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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Pharmacovigilance Inspections: Leveraging Inspection Intelligence as a Driver of Quality in Your Organization

Session Chair(s)

David  Fryrear, MS

David Fryrear, MS

Executive Vice President and Head of Quality Assurance

Astellas, United States

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 Objective : 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.

Speaker(s)

Bhawna  Rastogi, DrMed

Trend of Findings in Pharmacovigilance Inspections Conducted by Different Health Agencies

Bhawna Rastogi, DrMed

APCER Life Sciences, India

Associate Vice President

Anna  Adams, PhD, MSc

UK Pharmacovigilance Inspections: Inspection Readiness and Recent Inspection Findings

Anna Adams, PhD, MSc

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Senior GPvP Inspector, Inspection, Enforcement and Standards

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