This white paper provides insight into considerations when outsourcing Qualified Person for Pharmacovigilance (QPPV) services. It also touches upon potential challenges with oversight of the Marketing Authorization Holder (MAH) pharmacovigilance system.
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Case Study
PRA Leads Novel Multiple Myeloma Drug Development
PRA Health Sciences supported 2 multiple myeloma clinical trials, a Phase III and a “rollover,” for a large biotech client. This management contract…
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Newsletter
Pharmacovigilance Nugget #3 The Challenges of Effective PSMF Maintenance - December 2018
The Pharmacovigilance System Master File (PSMF) is a legal requirement in the European Union (EU). A PSMF shall describe the pharmacovigilance (PV)…
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White Paper
Sponsor and CRO Pharmacovigilance and Safety Alliances
Outsourcing pharmacovigilance is a standard business practice in a rapidly expanding market segment. In this new whitepaper, PRA’s Sabine Richter…
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