Pharmaceutical Regulatory Affairs Course
This course equips professionals with essential skills in regulatory affairs for the pharmaceutical industry, covering dossier preparation, inspections, pharmacovigilance, stability testing, and promotional compliance to ensure safe and regulatory-compliant products.

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 authorization, CTD/eCTD dossiers, and international regulatory systems. Gain knowledge on 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 regulators, and back safe, rule-following 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 are saying
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