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Safety Compliance
Session Chair(s)
Alan Hochberg
Principal Scientific Enablement Director, Scientific Enablement and Processes
Genentech, A Member of the Roche Group, United States
This session will provide an update on key topics related to compliance with pharmacovigilance regulations, including information on inspection findings and procedures in general and with a specific focus on risk management, as well as the broader compliance implications of Clinical Trial Regulation.
Learning Objective : Examine how a risk-based approach leads to more efficient PV; Identify the systems gaps that have been revealed by inspections; Describe practical ways to globally harmonize PV and GCP compliance; Assess MHRA inspection Metrics and find the prominent areas of the risk management system which lead to critical and major findings.
Speaker(s)
MHRA GPvP Inspections: Trends in Compliance and Evolution of Inspections
Mandy Budwal-Jagait, MSc
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of GCP and Lead Senior GCP Inspector
Clinical Trial Regulation is an Opportunity to Revisit Compliance at the Pharmacovigilance and GCP Interface
Shelley Gandhi, MSc
NDA Group, United Kingdom
Strategic Advisor, Pharmacovigilance and Drug Safety
Risk Management System: An Area of Specific Concern : Analysis of MHRA GPvP Inspection Metrics Reports from June 2009-March 2020
Garima Mishra, MPharm
APCER Life Sciences, India
Subject Matter Expert
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