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DIA 2021 Global Annual Meeting

Safety Compliance

Session Chair(s)

Alan M Hochberg

Alan M Hochberg

  • Principal Scientific Enablement Director
  • F. Hoffmann-La Roche, Switzerland
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)

Mandy Budwal-Jagait, MSc

MHRA GPvP Inspections: Trends in Compliance and Evolution of Inspections

Mandy Budwal-Jagait, MSc

  • GPvP Operations Manager and Lead Senior GCP Inspector
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Shelley Gandhi, MSc

Clinical Trial Regulation is an Opportunity to Revisit Compliance at the Pharmacovigilance and GCP Interface

Shelley Gandhi, MSc

  • Strategic Advisor, Pharmacovigilance and Drug Safety
  • NDA Group, United Kingdom
Garima Mishra, MPharm

Risk Management System: An Area of Specific Concern : Analysis of MHRA GPvP Inspection Metrics Reports from June 2009-March 2020

Garima Mishra, MPharm

  • Subject Matter Expert
  • APCER Life Sciences, India