SIGNAL DETECTION IN VETERINARY PHARMACOVIGLIANCE - THE EUROPEAN APPROACH
37 / 27
Authors
-
C. Colmar
Pharmacovigilance Expert (DVM)ANMV (French Agency for Veterinary Medicinal Products, Fougères, France)
Abstract
Nil
Downloads
References
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
ICH Harmonised Tripartite Guideline E2C (R2): Periodic
Benefit-Risk Evaluation Report (PBRER). 17, 2012.
Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/ EC on the community code relating to medicinal products for human use. Official Journal of the European Union. http://ec.europa.eu/health/files/ eudralex/vol-1/dir_ 2010_84/ dir_2010_84_ 15, 2010
Pharmacovigilance Legislation: The Impact of what is happening in Europe, Miranda Z. Dolle, Therapeutic Innovation& Regulatory Science 00(0) 1-10
N.WOOD WARD, Veterinary pharmacovigilance. Part 1. The legal basis in the European Union, K. Journal of Veterinary Pharmacology and Therapeutics, Volume 28, Issue 2, pages 131–147, April 2005.
Downloads
Submitted
Published
Issue
Section
License
All the copy right belongs to the sponsoring Organization, Tamil Nadu Veterinary and Animal Sciences University, Chennai - 51.
How to Cite
