Parallel session 14:30 - 16:30

Regulatory innovation: advancing complex drug product approval

This session is a continuation from the morning session: Complex drug products: new insights in the development and production

Recent developments in innovative technologies like Advanced Therapy Medicinal Products (ATMPs) and Nano-medicines provide new opportunities to address the increasing demands of an aging population, as well as for diseases with high unmet medical needs.

Despite recent innovations and considerable research and development efforts there is clear mismatch between these research and development efforts and the number of approved products in the European Union. The road from development to approval pose many challenges for scientist, developers and regulators and ask for collaborative opportunities to meet those challenges, which we will discuss in two sessions.

Speakers will be announced shortly


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