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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]).
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).
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).
James Jude Orbinski is a Canadian physician, humanitarian activist, author, and scholar in global health. [1] Dr. Orbinski began his role as principal of Massey College at the University of Toronto in the 2024-2025 academic year, where he is also Full Professor in the Department of Family and Community Medicine in the Temerty Faculty of Medicine, and is cross-appointed to the Munk School of ...
James Homer Wright (April 8, 1869 – January 3, 1928) was an early and influential American pathologist, who was chief of pathology at Massachusetts General Hospital from 1896 to 1926. Wright was born in Pittsburgh, Pennsylvania .
James Edward Bowman was born on February 5, 1923, in Washington, D.C., the eldest of five children [7] of Dorothy Bowman (née Peterson), a homemaker, and James Edward Bowman Sr., a dentist. [8] His parents were African-American. [9] He attended Dunbar High School before earning his undergraduate and medical degrees from Howard University in ...