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ON DEMAND - Pharmacovigilance Inspections: Leveraging Inspection Intelligence as a Driver of Quality in Your Organization
Session Chair(s)
David Fryrear, MS
Chief Quality Officer
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)
Trend of Findings in Pharmacovigilance Inspections Conducted by Different Health Agencies
Bhawna Rastogi, DrMed
APCER Life Sciences, India
Associate Vice President
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