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Regulatory Update.
- Source :
- GMP Review; Jul2016, Vol. 15 Issue 2, p12-18, 7p
- Publication Year :
- 2016
-
Abstract
- The article offers information on developments in the regulations of the pharmaceutical industry. Topics discussed include the European Medicines Agency starting to review the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation, the EU Good Manufactuing Practices needed for sterilisation processes of primary packaging and introduction and implementation of safety features on packaging.
Details
- Language :
- English
- ISSN :
- 14764547
- Volume :
- 15
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- GMP Review
- Publication Type :
- Periodical
- Accession number :
- 118429736