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Virtual Event

Nov 02, 2020 1:00 PM - Nov 04, 2020 4:25 PM

(Central Europe Standard Time)

4051 Basel, Switzerland

Pharmacovigilance Strategies Workshop

Session 5: Pharmacovigilance Inspections and Audits

Session Chair(s)

Mette  Stockner, MD

Mette Stockner, MD

Senior Pharmacovigilance Director

Savara ApS, Denmark

Audits and Inspections play an important role for the Pharmacovigilance System. In this session you will hear about the current trends in audit and inspection findings, some reflections on the challenges of organizational complexity, small/large, with outsourcing or in house operation, and the important interfaces between Pharmacovigilance and other functions in the companies. We will discuss some tips and tricks for remote audits and inspections and get the latest information from the MHRA Guidance on pharmacovigilance procedures. An interactive dialogue will allow participants to engage with the speakers and industry experts.

Speaker(s)

Louise  Mawer

Trends in audit findings

Louise Mawer

Mirabilitas Ltd, United Kingdom

Director

Rory  Littlebury

Inspection Findings: Recommendations from an Inspector

Rory Littlebury

GSK, United Kingdom

Safety Governance Director

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