Pharmaceutical Regulatory Affairs Course
This course equips you with essential skills in pharmaceutical regulatory affairs, covering GMP inspections, pharmacovigilance systems, marketing authorisation via CTD/eCTD dossiers, stability data analysis, and compliant promotional practices. You will learn to interpret regulatory data, manage compliance risks, respond effectively to authorities, and ensure patient safety in pharmaceutical operations across global frameworks.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
Gain practical skills in pharmaceutical regulatory affairs, including marketing authorisation processes, CTD/eCTD dossier preparation, GMP inspection standards, stability data requirements, pharmacovigilance systems with PSMF, and rules for compliant promotion and advertising to effectively manage risks and support regulatory compliance.
Elevify advantages
Develop skills
- Master regulatory dossiers including CTD/eCTD structure and approval processes.
- Develop GMP inspection skills to identify issues, evaluate CAPA, and record findings.
- Set up compliant pharmacovigilance systems, PSMF, and reporting mechanisms.
- Evaluate stability data per ICH guidelines for shelf-life and product labelling.
- Gain expertise in reviewing promotions to ensure compliant advertising claims.
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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