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Essential Regulatory Documents and Regulatory Requirements for Biomedical P


Overview Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.

This session will cover various types of essential documentation, subject specific and non-subject specific, for clinical trials involving drugs, biologics and medical devices trials.

The course will help define what should be maintained at a research site and Sponsors to promote adequate and accurate documentation in compliance with current regulatory requirements. Current regulatory requirements and guidelines for records/reports handling, storage and retention will be discussed.

https://www.traininng.com/webinar/essential-regulatory-documents-and-regulatory-requirements-for-biomedical-products-200444live?upcomingevents-seo

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