JEAN MONNET MODULE
Comparative EU and U.S. Science, Law and Policy in the Regulation of Pharmaceuticals and Medical Technology
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"There is no future for the people of Europe other than in union."
Jean Monnet (1888-1979) is regarded as the architect and symbol of European unity and integration. Although never elected to public office, Monnet worked behind the scenes of American and European governments as a well connected pragmatic internationalist. The Jean Monnet Action is a European Commission initiative created to promote knowledge of European integration. In universities throughout the world, the goal is to give greater visibility, at both international and national levels, to scientific resources and academic activities in the field of European integration and European Union developments.
JUNE 23- July 7, 2008 THE MAIN COURSE FOR THE MODULE
COMPARATIVE EU AND U.S. SCIENCE, LAW AND POLICY IN THE REGULATION OF PHARMACEUTICALS AND MEDICAL TECHNOLOGY Room TBA, Inlow Hall (2 cr.)
Monday, June 23rd
Introduction
(9:00-9:50 am; 10:00-Noon; 12:40- 2:00 pm)
Introduction to the Course
- Prof. Eleanor D. Kinney
The European Union: An Introduction
- Prof. Frank Emmert
Overview of Pharmaceutical and Medical Device Regulation
- Prof. Eleanor D. Kinney
Wednesday, June 25th
Comparative Regulation of Research in the U.S. and EU
(9:00-10:20 am; 10:40-12:00 N; 12:40- 2:00 pm)
The Challenges of Bringing Drugs, Biologics and Devices to Market in the EU and U.S.
- Dr. Eric Meslin, IU Center for Bioethics, IUSM
- Dr. Charles Clark, IU School of Medicine
- Prof. Kenneth Crews
- Dr. Catherine Melfi, Eli Lilly and Company
- Ralph Hall, Esq., Baker & Daniels
Ethics of Human Subjects Research
- Dr. Eric Meslin, IU Center for Bioethics, IUSM
Regulation of Human Subjects Research in the U.S. & EU
- Dr. Eric Meslin, IU Center for Bioethics, IUSM
- Prof. Frank Emmert
Friday, June 27th
Comparative EU and U.S. Intellectual Property Law
(9:00-12:00 N; 12:40- 2:00 pm)
Principles of Intellectual Property Regulation in the U.S.
- Prof. Kenneth Crews
Principles of Intellectual Property Regulation in the EU
- Prof. Kenneth Crews
- Prof. Frank Emmert
Week II
Monday, June 30th
Comparative Regulation of Intellectual Property in the Biosciences
(9:00-10:20 am; 10:40-Noon; 12:40-2:00 pm)
Framework of International IP Regulation
- Prof. Kenneth Crews
IP Patent Regulation in the EU for Drugs, Biologics and Medical Devices
- T.J. Cole, Esq., Woodard, Emhardt, Moriarty, McNett & Henry LLP
Expert Panel on IP Regulation in the EU and U.S.
- T.J. Cole, Esq., Woodard, Emhardt, Moriarty, McNett & Henry LLP
- Prof. Kenneth Crews
- Prof. Frank Emmert
Wednesday, July 2nd
Comparative Regulation of Drugs and Biologics
(9:00-10:00 am; 10:20-12:00 N; 12:40- 2:00 pm)
Regulation of Drugs and Biologics in the U.S.
- Ralph Hall, Esq., Baker & Daniels
Regulation of Drugs and Biologics in the EU
- Prof. Eleanor Kinney
Key Issues in the Regulation of Drugs and Biologics
- Dr. Catherine Melfi, Eli Lilly and Company
Monday, July 7th
Comparative Regulation of Medical Devices
(9:00-10:00 am; 10:20-12:00 N; 12:40- 2:00 pm)
Regulation of Medical Devices in the US
- Ralph Hall, Esq., Baker & Daniels
Regulation of Medical Devices in the EU
- Prof. Eleanor Kinney
Key Issues in the Regulation of Medical Devices
- Danelle Miller, Esq., Roche Diagnostics
| REGISTRATION INFORMATION To register, please call Margie Welsh (317) 274-1912 or e-mail maawelsh@iupui.edu Cost: One day session: $120.00 All six sessions: $500.00 Make checks payable to: Indiana University School of Law - Indianapolis 530 West New York Street Indianapolis, IN 46202 Attn: Margie Welsh CLE Indiana Continuing Legal Education Credit: 4 hours per day (24 hours for all six days) [Pending approval] |
THE JEAN MONNET MODULE ALSO INCLUDES THE
FOLLOWING COURSES OFFERED AT INDIANA UNIVERSITY
SCHOOL OF LAW - INDIANAPOLIS:
General courses on EU Law
EU Law - Foundations (3 cr, fall)
EU Law - Doing Business in and with the Internal Market (3 cr, spring)
Moot Court in EU Law (2 cr, fall)
European Law Summer Program
Introduction to EU law (2 cr)
Human Rights Protection Under the ECHR (1 cr)
Introduction to the French Legal System (1 cr)
Introduction to the German Legal System (1cr)
Introduction to the British Legal System (1 cr)
Other relevant courses (not contractually part of the module):
Ethical and Policy Issues in International Research (3 cr)
The New Genetics: Ethical, Legal and Policy Issues (2 cr)
Research on Human and Non-Human Subjects (2 cr)
International Intellectual Property Law (2 or 3 cr)
International Business Transactions (3 cr)
Seminar in International Legal Transactions (2 cr)
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Kenneth D. Crews Samuel R. Rosen II Professor of Law Professor of Library and Information Science Director, Copyright Management Center (On leave, January 2008 - December 2008) |
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Frank Emmert John S. Grimes Professor of Law Executive Director, Center for International and Comparative Law |
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Eleanor DeArman Kinney Hall Render Professor of Law Co-director, William S. and Christine S. Hall Center for Law and Health Executive Director, Latin American Law Program |
This course is made possible by a grant from the European Commission. The IU School of Law -
Indianapolis has sole responsibility for this course and the Commission is not responsible for any use that
may be made of the information contained therein.
