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Pharmaceutical Regulatory Affairs Course

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

What will I learn?

Gain practical skills in pharmaceutical regulatory affairs, including marketing authorisation processes, CTD/eCTD dossier preparation, GMP inspection standards, stability data requirements, pharmacovigilance systems with PSMF, and rules for compliant promotion and advertising to effectively manage risks and support regulatory compliance.

Elevify advantages

Develop skills

  • Master regulatory dossiers including CTD/eCTD structure and approval processes.
  • Develop GMP inspection skills to identify issues, evaluate CAPA, and record findings.
  • Set up compliant pharmacovigilance systems, PSMF, and reporting mechanisms.
  • Evaluate stability data per ICH guidelines for shelf-life and product labelling.
  • Gain expertise in reviewing promotions to ensure compliant advertising claims.

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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