DRUG REGULATORY AFFAIRS (GMP)

This comprehensive course on Drug Regulatory Affairs is designed to provide a complete understanding of the global regulatory frameworks that govern the pharmaceutical industry. It is ideal for students, industry professionals, and aspiring regulatory specialists who want to learn how drugs are developed, approved, and monitored for safety and effectiveness.
Key Topics:

✅Introduction to Regulatory Affairs: Understand the role of regulatory professionals in drug development and compliance.

✅Drug Development Process: Learn all stages from discovery to post-marketing and how regulations apply at each stage.

✅Major Global Regulatory Authorities: Explore roles of FDA, EMA, PMDA, MHRA, TGA, CDSCO, Health Canada, and NMPA.

✅Regulatory Submission Types: Understand NDA, ANDA, BLA, IND, MAA, and other global submission formats.

✅Common Technical Document (CTD/eCTD): Learn how to structure and prepare regulatory dossiers for global agencies.
✅Clinical Trials Oversight: Understand trial phases, protocols, informed consent, and GCP principles

✅Labeling and Advertising Regulations: Learn about compliant drug labeling, packaging, and promotional material.
✅Post-Marketing Surveillance & Pharmacovigilance: Monitor drug safety and manage adverse event reporting after approval.
✅Inspections and Compliance: Prepare for FDA, EMA, and other audits with best practices and documentation.
✅Regulatory Affairs for Biologics & Medical Devices: Special regulatory considerations for vaccines, biotech products, and devices.
✅Emerging Trends & Harmonization: Keep up with global harmonization, AI in regulatory affairs, and digital health regulations.