Healthcare GCP inspection findings andthe benefit risk balance-EMEA

1. D.Ibrahim Mahamoud AAPS June 2014 2. contents  General considerations  1. Ethics  2. General note on findings  3. Categorization of findings  4. Other considerations…

Documents Regulatory Requirements

Regulatory Requirements DIA, Clinical Forum, Dublin, 7 October 2013 Fergus Sweeney, Head, Inspections and Human Medicines Pharmacovigilance , European Medicines Agency Disclaimer…