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

4 to 360 hours 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 international regulatory systems. Gain knowledge of 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, compliant products.
Elevify advantages
Develop skills
- Regulatory dossier expertise: structure, CTD/eCTD, and approval processes.
- GMP inspection abilities: identify issues, evaluate CAPA, and record findings quickly.
- Pharmacovigilance system establishment: create compliant PV, PSMF, and reporting procedures.
- Stability data assessment: analyse ICH outcomes for shelf-life and labelling.
- Promotional review proficiency: check claims, avoid off-label and noncompliant promotions.
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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