flexible workload from 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 requirements and pharmacovigilance duties, labelling guidelines, readiness for inspections, and how to interact effectively with regulatory authorities, enabling you to support quicker approvals and sustain compliance with assurance.
Elevify advantages
Develop skills
- Design US/EU generic pathways: select the best 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 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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