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Regulatory Affairs - eCTD Submission Gateways for FDA and EMA, and ICH-M8 (Pharmaceutical Sciences and Health Care products). Peivand Pirouzi, Ph.D.
8 months ago
25
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.
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