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Pharmaceutical Regulatory Affairs Course

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

What will I learn?

The Pharmaceutical Regulatory Affairs Course equips you with practical, current skills to handle marketing authorisation, CTD/eCTD dossiers, and international regulatory systems. You'll learn GMP inspection standards, stability data and quality needs, pharmacovigilance setups and PSMF, rules for compliant promotion and advertising, and enforcement methods to manage risks, deal with authorities, and ensure safe, compliant products.

Elevify advantages

Develop skills

  • Mastery of regulatory dossiers: structure, CTD/eCTD, and approval processes.
  • GMP inspection abilities: identify issues, evaluate CAPA, and record findings quickly.
  • Setting up pharmacovigilance systems: create compliant PV, PSMF, and reporting procedures.
  • Evaluating stability data: analyse ICH outcomes for shelf-life and labelling.
  • Expertise in promotional review: check claims, avoid off-label and noncompliant advertising.

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 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 where I work.
SilviaNurse
Very great course. Lots of rich information.
WiltonCivil Firefighter

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