Log in
Choose your language

Drug Regulatory Affairs Course

Drug Regulatory Affairs Course
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 workload
Workload: between 4 and 360 hours

What our students say

I was just promoted to Intelligence Advisor for the Prison System, and the course from Elevify was crucial for me to be chosen.
EmersonPolice Investigator
The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Very great course. Lots of valuable information.
WiltonCivil Firefighter

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