Pharmacovigilance and Safety
This track provides an overview of the global regulatory environment for vigilance for medicinal products and medical devices. The focus is on pragmatic approaches for ensuring patient safety and ensuring that the patient voice is properly heard in the complex and evolving pharmacovigilance ecosystem. The forward-thinking sessions will address the complexities of operating in a global environment and how to apply new technologies and methods for streamlining pharmacovigilance systems and processes. This will help enhance patient safety as products become progressively more complex, new data sources drive new analytical techniques, regulatory requirements.
Who is This Track Designed For?
Anyone curious/interested, established professionals who are seeking to increase their network of like-minded colleagues; share their thoughts and practices with others; learn the most current regulatory views and gain practical knowledge in key areas in pharmacovigilance
The online program is now available. Explore the rich content we offer across 10 thought leadership tracks.
Topic Leaders
Francoise Dumas-Sillan
VP GPS TA ENDO-ONCO & EU QPPV
Ipsen, France
Phil Tregunno
Head of Vigilance Operations, Safety & Surveillance
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sina Schader
EU and UK QPPV
Abbvie, Germany
DIA Europe 2023 Highlights
It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.