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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 Patient Safety, 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)
Sarah Gomersal
GPvP Inspector , Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
MHRA Inspections Expectations
Himal Makwana
Head of Defective Medicines, MHRA, United Kingdom
MHRA Defective Medicines Update and Expectations
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