The Regulatory Strategy & EU Pharmaceutical Policy track is composed of sessions addressing regulations and policies governing biopharmaceutical product development, approval, and maintenance. Themes will revolve around evolution of the European regulatory ecosystem and impacts for global development strategies. In the context of revision of the EU General Pharmaceutical Legislation as well as the Orphan Drug and Paediatric Regulations, sessions will focus on how the framework can be optimised to support regulatory science and the sustainability of innovation. Representatives from the European Commission, EMA, National European Health Authorities and other regulatory stakeholders will provide updates, insights, and discussion on current issues through interactive forums.

Who is This Track Designed For?

Regulatory strategy and policy professionals interested in exploring both the strategic implications of the evolving regulatory ecosystem as well as focused sessions on key aspects of regulation impacting the development of medicines.