Regulatory Affairs - eCTD Submission Gateways for FDA and EMA, and ICH-M8 (Pharmaceutical Sciences and Health Care products). Peivand Pirouzi, Ph.D.

Discover the intricacies of submission gateways for regulatory compliance with the FDA and EMA in this comprehensive guide. In this video, we delve into the ICH-M8 guidelines, exploring how they streamline electronic submission processes for pharmaceutical and biotechnological products. Learn about:

Key features of the FDA’s Electronic Submission Gateway (ESG) and the EMA’s eSubmission Gateway/Web Client.
The role of ICH-M8 in harmonizing electronic standards across regulatory agencies.