Pharmaceutical Regulatory Affairs Course
Gain essential skills in pharmaceutical regulatory affairs, covering GMP inspections, pharmacovigilance systems, marketing authorisations, promotional compliance, stability data analysis, and risk management. Learn to interpret regulations, respond to authorities, and safeguard patient safety in everyday pharmacy operations across global markets.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This course equips you with current practical skills for handling marketing approvals, CTD/eCTD submissions, and worldwide regulatory standards. You will cover GMP inspection standards, stability testing data, quality controls, pharmacovigilance processes including PSMF, rules for compliant marketing and ads, plus enforcement methods to handle risks, engage regulators, and ensure product safety and compliance.
Elevify advantages
Develop skills
- Master regulatory dossiers: CTD/eCTD formats and approval processes.
- Excel in GMP inspections: identify issues, evaluate CAPA plans, and record outcomes quickly.
- Set up pharmacovigilance: develop compliant PV systems, PSMF, and signal reporting.
- Analyse stability data: apply ICH guidelines for shelf-life decisions and labels.
- Review promotions expertly: check claims to avoid off-label or illegal advertising.
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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