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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.
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 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.
Training programs were designed with an aim to providing members with up-to-date skills and resources needed in pharmaceutical market research. [9] Both online and face-to-face training are offered, covering topics including data privacy, regulatory compliance, and ethics.
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.
52 weeks of pre-registration training and; pass a registration examination. This gave them the right to use the post-nominal letters MRPharmS (Member of the Royal Pharmaceutical Society) and to practise as pharmacist in Great Britain. Fellowships (FRPharmS) were also awarded for pharmacists with long standing and outstanding commitment to the ...
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In 2012, at the margins of the 65th World Health Assembly conference in May the Minister of Health of Brazil proposed an agenda to create a new coalition of Heads of Agency "to address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner."