unicode Standard may require conformance to normative content in a Unicode Standard Annex, if so specified in the Conformance chapter of that version of the Unicode Standard. The version number of a UAX document corresponds to the version of the Unicode Standard of which it forms a part. Please submit corrigenda and other comments with the online reporting form [Feedback]. Related information that is useful in understanding this annex is found in Unicode Standard Annex #41, “Common References for Unicode Standard Annexes.” For the latest version of the Unicode Standard, see [Unicode]. For a list of current Unicode Technical Reports, see [Reports]. -
Independent-Living-Mini-Catalogue
Alternative Thinking INDEPENDENT LIVING DAILY LIVING AIDS MAGNIFIERS ALERT SYSTEMS ASSISTIVE DEVICES Page 24 Page 29 Page 4 Page 16 ...AND MUCH MORE AUDITORY AND HEARING IMPAIRMENT BLIND & VISUALLY IMPAIRED Tel: +27 (0) 86 111 3973 Email: [email protected] Web: www.editmicro.co.za DOCUMENT CAMERAS Solo 8 Ultra Ultra Plus 8 10 Solo 8 Plus Features Ultra 8 Features Ultra 10 Features The HoverCam Solo 8 is a new, The HoverCam Ultra 8 is the the first The HoverCam Ultra 10 takes the state-of-the-art document camera document camera with HDMI, VGA document camera experience to that will revolutionize learning in & SuperSpeed USB 3.0 outputs and a whole new level with a 7.1” HD your classroom. Record videos or includes an LCD monitor for preview MultiTouch screen. Pinch to Zoom, capture images straight to your and touchscreen control. Record Annotate, and Cast 4K video to any PC or Mac with the world’s first videos or capture images straight display. SuperSpeed USB3.0 Document to your PC or Mac with the world’s Camera. Use the HoverCam Solo first SuperSpeed USB3.0 Document Download your favorite apps and 8 to bring your classroom into the Camera. experience Augmented Reality and digital age! The HoverCam Solo Optical Character Recognition right 8 does everything except travel Specifications from the device. through time. • 8 megapixel camera Specifications • 60FPS FullMotion HD Specifications • HDMI VGA • Battery Powered • 8 megapixel camera • USB 3.0 SuperSpeed • 3 Wireless Casting Modes • 3x magnification with 8 million • 12x Optical Zoom Equivalent • 16 MP Camer Sensor uncompressed pixels • LCD Control Panel • 4K @ 30FPS Lesson Recording • 10x magnification mechanically • 4x ASR Zoom, 8x Interpolated • WiFi and Bluetooth Connectivity • 8x magnification digitally with Digital Zoom, 10x Mechanical • Powerful Android Operating System interpolation Zoom. -
IADD BANA Braille Standards
Let Your Fingers Do The Talking: Braille on Folding Cartons in cooperation with February 2012 (Revision 1) 1 Preface 4 History of braille in folding carton production and references 2 Traditional Braille Cell and Braille Characters 5 Letters, punctuation marks, numbers, special characters 3 Standardization 7 Dot matrix, dot diameters, dot spacing, character and line spacing, embossing height, positioning the braille message 4 Technical Requirements 8 Functional and optical characteristics, material selection 5 Fabrication 9 Braille embossing, positioning of braille, amount of text 6 Prepress and Quality Assurance 12 Artwork files and print approvals, quality assurance 7 Conclusion 14 3 1 Preface In 1825, Frenchman Louis Braille (1809-1852) invented a reading system for the blind through which the alphabet, numbers and punctuation marks were represented in a tangible form via a series of raised dots. The braille system established itself internationally and is now in use in all languages. While A to Z is standardized, there are, of course, special characters which are unique to local languages. The requirement for braille on pharmaceutical packaging stems from the European Directive 2004/27/EC – amending Directive 2001/83/EC (community code to medicinal products for human use). This Directive includes changes to the label and package leaflet requirements for pharmaceuticals (which will not be discussed in this booklet). It requires pharmaceutical cartons to show the name of the medicinal products and, if need be, the strength in braille format. The influence of the European Directive is having an increasing impact on Canada, USA and other countries worldwide through the pharmaceutical packaging companies that produce for or market at an international level. -
