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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
Sandra Dunlavy, Astellas
Magda Daudin, Janssen
Andrew Cooper, GlaxoSmithKline
Kieran O’Donnell, TMC Pharma Thomas Henn, United Therapeutics Europe Ltd
Tomoko Yanai, Santen Pharmaceutical Co., Ltd
Shigeo Suzuki, MSD K.K. Ayami Komatsu, Japan Tobacco INC.
Teiki Iwaoka, CAC Croit Corporation
Madoka Sasaki, Sumitomo Dainippon Pharma Co. Ltd.