35106 - Policy and Legislation in Animal Biotechnology

Learning outcomes

Students learn the regulatory acts applicable to Animal Biotechnologies and their main problematic aspects. They are able to understand and use legal terminology appropriately; they know the administrative tools envisaged and the authorization and surveillance procedures applicable to the specific case; they are able to autonomously issue judgments of feasibility and legal compliance in relation to specific application cases. Finally, they know the sanctioning framework and the main bioethical fronts on which the prospects for reform of the legislative framework move.

It should be noted that this course is part of an integrated course, at the end of which the student is able to plan and undertake research in the animal biotechnology field. With the completion of all the courses provided by the C.I. the student knows the molecular basis of biological processes applied to cell cultures and animal models, as well as the rules of experimental design in compliance with the standards, and is capable of carrying out cell cultures and analyzing nucleic acids and proteins.

Course contents

1) Fundamental legal principles

2) Legal aspects concerning the GMO, and particularly:

• Contained use
• Deliberate release
• Traceability and labelling
• Medical products
• Intellectual Property
• Transport
• Environmental liability
• Cartagena Protocol on Biosafety
• Export to non-EU Member States

3) Introduction to Animal Ethics

 

The syllabus of the course is on the page:

https://corsi.unibo.it/magistrale/BiotecnologieAnimali/syllabus/35106-politica-e-legislazione-peccolo.pdf

Readings/Bibliography

G. Peccolo, Nozioni Giuridiche Fondamentali, CLEUP

 

Regulatory acts of the European Union:

- Directive 2010/63/EU

- Directive 2009/41/CE

- Directive 2001/18/CE

- Directive 98/44/CE

Teaching methods

Frontal lessons, working groups

Assessment methods

At the end of the course, an oral exam is scheduled, aimed at assessing not only the acquisition of knowledge required, but also the acquisition of the relevant skills.

Evaluation criteria:

- understanding of the student with respect to the individual topics required

- ability to exposure, link and compare different aspects and contents

- ability to apply theoretical knowledge to concrete situations

Access to the test is free. The test will take about 20 minutes. Aids are not allowed, except for those who are entitled.

A total mastery of all the topics of the course, together with an equal capacity for critical analysis, connection and a sure mastery of the specific terminology will be evaluated with the maximum score (30-30L)

A very satisfactory knowledge of the topics covered in the course, combined with a convincing analytical and critical skills, and the possession of adequate command of the specific terminology will be evaluated with very good score (27-29)

A good preparation, technically suitable for acting in the field, in line with the objectives of the course, which in any case demonstrates at least moderate analytical and connection skills, all expressed in correct language, will produce evaluations in the evaluation range 23-26.

Sufficient preparation and capacity for analysis, expressed in barely formally correct language, will determine the pass mark, 18-22.

This teaching  is part of an Integrated Course, the final grade will be proportional to the CFU of each teaching

35106  Policy and Legislation in Animal Biotechnology 3CFU 20%

66437  Applied Experimental Biology 6CFU 40%

66435  Applied Molecular Biology 6CFU 40%

 

Teaching tools

Collection of UE textson:

http://www.law.stanford.edu/program/centers/ttlf/law/eu/bi/#Intellectual_Property

Office hours

See the website of Giampaolo Peccolo