American Esperanto Magazine
AMERIKA ESPERANTISTO AMERICAN ESPE RANTO MAGAZINE Esperanto & Travel Council of Europe Don Giovanni kal Mi MAR-A PR 1956 AMERICAN ESPERANTO MAGAZINE (Amerika Esperanfisto) Official bimonthly publication of the ESPER-1NTO ASSOCIATION OF NORTh AMERICA, Inc. 114 West 16 St., New York u.N. Y. FIJITORIAL STAFF Ldztor C Alan Connor. Cu -Lditors; Dr. \‘illiam Solzbacher, Doris. I’. Connor, Myron R. Mychajliw. SUSTAINING BOARD OF EANA Dr. Luella K. Beecher, Dr. F. W. Breth, Allen L. Brown, A.M.Brya, John Burt, Carl W. Childress, C. C Cummingsmith, S. M. ,Preston Davis, Jr. Dr. LeeMin Han, Allan Hutcheon, Horace C. Jenkins, Dr,Francis A. Ku- beck, Katherine Muttart, Merrill E. Muttart, Bertha F. Mullin, Paul E.Nace, George Hirsch, Bertha F. Sloan, Harold S Sloan. Dr. W. Solzbacher, Mazah E. Schulz, Virgil Whanger. CONTENTS — ENIIAV() Esperanto — Language of World Travel ....... ... 35 Esperanto and the Council of Europe ........ 38 ..... Esperanto in Action Around the World - . 41 Esperanto in the Schools 44 . 46 Even the Blind Can See the Merit of Esperanto . J. Henry Kruse,Jr. Editorial in “Life” and Facts of Life Doris T. Connor 47 Rezolucio Kontraü Misuzo de la UFA Statuto - . ,...- . G. Alan Connor 48 Nia Konkurso pri Varbado de Novaj Membroj . 49 “La Infanoj de Ia Mondo” — Japana Eldona Entrepreno. 50 .... .... Perrine .. ...... George H. Don Giovanni kaj Mi . 51 La Ilustrita Vortaro de Easperanto . Donald R. Broadribb 55 . i Esperanta Kroniko 58 Niaj Pioniroj . 60 Komentoj pri I.V,E....... .,. ,......., . Francisco Azorzn 61 Deziras Korespondi ......... .... .... ...,...... 62 Bildo sur kovrilo: Asfodeloj inter Betuloj —Signo de Printempo Subscrirtions in the United States and Canada: 53.00 per year. -
New York Statewide Data Warehouse Guidelines for Extracts for Use In
New York State Student Information Repository System (SIRS) Manual Reporting Data for the 2015–16 School Year October 16, 2015 Version 11.5 The University of the State of New York THE STATE EDUCATION DEPARTMENT Information and Reporting Services Albany, New York 12234 Student Information Repository System Manual Version 11.5 Revision History Version Date Revisions Changes from 2014–15 to 2015–16 are highlighted in yellow. Changes since last version highlighted in blue. Initial Release. New eScholar template – Staff Attendance. CONTACT and STUDENT CONTACT FACTS fields for local use only. See templates at http://www.p12.nysed.gov/irs/vendors/2015- 16/techInfo.html. New Assessment Measure Standard, Career Path, Course, Staff Attendance, Tenure Area, and CIP Codes. New Reason for Ending Program Service code for students with disabilities: 672 – Received CDOS at End of School Year. Reason for Beginning Enrollment Code 5544 guidance revised. Reason for Ending Enrollment Codes 085 and 629 clarified and 816 modified. 11.0 October 1, 2015 Score ranges for Common Core Regents added in Standard Achieved Code section. NYSITELL has five performance levels and new standard achieved codes. Transgender student reporting guidance added. FRPL guidance revised. GED now referred to as High School Equivalency (HSE) diploma, language revised, but codes descriptions that contain “GED” have not changed. Limited English Proficient (LEP) students now referred to as English Language Learners (ELL), but code descriptions that contain “Limited English Proficient” or “LEP” have not changed. 11.1 October 8, 2015 Preschool/PreK/UPK guidance updated. 11.2 October 9, 2015 Tenure Are Code SMS added. -
MOHAMMED SAMI FADALI Resume
