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 appropriate pathway, and prepare compliant CTD/eCTD dossiers. You will learn essentials of CMC and bioequivalence, post-approval and pharmacovigilance requirements, labelling rules, inspection readiness, and effective interactions with authorities, enabling you to support quicker approvals and sustain ongoing compliance confidently.
Elevify advantages
Develop skills
- Design US/EU generic pathways: select the best FDA or EMA route swiftly.
- 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 with assurance.
- 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 workload.What our students say
FAQs
Who is Elevify? How does it work?
Do the courses have certificates?
Are the courses free?
What is the course workload?
What are the courses like?
How do the courses work?
What is the duration of the courses?
What is the cost or price of the courses?
What is an EAD or online course and how does it work?
PDF Course
