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Good pharmacovigilance practice

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

Posted by: , Posted on: - Categories: Compliance matters, Good pharmacovigilance practice
A light bulb within a thought bubble

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

PIC/S walking stick

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)

Do wholesale distributors require pharmacovigilance agreements?

Flip chart with the word compliance on, in the middle of a table

Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.

Too much pressure: a behavioural approach to Data Integrity (Part 2)

Chemist wearing safety glasses and using a tablet

The first post in this series described the importance of organisational behaviour on the success of data integrity control measures.  Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.