Log in
Choose your language

Drug Regulatory Affairs Course

Drug Regulatory Affairs Course
from 4 to 360h flexible workload
valid certificate in your country

What will I learn?

The Drug Regulatory Affairs Course provides 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 to support quicker approvals and maintain ongoing compliance confidently.

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.
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 the chosen one.
EmersonPolice Investigator
The course was essential to meet the expectations of my boss and the company where I work.
SilviaNurse
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