Pharmaceutical Regulatory Affairs Course
Master key pharmaceutical regulatory affairs skills—from GMP inspections and pharmacovigilance to marketing authorization and compliant promotion—and learn to interpret data, manage risk, and protect patient safety in real-world pharmacy practice.

flexible workload from 4 to 360h
valid certificate in your country
What will I learn?
The Pharmaceutical Regulatory Affairs Course gives you practical, up-to-date skills to navigate marketing authorization, CTD/eCTD dossiers, and global regulatory frameworks. Learn GMP inspection expectations, stability data and quality requirements, pharmacovigilance systems and PSMF, compliant promotion and advertising rules, and enforcement tools so you can manage risk, respond to authorities, and support 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 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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