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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)

Annex 16 QP Certification and Batch Release – Frequently Asked Questions – part 2

Posted by: and , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice
business woman studying some paperwork

In part 2 of our series on QP Certification and Batch Release we concentrate on the application of Annex 16 to Investigational Medicinal Products (IMPs)

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.