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Session 2: Business Partners Oversight
Session Chair(s)
Shahinaz Badr
Pharmacovigilance Consultant and PVQA Auditor - EMEA
Pharma Quality Europe, United Arab Emirates
Gemma Jimenez Sese
Senior Director, Deputy EU QPPV
AstraZeneca, Spain
NO SIZE FITS ALL: Mergers, acquisitions, joint ventures, Co-marketing, Co-Promotion or just distribution deals, are different business models for which QPPV is expected to have oversight whether in EU or outside EU regardless whether you are from a big or small company. This session will cover key aspects regarding business partners, from due diligence activities, establishment the appropriate PV agreements or KPIs to how to maximise PSMF use.
Speaker(s)
In case of mergers and acquisitions, joint venture … etc : examples of two of big pharma different corporate restructuring and the impact on the oversight starting with the due diligence and structuring of the SDEA
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
In case of mergers and acquisitions, joint venture … etc : examples of two of big pharma different corporate restructuring and the impact on the oversight starting with the due diligence and structuring of the SDEA
Willemijn van der Spuij, MSc
Switzerland
Executive Director, WorldWide Patient Safety International, Europe
Outsourcing and extended role of the EU QPPV which may not involve the integration of other PV systems into the company’s PV system but oversight as it is a different PV system: Small pharma example here with the EX-EU QPPV, different PSMF
Elspeth McIntosh, MBA, RN
Castle Pharmacovigilance Ltd, United Kingdom
Director
Challenges Met to Keep the Oversight in Terms of Legislations Changes
Shahinaz Badr
Pharma Quality Europe, United Arab Emirates
Pharmacovigilance Consultant and PVQA Auditor - EMEA
Challenges Met to Keep the Oversight in Terms of Legislations Changes
Gemma Jimenez Sese
AstraZeneca, Spain
Senior Director, Deputy EU QPPV
Challenges met in the PSMF, PSSF or different PSMFs involved, and how far can we go with auditing
Dionne Usher
Merck Sharp & Dohme Limited, United Kingdom
Associate Director, Office of the EU QPPV
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