MOHAMMED SAMI FADALI CURRICULUM VITAE PRESENT POSITION: Professor and Chair Department of Electrical & Biomedical Engineering College of Engineering University of Nevada Reno, NV 89557-0153 PRINCIPAL PAST POSITION: Assistant Professor, King Abdul Aziz University, Jeddah, 1981-83. PLACE AND DATE OF BIRTH: Cairo, Egypt, May 22, 1952. NATIONALITY: U.S. LANGUAGES: English, Arabic, Spanish, French. PERMANENT ADDRESS: 3959 Regal Dr., Reno, NV 89503 Work Phone: (775)784-6951 Home Phone: (775)747-4832 MARITAL STATUS: Married RESEARCH INTERESTS: Intelligent control, fuzzy logic, fault detection, control of renewable energy systems, structural control, random signals, mathematical modeling of biological systems, engineering education. EDUCATION: DEGREE DEPARTMENT UNIVERSITY YEAR B.S. Electrical Engineering Cairo Univ., Cairo, Egypt. 1974 M.S. Control Systems Center UMIST, Manchester, England 1977 Ph.D. Electrical Engineering Univ. of Wyoming, Laramie, Wy, USA 1980 POSITIONS HELD: University of Nevada-Reno, Professor 1995-Present, Associate Professor 1989 to 1995, Assistant Professor, 1985-89, tenured 1991 Duties include teaching, funded research, graduate and undergraduate advising, Assessment Coordinator. Chairman Department Curriculum Committee, Past: Graduate Student MOHAMMED SAMI FADALI PAGE 2 Coordinator and Chair of Graduate Admission Committee 1989-98, Member Univeristy Conflict of Interest Committee, Past Chair College Personnel Committee. Colorado State University, Post Doctoral Fellow, 1984-1985 Investigated problems in robotics, satellite maneuvering,biochemical process control and physiological system identification. King Abdul Aziz University, Jeddah, Assistant Professor, 1981-1983. Duties included teaching, undergraduate advising and research. Participated in starting a new bioengineering program. University of Wyoming, Teaching Assistant, 1979-80. Taught several introductory electrical engineering labs. Cairo Research Center, Engineer, 1975. Participated in research on computer control of electrical machines. -
The Braille Font
This is le brailletex incl boxdeftex introtex listingtex tablestex and exampletex ai The Br E font LL The Braille six dots typ esetting characters for blind p ersons c comp osed by Udo Heyl Germany in January Error Reports in case of UNCHANGED versions to Udo Heyl Stregdaer Allee Eisenach Federal Republic of Germany or DANTE Deutschsprachige Anwendervereinigung T X eV Postfach E Heidelb erg Federal Republic of Germany email dantedantede Intro duction Reference The software is founded on World Brail le Usage by Sir Clutha Mackenzie New Zealand Revised Edition Published by the United Nations Educational Scientic and Cultural Organization Place de Fontenoy Paris FRANCE and the National Library Service for the Blind and Physically Handicapp ed Library of Congress Washington DC USA ai What is Br E LL It is a fontwhich can b e read with the sense of touch and written via Braille slate or a mechanical Braille writer by blinds and extremly eyesight disabled The rst blind fontanight writing co de was an eight dot system invented by Charles Barbier for the Frencharmy The blind Louis Braille created a six dot system This system is used in the whole world nowadays In the Braille alphab et every character consists of parts of the six dots basic form with tworows of three dots Numb er and combination of the dots are dierent for the several characters and stops numbers have the same comp osition as characters a j Braille is read from left to right with the tips of the forengers The left forenger lightens to nd out the next line -
On the Status of the Icelandic Language and Icelandic Sign Language
No. 61/2011 7 June 2011 Act on the status of the Icelandic language and Icelandic sign language. THE EXECUTANTS OF THE POWERS OF THE PRESIDENT OF ICELAND under Article 8 of the Constitution, the Prime Minister, the Speaker of the Althingi and the President of the Supreme Court, make known: the Althingi has passed this Act, and we confirm it by our signatures: Article 1 National language – official language. Icelandic is the national language of the Icelandic people and the official language in Iceland. Article 2 The Icelandic language. The national language is the common language of the people of Iceland. The government authorities shall ensure that it is possible to use it in all areas of the life of the nation. Everyone who is resident in Iceland shall have the opportunity of using Icelandic for general participation in the life of the Icelandic nation as provided for in further detail in separate legislation. Article 3 Icelandic sign language. Icelandic