Legal and Regulatory Issues in Biotechnology

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Free Online Course: Legal and Regulatory Issues in Biotechnology provided by Swayam is a comprehensive online course, which lasts for 4 weeks long. The course is taught in English and is free of charge. Upon completion of the course, you can receive an e-certificate from Swayam. Legal and Regulatory Issues in Biotechnology is taught by Prof. Niharika Sahoo Bhattacharya.

Overview
  • 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

Syllabus
  • 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 secto