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Renaissance London Heathrow Hotel

Oct 10, 2018 8:00 AM - Oct 11, 2018 4:30 PM

Bath Road, Hounslow, Middlesex, TW6 2AQ, United Kingdom

2018 European Forum for Qualified Person for Pharmacovigilance (QPPV)

Session 6: Am I Compliant Enough?

Session Chair(s)

Angela  Van Der Salm, PHD, MSC

Angela Van Der Salm, PHD, MSC

Director PV, Managing partner, DADA Consultancy B.V., Netherlands

Elspeth  McIntosh, MBA, RN

Elspeth McIntosh, MBA, RN

Director, Castle Pharmacovigilance Ltd, United Kingdom

The actions required to demonstrate compliance may vary depending on company size, products and complexity of processes. This session will look at challenges and potential solutions for small/medium sized companies across a range of activities which affect QPPV oversight.

Speaker(s)

Peter  De Veene, MD

International Infrastructure Challenges (Small vs Large Company)

QPPV, MSD Belgium, Belgium

Angela  Van Der Salm, PHD, MSC

Small Pharma Challenges and Outsourcing

Director PV, Managing partner, DADA Consultancy B.V., Netherlands

Martijn  Van De Leur

Challenges in Compliance and Audits

Chief Commercial Officer, Biomapas, Lithuania

David  Stokes

Challenges in Computer System Validation

Director and Principal Consultant, Convalido, United Kingdom

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