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Good Clinical Practice & Pharmacovigilance Compliance Workshop -Tuesday, 13 February to Thursday, 15 February 2024 (EST)
Bookings are open for the upcoming hybrid Good Clinical Practice & Pharmacovigilance Compliance Workshop, in partnership with the US Food and Drug Administration (FDA) and Health Canada (HC), presented by CDER Small Business and Industry Assistance (SBIA).
This three-day workshop will focus on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post pandemic world.
Days One & Two: We will discuss continuing developments in decentralised trials and innovative technologies used in clinical trials and the importance of implementing quality management and data governance strategies that are proportionate to the risks to trial participant safety and data reliability.
Day Three AM: dedicated to the conduct of bioequivalence (BE) studies. Regulators will provide their perspectives on common issues and challenges in the conduct of the clinical and bioanalytical components of BE studies and provide important updates on guidance and inspection activities.
Day Three PM: We will discuss insights into key pharmacovigilance (PV) compliance topics. The audience will have the opportunity to hear first-hand from regulators about regulatory updates and ongoing collaborative efforts among the international regulatory agencies by conducting and observing inspections, sharing inspection information, and developing policy.
We look forward to welcoming you at the event either:
- In person at the Hotel at the University of Maryland, College Park, Maryland, USA
- Virtually online.
Should you have any queries concerning the event, please email conferences@mhra.gov.uk
Conferences and Events Team
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