Guideline on good pharmacovigilance practices ( GVP ) Module
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Draft agreed by ERMS FG 20 July 2012 Draft adopted by Executive Director 25 July 2012 Start of public consultation 26 July 2012 End of consultation (deadline for comments) 21 September 2012 Revised draft finalised by the Agency in collaboration with Member States 5 December 2012 Revised draft agreed by ERMS FG 6 December 2012 Revised draft adopted by Executive Director as final 12 December 2012 Date for coming into effect 13 December 2012
[1] F. Haramburu,et al. Does age increase the risk of adverse drug reactions? , 2002, British journal of clinical pharmacology.
[2] J. Slattery,et al. Enhanced Paediatric Pharmacovigilance at the European Medicines Agency: A Novel Query Applied to Adverse Drug Reaction Reports , 2016, Pediatric Drugs.