Pharmacovigilance Agreements (PVAs): Guidance on the Quality Oversight and Operational Aspects
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The purpose of this booklet is to provide some guidance on the quality oversight and operational aspects of PVAs for professionals working in PV, Legal, Regulatory Affairs and QA departments.
The booklet aims to provide you with:
• An overview of the types of agreement • The items which you may need to consider when developing and implementing PVAs • The items to consider and to prioritise for QA oversight • A matrix of the typical clauses according to your agreement type.
Types of agreements
Co-Marketing and Licensing
Distribution and Wholesaler Agreements
Purchase agreements/tenders/charitable donations
Service level agreements
Business service providers for marketing related activities
Service providers for delegated PV activities or PV supporting functions
Collaboration arrangement with not-for-profit organisation
Point to consider when developing a quality oversight strategy
Methods of quality oversight
RQA Sandra Dunlavy, Astellas Magda Daudin, Janssen Andrew Cooper, GlaxoSmithKline Kieran O’Donnell, TMC Pharma Thomas Henn, United Therapeutics Europe Ltd