4 to 360 hours of flexible workload
certificate valid 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 appropriate pathway, and prepare compliant CTD/eCTD dossiers. Gain knowledge on CMC and bioequivalence fundamentals, post-approval and pharmacovigilance requirements, labelling regulations, inspection preparedness, and effective engagement with authorities to facilitate quicker approvals and sustain compliance assuredly.
Elevify Advantages
Develop Skills
- Design US/EU generic pathways: select the best FDA or EMA route swiftly.
- Build CMC packages: develop solid 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: 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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