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Volume 7 - Guidelines. Volume 8 - Maximum residue limits. Concerning Medicinal Products for Human and Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous: Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] 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 ...
The Medical School Admission Requirements Guide (MSAR) is a suite of guides produced by the Association of American Medical Colleges (AAMC), [1] which helps inform prospective medical students about medical school, the application process, and the undergraduate preparation. The MSAR staff works in collaboration with the admissions offices at ...
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]).
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The Association of American Medical Colleges (AAMC) is a 501(c)(3) nonprofit organization based in Washington, D.C. that was established in 1876. It represents medical schools, teaching hospitals, and academic and scientific societies, while providing services to its member institutions that include data from medical, education, and health studies, as well as consulting.
In the UK, the UCAT was one of two main admissions tests used for medical, dental and other health-related courses, the other being the BioMedical Admissions Test (BMAT). Following the BMAT's cancellation from 2024 onwards, all ex-BMAT universities have moved to using the UCAT for their undergraduate medical courses, including Oxford and Cambridge.