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Session 4: MHRA Updates
Session Chair(s)
Sarah Gomersal
GPvP Inspector
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Helen Fiddes
Head of Country Pharmacovigilance, UK and Ireland
Bristol-Myers Squibb, United Kingdom
Hear from the MHRA on recent inspection trends and approaches to inspection conduct. An overview of the requirements of the role of the UK National Contact Person (NCP) for pharmacovigilance will be shared along with specific expectations from inspectors.
A wider update of the MHRA will also be provided informing attendees on changes to the setup of pharmacovigilance activities and outlining responsibilities.
Speaker(s)
MHRA Inspections Expectations
Sarah Gomersal
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
GPvP Inspector
MHRA Defective Medicines Update and Expectations
Himal Makwana
MHRA, United Kingdom
Head of Defective Medicines
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