GCP & Pharmacovigilance Compliance | D1S01 - Updates: ICH E6(R3) Good Clinical...
48:43
YouTubeU.S. Food and Drug Administration
GCP & Pharmacovigilance Compliance | D1S01 - Updates: ICH E6(R3) Good Clinical...
These presentations provided a general overview of ICH E6 and explained why changes were made from ICH E6(R2) to E6(R3). This session covered changes to the principles and highlighted Annex 1 updates regarding investigator and sponsor responsibilities. MHRA consultation responses were discussed along with data governance changes, Appendix C's ...
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