sign language is the first language of those who have to rely on it for expression and communication, and of their children. The government authorities shall nurture and support it. All those who need to use sign language shall have the opportunity to learn and use Icelandic sign language as soon as their language acquisition process begins, or from the time when deafness, hearing impairment or deaf-blindness is diagnosed. Their immediate family members shall have the same right. Article 4 Icelandic Braille. Icelandic Braille is the first written language of those who have to rely on it for expression and communication. -
National Museums in Sápmi Arne Bugge Amundsen
Building National Museums in Europe 1750-2010. Conference proceedings from EuNaMus, European National Museums: Identity Politics, the Uses of the Past and the European Citizen, Bologna 28-30 April 2011. Peter Aronsson & Gabriella Elgenius (eds) EuNaMus Report No 1. Published by Linköping University Electronic Press: http://www.ep.liu.se/ecp_home/index.en.aspx?issue=064 © The Author. National Museums in Sápmi Arne Bugge Amundsen Summary A case of high complexity, when discussed in a national museum perspective, is Sápmi, the accepted name of the multi-state area of the ’Sámi nation’ of Northern Europe. In the Sápmi case, museum history should be told in a retrospective manner. It is quite a recent phenomenon that the Sámi population in Norway, Sweden, Finland and Russia – after centuries of political suppression and decades of systematic assimilation strategies from the governments – is regarded as a nation and with Sápmi – the transnational area where the Sámi population has its traditional centre – as its geographical location. In this case, ‘the nation’ is conceived as a cultural and social entity with strong political ambitions both within and across established national borders in the region. Hence, there are no old national museums and no politically acknowledged Sámi state but explicit ideas on ‘national identity’. On the one hand, the Sámi population and the Sámi culture to a certain extent were included in the national narratives of Norway, Sweden and Finland in the nineteenth century, then mostly as an exotic element of the nation and exemplifying ‘primitive cultures’ of the north. On the other hand, the Sámi nation is a cultural construction of recent origin, albeit with some political institutions within and across established states. -
Alphabets: a Miscellany of Letters Free
FREE ALPHABETS: A MISCELLANY OF LETTERS PDF David Sacks | 240 pages | 09 Nov 2010 | Black Dog Publishing London UK | 9781907317095 | English | London, United Kingdom Alphabets: A Miscellany of Letters by David Sacks, Hardcover | Barnes & Noble® But a new book by David Sacks offers much more depth than the designerly eye candy the genre lends itself to. Alphabets: A Miscellany of Letters is an ambitious exploration of the pervasiveness of letters in everyday life, tracing our visual vocabulary to its roots in Egyptian hieroglyphs, Kanji characters and other ancient alphabets with rich illustrations, beautiful graphic design and typography, found objects, graffiti and more. Sacks explores the persona of each of the 26 letters of the alphabet, treating it as a separate symbol with its own design history Alphabets: A Miscellany of Letters cultural legacy. And Alphabets: A Miscellany of Letters a special tickle of our appetite for creative derivatives of the London Tube mapthis gem:. From Braille to the Morse code to Muji alphabet ice cube moulds, Alphabets covers an astounding range of linguistic symbolism, giving the nostalgically familiar alphabet book of our childhoods an adult upgrade with remarkable design sophistication and aesthetic sensibility. Images courtesy of The Guardian. Brain Pickings participates in the Amazon Services Alphabets: A Miscellany of Letters Associates Program, an affiliate advertising program designed to provide a means for sites to earn commissions by linking to Amazon. In more human terms, this means that whenever you buy a book on Amazon from a link on here, I receive a small percentage of its price. Privacy policy. Share Article Tweet.