Key Modules Overview:

1. Introduction to Drug Regulatory Affairs
   • Understand the role of Regulatory Affairs in the pharmaceutical industry and the responsibilities of regulatory professionals.
2. Drug Discovery & Development
   • Learn about the steps to market a drug, including Investigational New Drug Application (IND) and New Drug Application (NDA) processes.
3. Drug Approval Process
   • Explore the drug approval processes in India, the USA, Europe, and Australia.
4. Good Regulatory Practices (GRP)
   • Study the principles and significance of Good Regulatory Practices in detail.
5. Drug Registration Process
   • Understand the preparation of dossiers and the requirements for electronic and common technical documents (CTD).
6. Documents Required for Exporting Pharmaceuticals
   • Gain insights into the documentation necessary for exporting pharmaceutical products.
7. GMP and GMP Audit
   • Learn about Good Manufacturing Practices and the auditing processes to ensure compliance.
8. Work Opportunities in Regulatory Affairs & IPR Departments
   • Explore the roles of Regulatory Affairs professionals and prepare for career opportunities in this field.
9. Practicals
   • Engage in hands-on training for registration guidelines search and dossier preparation.

Unlock your potential in the dynamic world of Drug Regulatory Affairs and be at the forefront of transforming healthcare through effective regulatory practices!