Pharmaceutical Regulatory Affairs Course
This course provides essential skills in pharmaceutical regulatory affairs, covering dossier preparation, GMP inspections, pharmacovigilance, stability analysis, and promotional compliance to ensure regulatory adherence and product safety.

flexible workload from 4 to 360h
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 international 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 regulators, and ensure safe, compliant products.
Elevify advantages
Develop skills
- Mastery of regulatory dossiers: structure, CTD/eCTD, and approval routes.
- GMP inspection abilities: identify shortcomings, evaluate CAPA, and record findings quickly.
- Setting up pharmacovigilance systems: create compliant PV, PSMF, and reporting processes.
- Evaluating stability data: analyse ICH outcomes for shelf-life and labelling.
- Expertise in promotional review: check claims, avoid off-label and noncompliant advertisements.
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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