Regulatory Writing and Communication: Introductory
July 18, 2026 2026-07-20 16:30Regulatory Writing and Communication: Introductory
Regulatory Writing and Communication: Introductory
Build the foundation of regulatory writing, the disciplines of structure and evidence, Clinical Study Reports under ICH E3, the Common Technical Document and FDA briefing documents.
No prior Aleph course is required.
A regulatory submission is read long before it is approved. The quality of the writing, the discipline of structure, evidence, citation and clarity, determines an agency’s review speed and the tone of subsequent interactions.
This 16-hour Professional Certificate Course introduces the fundamentals of regulatory writing (scope, conventions, audiences), the structure and content of the Clinical Study Report under ICH E3, the Common Technical Document and its five modules under ICH M4 (with focus on the Module 2 Overviews and Summaries), and FDA Type A/B/C briefing documents.
The Introductory course prepares participants for the Advanced level (RAQ-660-A), where safety reports, plain-language patient labeling, advertising and promotion, and ethics in regulatory communication are developed in depth.
The Introductory course gives medical and regulatory writers and regulatory-affairs professionals the CSR and CTD foundation on which every submission document depends.
Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.
Tell us about your goals, audience, and timeline. Aleph University will follow up with information and a custom quote for individuals, teams, or organizations.
Professional development in medical devices, health technologies, regulatory affairs, and quality.
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