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

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
The Pharmaceutical Regulatory Affairs Course gives you practical, up-to-date skills to navigate marketing authorisation, 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 labelling.
- 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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