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Regulatory Strategy & EU Pharmaceutical Policy

This track examines the regulations and policies governing biopharmaceutical product development, approval and maintenance. Sessions will explore how the European regulatory ecosystem is evolving and what those changes mean for global development strategies.

In the context of revisions to the EU General Pharmaceutical Legislation and the Orphan Drug and Paediatric Regulations, sessions will consider how the framework can support regulatory science and sustainable innovation. Representatives from the European Commission, EMA, national European health authorities and other regulatory stakeholders will share updates and insights through interactive discussions of current issues.

Who Is This Track Designed For?

This track is designed for regulatory strategy and policy professionals interested in the strategic implications of Europe’s evolving regulatory ecosystem and the key regulations affecting medicines development.

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