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Drug Regulatory Affairs Course

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

What will I learn?

This Drug Regulatory Affairs Course equips you with hands-on skills to handle US and EU regulatory submissions, select appropriate pathways, and create compliant CTD/eCTD dossiers. You will cover key areas like CMC and bioequivalence basics, post-approval duties, pharmacovigilance, labelling guidelines, inspection readiness, and smooth interactions with authorities for quicker approvals and sustained compliance.

Elevify advantages

Develop skills

  • Design US and EU generic drug pathways by selecting optimal FDA or EMA routes quickly.
  • Prepare comprehensive CMC packages with strong quality, stability, and bioequivalence study data.
  • Assemble CTD and eCTD dossiers by organising Modules 1 to 5 for smooth approvals.
  • Manage interactions with regulatory agencies by confidently responding to FDA and EMA queries.
  • Oversee post-approval activities including pharmacovigilance, 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 of 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 rich information.
WiltonCivil Firefighter

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