Pharmaceutical Regulatory Affairs Course
This course provides essential skills in pharmaceutical regulatory affairs, covering dossier preparation, GMP inspections, pharmacovigilance, stability data, and promotional compliance to ensure safe and effective product marketing worldwide.

from 4 to 360h flexible workload
valid certificate 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 worldwide 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 back safe, compliant products.
Elevify advantages
Develop skills
- Regulatory dossier mastery: structure, CTD/eCTD, and approval pathways.
- GMP inspection skills: spot deficiencies, assess CAPA, and document findings fast.
- Pharmacovigilance system setup: build compliant PV, PSMF, and reporting flows.
- Stability data evaluation: interpret ICH results for shelf-life and labelling.
- Promotional review expertise: vet claims, prevent off-label and noncompliant ads.
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.What our students say
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