EU Health Policy and Regulatory Strategy
The EU Health Policy & Regulatory Strategy track is composed of sessions addressing regulations, guidelines, and guidances that govern biopharmaceutical, device product and companion diagnostics development, approval, and maintenance. Themes will commonly revolve around European Regulatory Changes and Impact on Global Development Strategies. As we are envisaging the revision of the EU Orphan Drug and Paediatric Regulations as well as the EU General Pharma Acquis, these aspects will be prominently featured during the meeting by addressing corresponding draft legal texts. Representatives from EMA, MHRA, European Health Authorities and other regulatory experts will provide updates, insights, and discussion on current issues through interactive forums.
Who is This Track Designed For?
This track and associated sessions will be designed for professionals involved or interested in EU Health Policy and in Regulatory Strategy.
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Senior Director, Head Europe Global Regulatory & Scientific Policy
Merck Healthcare KGaA, Germany
Regulatory Affairs, Director
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.