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Session 5: Pharmacovigilance Inspections and Audits
Session Chair(s)
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
Director, Mirabilitas Ltd, United Kingdom
Trends in audit findings
Rory Littlebury
Head of PVSO and QPPV Office, GlaxoSmithKline (GSK), United Kingdom
Inspection Findings: Recommendations from an Inspector