Scientific Advice (SA) is one of the important interactions a developer can have with a regulatory agency (national or European level). It can facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients. In this session, we answer the questions on SA such as:
- When the developer can request a SA?
- What are the different SA procedures?
- Why request a SA?
- What’s the difference between a National Scientific Advice vs an EMA scientific Advice?
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Featured Speakers
Lise Merlay Barbin PhD, Eng.
Senior Director, Regulatory Science
As a Director, Regulatory Science, Lise manages projects from early stages of development to late clinical development phases and up…
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Peri Aghadiuno, MBBS, MRCOG
Senior Medical Director
As a Senior Medical Director at VCLS, Peri is responsible for providing input to, and critical review of, the clinical sections of a…
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