flexible workload of 4 to 360h
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 the best pathway, and prepare compliant CTD/eCTD dossiers. You will learn key aspects of CMC and bioequivalence, post-approval and pharmacovigilance duties, labelling rules, readiness for inspections, and how to interact effectively with authorities, enabling you to support quicker approvals and sustain compliance confidently.
Elevify advantages
Develop skills
- Design US/EU generic pathways: select the optimal FDA or EMA route quickly.
- Build CMC packages: develop strong quality, stability, and BE study data.
- Compile CTD/eCTD dossiers: organise Modules 1–5 for smooth approvals.
- Handle agency interactions: reply to FDA/EMA queries confidently.
- Manage post-approval: handle 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 workloadWhat our students say
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