Regulatory CMC submissions are moving from long PDF documents towards structured, reusable data. This self-paced course explains why that shift is happening, who benefits, and how the main initiatives fit together: ICH M4Q(R2), ICH M16, FDA PQ/CMC, KASA, FDA Elsa and HALO, and related EMA work.

In six short chapters you will learn how the CTD quality section is being revised, how a value in a PDF becomes a data element, how FDA structures quality assessment, and how ready your own organisation is for structured CMC submissions.

Who it is for: regulatory affairs, CMC, quality and data professionals in pharma and biotech with 0 to 10 years of experience. Level: beginner to intermediate.

What you get: six video lessons, reading summaries and key takeaways, short chapter quizzes, a one-page cheat sheet per chapter, a glossary, a worked case study (RegAtrium Therapeutics and RAG-101), an optional readiness assignment, a list of official ICH, FDA and EMA sources, a final assessment and a certificate of completion (70 percent pass mark).

Several of these initiatives are still evolving. Where a status may change, the course says so. Always check the latest official guidance.