Course12910500517 lectures
Legal and Regulatory Issues in Biotechnology
Prof. Niharika Sahoo Bhattacharya · IIT Kharagpur
About
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
Prerequisites: anyone who is interested to know the legal aspects of biotechnology industryINDUSTRY SUPPORT : Pharmaceutical / agro-biotech / environmental biotech companies
Lectures
Week 1:
- Lecture 1 : Biotechnology product development cycle and critical issues
- Lecture 2 : Biotechnology product development cycle and critical issues (continued)
- Lecture 3 : Ethics in Animal & Human Research
- Lecture 4 : Ethics in Animal & Human Research: Code of ethics and regulation (continued)
- Lecture 5 : Ethics in Stem Cell Research
- Lecture 6 : Stem Cell Research in India
Week 2:
- Lecture 7 : Patenting issues in biotechnology
- Lecture 8 : Patenting issues in biotechnology (continued)
- Lecture 9 : Patenting issues in biotechnology (continued)
- Lecture 10 : IPR issues in Plant biotechnology
Week 3:
- Lecture 11 : Regulatory Framework for Genetically engineered Plant
- Lecture 12 : Cartagena Protocol
- Lecture 13 : Regulatory approval process for Biopharmaceuticals
- Lecture 14 : Regulatory approval process for Biopharmaceuticals and Biosimilars in US
- Lecture 15 : Data exclusivity and Patent term extension
Week 4:
Syllabus and materials
At NPTEL, as the course publishes them.
Credits and licence
- Institution
- IIT Kharagpur
- Department
- Law
- Teacher
- Prof. Niharika Sahoo Bhattacharya
- Level
- Undergraduate
- Language
- English
- Subjects
- Law
- Source
- NPTEL
- Licence
- CC BY-NC-SA, as NPTEL states it. Non-commercial use only. NPTEL's terms
- Attribution
- NPTEL states: "Distributed under Creative Commons Attribution-ShareAlike / CC BY - NC - SA", beside a BY-NC-SA badge.
- Who can watch
- NPTEL gives no rating. Invisible Network shows it to Teens profiles and older, judged from what the source says about it. How courses are placed