from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The Drug Regulatory Affairs Course gives you practical skills to navigate US and EU submissions, choose the right pathway, and prepare compliant CTD/eCTD dossiers. Learn CMC and bioequivalence essentials, post-approval and pharmacovigilance obligations, labeling rules, inspection readiness, and effective authority interactions so you can support faster approvals and maintain ongoing compliance with confidence.
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, labeling 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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