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Session 2: Regulatory Horizons: Key Updates on the Latest Inspection Requirements, AI Integration in Device Vigilance, and Recent Changes to CTR for Medical Devices
Session Chair(s)
Sophie Radicke, MSC
Head of GPvP and Senior Pharmacovigilance Inspector
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Session Overview: This session will focus on upcoming MHRA regulatory changes and guidances. Key topics will include decentralized manufacturing, upcoming CTR guidance, PMS guidance for medical devices, and insights on the AI pilot for medical devices. QPPVs will have the opportunity to hear from MHRA representatives and discuss the implications of these developments on their roles and responsibilities.
Speaker(s)
General MHRA GVP Inspection Updates: New Developments and Focal Areas
Claire Longman, MSC
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Pharmacovigilance Inspector
General MHRA GVP Inspection Updates: New Developments and Focal Areas
Sophie Radicke, MSC
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of GPvP and Senior Pharmacovigilance Inspector
Decentralized Manufacturing (Point-of-Care) Guidance
Claire Longman, MSC
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Pharmacovigilance Inspector
Updates on Clinical Trial Regulation (CTR) Guidance
Rachel Mead
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
GCP Inspector
AI in Medical Devices: Lessons from the MHRA Pilot
Jincy Robin
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
AI Airlock Project Support Officer Innovation & Compliance
PMS Guidance for Medical Devices: What You Need to Know
James Whitehead, MBA, MSC
Visiting Lecturer - Pharmacovigilance MSc Course, University of Hertfordshire, United Kingdom
Former Senior Director Device & Digital Safety - AstraZeneca