from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The Drug Regulatory Affairs Course equips you with practical skills to handle US and EU submissions, select appropriate pathways, and prepare compliant CTD/eCTD dossiers. You will learn key aspects of CMC and bioequivalence, post-approval requirements, pharmacovigilance duties, labelling guidelines, inspection preparation, and effective engagement with regulatory authorities to facilitate quicker approvals and ensure sustained compliance confidently.
Elevify advantages
Develop skills
- Design US/EU generic pathways: choose optimal FDA or EMA route fast.
- Build CMC packages: craft robust quality, stability, and BE study data.
- Compile CTD/eCTD dossiers: structure Modules 1–5 for clean approvals.
- Handle agency interactions: respond to FDA/EMA queries with confidence.
- Manage post-approval: PV, variations, labelling and safety updates.
Suggested summary
Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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