Pharmacovigilance Agreements (PVAs): Guidance on the quality oversight and operational aspects

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.

Contents

Background/Purpose

Types of agreements  

  • Co-development arrangements 
  • Co-Marketing and Licensing  
  • Distribution and Wholesaler Agreements 
  • Manufacturing arrangements 
  • 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

Operational aspects  Quality oversight

  • PVA Compliance 
  • Point to consider when developing a quality oversight strategy  
  • Methods of quality oversight 
  • Questionaire assessment 
  • Conclusions 

Authors

RQA  Sandra Dunlavy, Astellas  Magda Daudin, Janssen  Andrew Cooper, GlaxoSmithKline  Kieran O’Donnell, TMC Pharma Thomas Henn, United Therapeutics Europe Ltd  JSQA  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. 

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