The main objective of this course to create awareness about regulatory affairs . This course contain following topics- 1. Introduction to the Regulation of Medical Devices 2. Regulatory Affairs for Human Medicinal Products (EU and US) 3. MRP – The Mutual Recognition Procedure 4. CTD – Preparing Submissions in the Common Technical Document Format 5. eCTD – Electronic Common Technical Document 6. DCP – The Decentralized Procedure 7. NDA – Submitting a New Drug Application: Obtain Approval to Market 8. How to Gain Approval to Market Generic Drugs 9. The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars)