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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)

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Session 7: Are You Compliant Enough? - Audits, Inspections and QMS

Session Chair(s)

Barbara De Bernardi, MD

Barbara De Bernardi, MD

EUQPPV Vice President - Head of Global QPPV Office, Pfizer S.r.l., Italy

Helen Powell

Helen Powell

Principal Consultant, NDA Regulatory Science Ltd, United Kingdom

The QPPV role includes oversight over the functioning of the PV system in all relevant aspects to ensure effective compliance with applicable EU legislation is maintained. However, distilling out what is truly required out from the ‘nice to have’ or from subjective interpretations is key to avoid allocation of valuable resources without real gain. This session will focus on current challenges with compliance interpretation and implementation from the perspectives of inspectors, companies and auditors

Speaker(s)

Joanna Harper

Joanna Harper

Expert Inspector, GPvP, Inspectorate, Enforcement and Standards, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Margaret Anne Walters

Margaret Anne Walters

Deputy EU Qualified Person for Pharmacovigilance, Merck, Sharp & Dohme Ltd, United Kingdom

Panel Discussion with Q&A

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