# Legal and Regulatory Issues in Biotechnology

- Institution: IIT Kharagpur
- Department: Law
- Teacher: Prof. Niharika Sahoo Bhattacharya
- Level: Undergraduate
- Language: English
- Subjects: Law
- Source: [NPTEL](https://nptel.ac.in/courses/129105005)
- Licence: [CC BY-NC-SA](https://nptel.ac.in/faq) (Non-commercial use only.)
- Syllabus: [at the source](https://nptel.ac.in/courses/129105005)
- Who can watch: Teens profiles and older (sources give no ratings; placed by Invisible Network from the source's own words)

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

1. [Lecture 1 : Biotechnology product development cycle and critical issues](https://invisiblenetwork.ai/learn/nptel/129105005/66fa3ff9adef) (YouTube)
2. [Lecture 2 : Biotechnology product development cycle and critical issues (continued)](https://invisiblenetwork.ai/learn/nptel/129105005/42549039a7cb) (YouTube)
3. [Lecture 3 : Ethics in Animal & Human Research](https://invisiblenetwork.ai/learn/nptel/129105005/608ba9d6f1f9) (YouTube)
4. [Lecture 4 : Ethics in Animal & Human Research: Code of ethics and regulation (continued)](https://invisiblenetwork.ai/learn/nptel/129105005/a229f8edfdea) (YouTube)
5. [Lecture 5 : Ethics in Stem Cell Research](https://invisiblenetwork.ai/learn/nptel/129105005/f9282573f2b0) (YouTube)
6. [Lecture 6 : Stem Cell Research in India](https://invisiblenetwork.ai/learn/nptel/129105005/5876e3462810) (YouTube)
7. [Lecture 7 : Patenting issues in biotechnology](https://invisiblenetwork.ai/learn/nptel/129105005/1b0240b910df) (YouTube)
8. [Lecture 8 : Patenting issues in biotechnology (continued)](https://invisiblenetwork.ai/learn/nptel/129105005/5a2c2cefdde8) (YouTube)
9. [Lecture 9 : Patenting issues in biotechnology (continued)](https://invisiblenetwork.ai/learn/nptel/129105005/57c1e7d2d367) (YouTube)
10. [Lecture 10 : IPR issues in Plant biotechnology](https://invisiblenetwork.ai/learn/nptel/129105005/c62790fabdc4) (YouTube)
11. [Lecture 11 : Regulatory Framework for Genetically engineered Plant](https://invisiblenetwork.ai/learn/nptel/129105005/c0724c841cbd) (YouTube)
12. [Lecture 12 : Cartagena Protocol](https://invisiblenetwork.ai/learn/nptel/129105005/6305aa062cc6) (YouTube)
13. [Lecture 13 : Regulatory approval process for Biopharmaceuticals](https://invisiblenetwork.ai/learn/nptel/129105005/27102f2d71ec) (YouTube)
14. [Lecture 14 : Regulatory approval process for Biopharmaceuticals and Biosimilars in US](https://invisiblenetwork.ai/learn/nptel/129105005/b00307298d23) (YouTube)
15. [Lecture 15 : Data exclusivity and Patent term extension](https://invisiblenetwork.ai/learn/nptel/129105005/d33c8f1558b2) (YouTube)
16. [Lecture 16 : Resource Sharing: material transfer agreement](https://invisiblenetwork.ai/learn/nptel/129105005/d90fd601a8ad) (YouTube)
17. [Lecture 17 : Technology transfer agreements and patents](https://invisiblenetwork.ai/learn/nptel/129105005/36cc5279969d) (YouTube)