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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.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; ... Pharmaceutical legislation: medicinal ...
The 9th World Conference on Clinical Pharmacology and Therapeutics in Québec City, Canada was the last IUPHAR meeting to present clinical pharmacology separately. The World Congress of Basic and Clinical Pharmacology in Copenhagen , Denmark on July 17–23, 2010 [ 19 ] was the first integrated meeting.
The International Pharmaceutical Students' Federation (IPSF) is a non-governmental, non-political and non-religious organisation that represents pharmaceutical students, pharmacy students and recent graduates from all over the world. It was founded in 1949 and it is the oldest faculty-based student organisation.
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [ 1 ] [ 2 ] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [ 3 ] and Switzerland.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) [2] is a trade association that represents internationally over 90 pharmaceutical companies and associations around the world. IFPMA is based in Geneva and is in official relations with the United Nations [3] where it contributes industry expertise to global ...