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Drug Regulatory Affairs Course

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

What will I learn?

This course equips you with hands-on skills to handle US and EU drug submissions, select ideal pathways, and create compliant CTD/eCTD dossiers. You will cover key CMC and bioequivalence topics, post-approval duties, pharmacovigilance, labelling requirements, inspection readiness, and smooth interactions with regulators for quicker approvals and sustained compliance.

Elevify advantages

Develop skills

  • Design US/EU generic pathways by selecting the best FDA or EMA route quickly.
  • Build strong CMC packages with quality, stability, and bioequivalence study data.
  • Compile CTD/eCTD dossiers by structuring Modules 1 to 5 for smooth approvals.
  • Handle interactions with agencies by confidently responding to FDA/EMA queries.
  • Manage post-approval tasks including pharmacovigilance, 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 chosen.
EmersonPolice Investigator
The course was essential to meet my boss's and the company's expectations.
SilviaNurse
Very great course. Lots of rich information.
WiltonCivil Firefighter

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