Pharmaceutical Regulatory Affairs Course
This course equips professionals with essential skills in pharmaceutical regulatory affairs, covering dossier preparation, GMP inspections, pharmacovigilance, stability testing, and compliant promotional practices to ensure global compliance and product safety.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The Pharmaceutical Regulatory Affairs Course provides practical, current skills to handle marketing authorisation, CTD/eCTD dossiers, and worldwide regulatory systems. You will 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, reply to 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 labeling.
- 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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