- To enable the students to take an overview of the intellectual property and drug regulatory environment.
- To make them aware of the structure, functions and powers of drug regulatory bodies and intellectual property laws at various levels.
- To sensitise them about various pertinent issues facing drug regulation at the national, and international levels.
- To equip the students with knowledge about practical issues while working in the drug regulatory environment.
TENTATIVE DATE OF COMMENCEMENT:
20 January 2013
PART I: INTELLECTUAL PROPERTY (Following topics will be covered)
- Introduction to IP
- Cyber laws
- Industrial Designs
- Trade Secrets and other IPS
- Traditional Knowledge, Plant Varieties and Biodiversity
- Commerce of intellectual properties
PART II: DRUG REGULATORY(Following topics will be covered)
- The Drug Industry
- Evolution of Drug Regulation
- Drug Regulatory in the US
- Drug Regulatory in the EU
- Drug Regulatory in India-I
- Drug Regulatory in India-II
- WHO and ICH
- Issues related to drug regulation in the age of globalization
- Regulatory requirements [STUDY OF DOCUMENTS AND PROCEDURES]