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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
The European Medical Association (EMA) was established by doctors from the 12 member states in 1990 in Belgium, [1] EMA is the main association representing Medical Doctors in Europe, supporting the European Commission - Lifelong Learning Programme (LLP).
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Ms Cooke joined EMA on 1 July 2002 where she worked first as Head of Inspections and then as Head of International Affairs. [4] From 2021 she was appointed as Head of Regulation of Medicines and other Health Technologies with the World Health Organization (WHO).
In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs). These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of ...
Joseph J. Fins, M.D., D. Hum. Litt., M.A.C.P., F.R.C.P. (born 1959) is an American physician and medical ethicist.He is chief of the Division of Medical Ethics at New York Presbyterian Hospital and Weill Cornell Medical College, where he serves as The E. William Davis Jr., M.D. Professor of Medical Ethics, and Professor of Medicine, Professor of Public Health, and Professor of Medicine in ...
Joseph L. Price (Joe Price) is an American professor. Since 1982, Price has been a Religious Professor at Whittier College , a secular liberal arts college in Whittier, California . [ 1 ] [ 2 ] [ 3 ] His teaching of sports and religion has brought media attention and he has been featured as a guest speaker on NPR , appeared in a segment on the ...