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Wednesday, June 22 • 9:15am - 10:15am
#309: Pharmacovigilance Quality: Key Considerations

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-602-L04-P ; CME 1.00; RN 1.00

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. The MHRA’s GPvP inspection programme, will be presented. This will include approaches to inspection since the COVID-19 pandemic. The MHRA’s revised inspection model will be outlined, which incorporates targeted inspections that focus on particular areas of pharmacovigilance systems, products, and non-interventional studies. In addition, trends in GPvP inspection findings will be presented. With the rise in faster, more streamlined development of medicines, post authorisation safety studies become a key mechanism for the regulatory to understand the long-term safety profile of a new medicine. The MHRA GPvP inspectorate has included inspection of non-interventional PASS within its inspection programme and will discuss case studies from recent inspection findings. The important of data integrity and the study risk assessment will be discussed for NI-PASS involving primary data collection and how this important process would feed into other operational plans for the management and conduct of the study reporting or data and the important of the data integrity lifecycle will also be discussed.

Learning Objectives

Identify the principles of the MHRA’s risk-based GPvP inspection programme and learn about trends in GPvP inspection findings; Discuss the MHRA Pharmacovigilance Inspectorates experience of inspecting NI-PASS, including regulatory requirements for conducting NI-PASS and case studies from recent inspection findings; Discuss the the regulatory requirements for inspections conducted in the UK.

Chair

David Fryrear, MS

Speaker

FDA Good Pharmacovigilance Inspection Practice: FDA REMS, PADE and PMR Programs
Haley H Seymour, MS

MHRA Good Pharmacovigilance Practice (GPvP) Inspection Approaches and Metrics: MHRA GPvP NI-PASS Inspection Experience - The Importance of A Study Risk Assessment
Sophie Radicke, MSc



Speakers
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 Sophie Radicke

Sophie Radicke

Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Sophie is a senior pharmacovigilance inspector at the MHRA with 4.5 years' experience in leading complex and technically diverse inspections. In addition, she is regularly involved in the training and mentoring of trainee inspectors as well as stakeholder engagement and education... Read More →
avatar for Haley Seymour

Haley Seymour

Consumer Safety Officer, OSI, OC, CDER, FDA, United States
Haley Seymour earned her Bachelor of Science degree from Howard University in Clinical Laboratory Science and her Master of Science in Bioscience Regulatory Affairs from Johns Hopkins University. She joined the Food and Drug Administration (FDA) in 2009 as a Regulatory Project Manager... Read More →


Wednesday June 22, 2022 9:15am - 10:15am CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  08: RD Quality-Compliance, Session |   01: ClinSafety-PV, Session