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Thursday, June 18 • 5:00pm - 6:00pm
#544 OD: ON DEMAND - Pharmacovigilance Inspections: Leveraging Inspection Intelligence as a Driver of Quality in Your Organization

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Component Type: Session
Level: Intermediate

As the expectations for an organization’s pharmacovigilance system and the supporting quality management system rise, so does the scrutiny of them through inspections by regulatory agencies. Inspections are a necessary check of the systems’ effectiveness, but can be a source of anxiety. Understanding expectations in the inspections not only provides confidence for the actual inspection event itself, but also supports excellence in activities that are conducted every day. This session will provide insight on approaches to inspection preparation and management, recent areas of inspection focus, and ideas on improving quality practices with the objective of leading to a continuous state of inspection readiness.

Learning Objectives

Describe key areas of current inspection focus; Identify best practices for preparation and management of inspections; Recognize how lessons from inspections can inform practices in your organization and enhance day-to-day execution; Discuss how obtaining and sharing knowledge about inspections and inspection outcomes can support a culture of quality across the organization.


David William Fryrear, MS


Trend of Findings in Pharmacovigilance Inspections Conducted by Different Health Agencies
Bhawna Rastogi, DrMed

UK Pharmacovigilance Inspections: Inspection Readiness and Recent Inspection Findings
Anna Adams, PhD, MSc

avatar for David Fryrear

David Fryrear

Executive Vice President and Head of Quality Assurance, Astellas, United States
David Fryrear, M.S., is Executive Vice President and Head of Quality Assurance for Astellas. He has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development and commercialization... Read More →
avatar for Preeti Verma

Preeti Verma

Head of Delivery, Drug Safety Operations, Bioclinica
Dr. Preeti Verma is an MS in OBG with over 15 years of experience in Medicine and PVG. She is Head of Operations and Delivery,drug safety, MICC and regulatory affairs.Prior, to this, she was she Associate Vice President, Pharmacovigilance Operations at APCER.She has experience in... Read More →
avatar for Anna Adams

Anna Adams

Senior GPvP Inspector, Inspection, Enforcement and Standards, Medicines and Healthcare products Regulatory Agency (MHRA)
Anna joined the MHRA as a Pharmacovigilance Inspector at the start of 2016. Since then, she has inspected the pharmacovigilance systems of all types of pharmaceutical organisations from large innovator firms, to small biotech start-ups, to international organisations with established... Read More →
avatar for Bhawna Rastogi

Bhawna Rastogi

Associate Vice President, Pharmacovigilance, APCER Life Sciences
Bhawna Rastogi is a dynamic professional with 19 years of clinical and industry experience. She is a trained physician and was in clinical practice before joining pharmaceutical industry. She is currently associated with APCER Life Sciences as an Associate Vice President-Pharmaco... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044