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Regulatory frameworks in support of emerging healthcare technologies

February 14 2011

Venue:

Seminar Room 1.06
ESRC Innogen Centre
Edinburgh University
Old Surgeons' Hall
High School Yards
Edinburgh
EH1 1LZ


Time: 3.30-5pm


All welcome, no need to book

Organised by: Innogen, University of Edinburgh

Abstract:


This talk draws on some of the research carried out in the EPSRC funded Emerging Industries Programme, which forms part of the Cambridge Institute for Manufacturing's Innovative Manufacturing Research Centre (IMRC), and which aims to explore the different drivers affecting the emergence of science-based industries.


Focussing on emerging healthcare technologies and on the ways in which their regulatory environment can play a constructive and enabling role to support them, it will present two recent regulatory initiatives as examples of supportive regulatory frameworks. The first one is the Advanced Therapy Medicinal Products Regulation, designed by the EU Commission with a view to harmonising the regulatory requirements for regenerative medicine based therapeutic products in the EU. The second one is the Innovation Unit embedded within the French Regulatory Agency for Healthcare Products and tasked with fostering medical innovations.


This talk will provide an opportunity to discuss some of the challenges regulators face when dealing with emerging healthcare technologies to accommodate scientific changes and to give companies and investors an acceptable degree of certainty and predictability in a fast moving environment. It will also highlight the necessity for regulators to engage in new and innovative approaches to regulation as they are expected to design supportive and anticipatory requirements in partnership with industry.


Speaker Biography:


Laure Brévignon-Dodin has been a Research Associate within the Centre for Industry and Government since September 2005. Her work focuses on investigating regulatory frameworks and designing regulatory options to assist in the emergence of new technologies and industries.


She has collaborated with several EPSRC programmes. She completed a project research as part of the REMEDI Grand Challenge which was concerned with understanding the conditions to support the emerging industry of regenerative medicine in the UK. She is currently exploring the regulatory environment for commercialisation of photonic and electronic based products for the Cambridge Integrated Knowledge Centre (CIKC) project. She is also involved with the Emerging Industries Programme wherein she is investigating how regulation impacts on innovation.


Prior to joining the University of Cambridge, Laure’s work experience was in politics. She worked in Paris as a government practitioner for the Minister of Health and as a representative for a parliamentary group at the French National Assembly. She also gave lectures in public law and supervised research work at the Sorbonne University for 10 years.


Her background is mostly legal with a postgraduate degree in EU law. She studied international law and politics at Trinity College, Dublin.

http://www.genomicsnetwork.ac.uk/innogen/events/pastevents/seminars/furtherdetails,24174,en.t4.html