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Indian Institute of Technology, Kharagpur

Legal and Regulatory Issues in Biotechnology

Indian Institute of Technology, Kharagpur and NPTEL via Swayam


a) This course describes the convergence of scientific, regulatory, and commercial factors that drive the biotechnology industry.b) Equip students to understand the development cycle of a biotechnology derived product from legal and regulatory perspective.c) This course will introduce students to the interrelated fields of patent law, regulatory law, and contract law that are vital to the biotech and biopharmaceutical sectors.d) The course will present core concepts in a way that permits students to use them throughout their corporate, academic, and government careers.e) Create human resource with basic understanding of biotechnology and law which will contribute towards greater protection and commercialization of inventions.INTENDED AUDIENCE : Students, researchers, industry professionals from Law or biotechnology/life science/pharmaceutical science discipline (B.Tech, M.Tech, LLB, LLM, PhD scholars)PREREQUISITES : Bachelor degree students Prerequisite: anyone who is interested to know the legal aspects of biotechnology industryINDUSTRY SUPPORT : Pharmaceutical / agro-biotech / environmental biotech companies


Week-1 : Regulation of Biotechnology Research
Week-2 : Intellectual Property Rights and Life sciences (Agriculture, Pharma, Biotech) Week-3 : Biotech Product commercialization: Regulatory Approval Process
Week-4 : Understanding technology transfer in biotech sector

Taught by

Prof. Niharika Sahoo Bhattacharya

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