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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 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]).
Emer Cooke is an Irish pharmacist and Executive Director of the European Medicines Agency (EMA) since November 2020. [1] She is also the chairperson at the International Coalition of Medicines Regulatory Authorities (ICMRA).
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 A. Schwarcz CM (born 1947) is an author and a sessional instructor at McGill University. He is the director of McGill's Office for Science and Society . Early life
Joseph E. Bavaria, M.D., FACS, FRCS (Edin) ad hom, (born 1957) is an American cardiothoracic surgeon [6] a professor of surgery at the University of Pennsylvania and Director of its Thoracic Aortic Surgery Program.
Joseph Francis Shea (September 5, 1925 – February 14, 1999) was an American aerospace engineer and NASA manager. Born in the New York City borough of the Bronx , he was educated at the University of Michigan , receiving a Ph.D. in Engineering Mechanics in 1955.