from 4 to 360h flexible workload
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 global regulatory frameworks. You will learn GMP inspection requirements, stability data and quality standards, pharmacovigilance systems and PSMF, rules for compliant promotion and advertising, and enforcement mechanisms to manage risks, respond to authorities, and support safe, compliant products.
Elevify advantages
Develop skills
- Mastery of regulatory dossiers: structure, CTD/eCTD, and approval pathways.
- GMP inspection skills: identify deficiencies, evaluate CAPA, and document findings quickly.
- Setting up pharmacovigilance systems: develop compliant PV, PSMF, and reporting processes.
- Evaluating stability data: interpret ICH results 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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