At the end of this course, the students; 1) Distinguish knowledge of biosafety and risk assessment of products derived from recombinant DNA research and environment release of genetically modified organisms, national and international regulations. 2) Analyze ethical aspects related to biological, biomedical, health care and biotechnology research. 3) Analyze different types of intellectual property rights in general and protection of products derived from biotechnology research and issues related to application and obtaining patents. 4) To have knowledge about specific hazards associated with handling and manipulating human or animal cells and tissues, as well as toxic, corrosive or mutagenic 3 solvents and reagent.
MODE OF DELIVERY
Face to face
PRE-REQUISITES OF THE COURSE
No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT
No
COURSE DEFINITION
This course will provide an understanding on biosafety and risk assessment of products, ethical issues in biological research.
COURSE CONTENTS
WEEK
TOPICS
1st Week
Laboratory safety/microorganisms
2nd Week
Laboratory safety/plants-mammalian cell culture
3rd Week
General principles for the laboratory and environmental biosafety; Health aspects; toxicology, allergenicity, antibiotic resistance, etc;
4th Week
Biosafety and risk assessment issues
5th Week
Regulatory framework; National biosafety policies and law, cross border movement of germplasm; Risk management issues - containment.
6th Week
Impact on environment: gene flow in natural and artificial ecologies; Sources of gene escape, tolerance of target organisms, creation of superweeds/superviruses, etc.
7th Week
Ecological aspects of GMOs and impact on biodiversity; Monitoring strategies and methods for detecting transgenics; Transgenics to human health, society and the environment.
8th Week
Paper presentation
9th Week
The WTO and other international agreements; Intellectual properties, copyrights, trademarks, trade secrets, patents, geographical indications, etc;
10th Week
Protection of plant variety and farmers right act; Indian patent act and amendments, patent filing;
11th Week
Convention on biological diversity; Implications of intellectual property rights on the commercialization of biotechnology products
12th Week
Paper presentation
13th Week
Paper presentation
14th Week
Paper presentation
RECOMENDED OR REQUIRED READING
1.Bioethics and biosafety in Biotechnology Sree Krishna New Age Publishers 2.Sasson A, Biotechnologies and Development, UNESCO Publications, 1988. 3. Sasson A. Biotechnologies in developing countries present and future,UNESCO publishers
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS
Lecture,Discussion,Questions/Answers,Presentation
ASSESSMENT METHODS AND CRITERIA
Quantity
Percentage(%)
Presentation of Article
2
50
Other
1
50
Total(%)
100
Contribution of In-term Studies to Overall Grade(%)
100
Contribution of Final Examination to Overall Grade(%)
0
Total(%)
100
ECTS WORKLOAD
Activities
Number
Hours
Workload
Midterm exam
Preparation for Quiz
Individual or group work
1
2
2
Preparation for Final exam
1
95
95
Course hours
14
3
42
Preparation for Midterm exam
Laboratory (including preparation)
Final exam
1
3
3
Homework
Article Presentation
2
80
160
Total Workload
302
Total Workload / 30
10,06
ECTS Credits of the Course
10
LANGUAGE OF INSTRUCTION
English
WORK PLACEMENT(S)
No
KEY LEARNING OUTCOMES (KLO) / MATRIX OF LEARNING OUTCOMES (LO)
