New EU directives were put in force in 2012 and compliance has become an issue. Last year saw 19 companies cited for “critical pharmacovigilance failures.” New directives were also recently adopted on postmarket studies as well as a rule on monitoring medical literature.
Elisabethann Wright will cover the following issues:
•Periodic Safety Update Reports — what they must contain, and how frequently they must be issued
•Marketing authorization — the difference between getting it and renewing it
•The new rules on post-authorization efficacy studies
•The powers of the Pharmacovigilance Risk Assessment Committee and their relationship with the Committee on Human Medicinal Products
•The significance of the “Black Triangle”
•The EMA’s “GVPs” — Good Pharmacovigilance Practices — 12 parts out already, 3 more expected this year