Pharmacovigilance & Safety
This track provides an overview of and insight to the global safety environment 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 safety 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 safety 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 safety professionals who are seeking to increase their network of like-minded colleagues; share their thoughts and practices with others; learn the most current safety regulatory views and gain practical knowledge in key areas in pharmacovigilance.
Topic Leaders
Esther-De-Vries
Pharmacovigilance Assessor
CBG-MEB, Netherlands
James Whitehead
Global Director, HTA Policy
AstraZeneca, United Kingdom
Key Topics
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Day 1: Tuesday, March 12th
Risk Minimisation Measures: Future Collaborative Solutions in Europe
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Day 2: Wednesday, March 13
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Day 3: Thursday, March 14th, Hall 300
Introduction: Landscape assessment of the use of medicines in pregnancy and breastfeeding
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.