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Renaissance London Heathrow Hotel

10 oct 2018 8:00 a.m. - 11 oct 2018 4:30 p.m.

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)

Peter De Veene, MD

MSD Belgium, Belgium

GQPPV

Angela  Van Der Salm, PhD, MSc

Small Pharma Challenges and Outsourcing

Angela Van Der Salm, PhD, MSc

DADA Consultancy B.V., Netherlands

Director PV, Managing partner

Martijn  Van De Leur

Challenges in Compliance and Audits

Martijn Van De Leur

Biomapas, Netherlands

COO

David  Stokes

Challenges in Computer System Validation

David Stokes

Convalido, United Kingdom

Director and Principal Consultant

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