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Session 2: Business Partners Oversight
Session Chair(s)
Shahinaz Badr, PHARMD
Founder & Managing Director, Vigilance Gate FZ,LLC, 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)
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
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
Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, Switzerland
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
Elspeth McIntosh, MBA, RN
Director, Castle Pharmacovigilance Ltd, United Kingdom
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
Shahinaz Badr, PHARMD
Founder & Managing Director, Vigilance Gate FZ,LLC, United Arab Emirates
Challenges Met to Keep the Oversight in Terms of Legislations Changes
Gemma Jimenez Sese
Senior Director, Deputy EU QPPV, AstraZeneca, Spain
Challenges Met to Keep the Oversight in Terms of Legislations Changes
Dionne Usher
Associate Director, Office of the EU QPPV, Merck Sharp & Dohme Limited, United Kingdom
Challenges met in the PSMF, PSSF or different PSMFs involved, and how far can we go with auditing
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