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Renaissance London Heathrow Hotel

2018 年 10 月 10 日 8:00 上午 - 2018 年 10 月 11 日 4:30 下午

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

Peter De Veene, MD

QPPV, MSD Belgium, Belgium

International Infrastructure Challenges (Small vs Large Company)

Angela  Van Der Salm, PHD, MSC

Angela Van Der Salm, PHD, MSC

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

Small Pharma Challenges and Outsourcing

Martijn  Van De Leur

Martijn Van De Leur

Chief Commercial Officer, Biomapas, Lithuania

Challenges in Compliance and Audits

David  Stokes

David Stokes

Director and Principal Consultant, Convalido, United Kingdom

Challenges in Computer System Validation

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