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 the proper 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 facilitate quicker approvals and sustain compliance with assurance.
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 workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workloadWhat our students say
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