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Pharmaceutical Regulatory Affairs Course

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

What will I learn?

This course equips you with current practical skills for handling marketing approvals, CTD/eCTD submissions, and worldwide regulatory standards. You will cover GMP inspection standards, stability testing data, quality controls, pharmacovigilance processes including PSMF, rules for compliant marketing and ads, plus enforcement methods to handle risks, engage regulators, and ensure product safety and compliance.

Elevify advantages

Develop skills

  • Master regulatory dossiers: CTD/eCTD formats and approval processes.
  • Excel in GMP inspections: identify issues, evaluate CAPA plans, and record outcomes quickly.
  • Set up pharmacovigilance: develop compliant PV systems, PSMF, and signal reporting.
  • Analyse stability data: apply ICH guidelines for shelf-life decisions and labels.
  • Review promotions expertly: check claims to avoid off-label or illegal 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 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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