Good pharmacovigilance practice

MHRA GPvP Inspectorate Guide to Marketing Authorisation Holder Considerations for Agreements with Pharmacovigilance System Service Providers

The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much as any other. This blog expands upon the areas identified as problematic for MAHs and service providers and provides points to consider when producing contracts and agreements text.

PIC/S - Press release and news of TFDA hosted meetings and seminar, September 2017

From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)