2023-02-08

Unmet Medical Need: A Regulatory Perspective

Join us on Wednesday 22nd March 2023 at 13:00 GMT| 14:00 CET | 09:00 EDT, when Jan Sjöberg will discuss the regulatory perspective of unmet medical need as a key criterion for drug development.

An increasing number of advanced therapies and orphan drugs, targeting small patient populations, face challenges when aligning with the traditional drug development pathway. It means walking the tightrope between having early access to new medicines for patients who urgently need it while maintaining the rigorous control of safety and efficacy of the product throughout the approval process.

Addressing unmet medical need is a key criterion for medicine development and study design, however, a consensus on the definition of unmet medical need, does not exist.

During this webinar Jan will cover the implications of unmet medical need and the importance of its alignment in clinical development in relation to:

Conditional Marketing Authorisation (CMA)
Priority Medicines (PRIME) eligibility
Scientific Advice Working Party (SAWP)/Committee for Medicinal Products for Human Use (CHMP) advice

Author

Jan Sjöberg

NDA Advisory Board Member

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