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Opportunities for US Medical Device and Biotech Companies in the Changing EU Clinical and Regulatory Environment
03/01/2016 @ 8:00 AM - 1:00 PM$50
A seminar presented by Elisabeth Liljensten, DDS, PhD, founder and CEO of Swedish CRO DEVICIA, Åsa Runnäs, CEO at Symbioteq a Swedish Regulatory Affairs Consultancy and Tomas Camnell, founder of Symbioteq
To generate clinical data and get approval with a CE-mark provide a number of opportunities for US Medical Device and BioTech companies. Currently there is a comprehensive change of the regulatory environment in the EU. The requirements are getting stricter and there is a heavy focus on clinical data that support safety and efficacy. This development has an impact on products already CE-marked and new products that are to be CE-marked. The changing regulatory landscape presents both opportunities and challenges for US Medical Device and BioTech companies. The seminar will address how to navigate this new and changing environment, and what is to be expected over the next few years.
Who should attend?
Executives of medical device and biotech companies who:
– market their products in Europe
– are planning to enter the EU market
– look to perform clinical trials in environment that offer flexibility and cost efficiency
Dr Elisabeth Liljensten is the CEO of the medical device CRO Devicia AB/Devicia Inc. She has +20 years experience of medical device clinical trials and has had several senior positions in medical device developmental companies. Dr Liljensten is a Doctor of Dental Surgery with a PhD degree in Biomaterials research.
Fredrik Hansson is VP of the medical device CRO Devicia AB. He has close to 30 years experience in statistics and data management within the life science industry in different senior positions. Fredrik holds a M.Sc. in statistics from University of Lund, Sweden.
Åsa Runnäs is part owner and CEO of Symbioteq. Åsa also works as consultant and training officer with a focus on quality assurance and regulatory compliance for the medical device industry and has had several senior QA/RA positions in medical device companies. Åsa holds a M.Sc from the Royal Institute of Technology, Sweden.
Tomas Camnell is the founder of Symbioteq and has been working in the life science industry for more than 30 years. The past 20 years as consultant at Symbioteq, with QA/RA consultation and training, in several cases also acting as QA Manager in Medical Device companies.
08.00 Continental breakfast and registration
09:00 Introductions and presentations
11:00 Panel with Elisabeth Liljensten, Åsa Runnäs and two US experts
12:00 Lunch and networking
12:45 Concluding remarks
– Different kinds of clinical trials and registries in the EU.
– How European clinical data can support US market entry.
– Handling of data and statistics.
– Ongoing changes in EU regulations. CE marking of medical devices – requirements and how to fulfill them.
– Changed requirements in ISO 13485:2016.
– Panel discussion. Q&A.