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, who are planning to enter the EU market, and who look to perform clinical trials in environments that offer flexibility and cost efficiency.

PROGRAM OUTLINE

• 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.

Breakfast and lunch will be served (included in registration fee).