Join us for a discussion during which you can get the latest news on all the regulatory developments in Europe and North America, and we'll discuss options to help you steer away from risk and uncertainty and toward a more certain path to market.

The overhaul of the European medical device regulatory framework has device makers concerned that their current and future offerings may find a more difficult path to market, but the regulatory scene has become even more complicated thanks to the U.K.'s decision to part ways with the European Union.

The European Medicines Agency is working on a concept paper dealing with companion diagnostics that are co-developed with the therapeutic drug even as the FDA continues to grapple with its own draft CDx co-development guidance. The American agency has its own list of tasks that would seem to add to the uncertainty for device makers in the U.S.

Featured Speakers:

Elizabeth Hollis
Clarivate Analytics

Elizabeth Hollis is a writer and editor who has covered the medical device, pharmaceutical, and healthcare sectors for a decade. She started at Clarivate Analytics in January 2017, focusing on FDA drug/device advisory committee meetings and drug approvals for Cortellis and the AdComm Bulletin.

Mark McCarty
Regulatory Editor
BioWorld MedTech

Mark McCarty has served as the Washington editor for BioWorld MedTech since March 2006. He covers FDA’s regulation and compliance/enforcement activities for medical devices, but also reviews Medicare coverage and reimbursement. Mark’s portfolio at BioWorld MedTech includes coverage of medical device advisory committees, congressional hearings and medical specialty society meetings. Among the subjects he covers are patent law, patent reform legislation and liability law.


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