Regulatory Strategy & EU Pharmaceutical Policy
EU Pharmaceutical Policy is striving to balance support for scientific innovation and investment in European R&D, while simultaneously addressing access, affordability and availability of medicines. In the context of the revision of the EU General Pharmaceutical Legislation as well as of the Orphan Drug and Paediatric Regulations, sessions in this track will focus on how the framework can be optimised to support regulatory science.
Who is This Track Designed For?
This track and associated sessions will be designed for regulatory strategy and policy professionals interested in exploring both the big picture on the evolution of the regulatory ecosystem and more focused sessions on key aspects of regulating the development of medicines.
Emma Du Four
Regulatory and R&D Policy Professional, United Kingdom
Senior Director, Government Affairs Strategy and Excellence
Bristol Myers Squibb, Belgium
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.