4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
The Drug Regulatory Affairs Course provides practical skills to navigate US and EU submissions, select the appropriate pathway, and prepare compliant CTD/eCTD dossiers. Learn CMC and bioequivalence essentials, post-approval and pharmacovigilance obligations, labelling 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 quickly.
- 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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