- TypeWebinar
- Location New York, United States
- Date 11-08-2021
Medical/Healthcare/Hospital
OTHERS
Live Webinar: Scientific advice for medicinal products in the EU When: Wednesday August 11, 2021 - 03:00 PM Duration: 90 Minutes.
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Scientific advice is when the Regulatory Authorities gives advice to a company on the appropriate tests and studies in the development of a medicine. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.
Choosing the right procedure for scientific advice (at the European Medicines Agency or at the National Authorities in the EU) and preparing well for the procedure is very important to assure your development program meets the requirements of the Regulatory Authorities.
Areas covered in this webinar
Introduction
Scientific advice at the EMA
Qualification of novel methodologies
Parallel scientific advice: EMA and FDA
Parallel scientific advice: EMA and HTA bodies
National scientific advice