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7th Semi-Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference

Our Price: $495.00

Product Code: 2268

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About the Product
Includes presentation materials from the conference. Presentations slides are in PDF. format. All files are available for immediate download.

About the 7th Semi-Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference:

Gathering Industry Stakeholders to Exchange Perspectives on Overcoming Variation among FDA Reviewers, Draft Guidance on Acceptance of Clinical Data from Studies Conducted OUS, the Economic and Regulatory Considerations of Complementary Diagnostics as well as Preparing Clinical Operations for Changing EU Regulations

As innovation continues to evolve and diagnostic tests advance in their complexity, the challenge in assuring regulatory approval increases in tandem. Manufacturers face numerous hurdles in defining clinical evidence to support and secure timely regulatory approval in an increasingly competitive global marketplace. The Semi-Annual Clinical Affairs and Regulatory Approvals for Diagnostics conference will bring together regulators as well as industry though leaders who will share and discuss the challenges faced in bringing new tests to market, as well as the strategies used to navigate through an uncertain and evolving regulatory environment.

In light of rapid globalization in the IVD space, a focal point of the conference program covered regulatory hurdles in China and Europe as well as FDA insight on draft guidance regarding the acceptance of medical device clinical data from studies conducted outside the US. Other key areas of discussion included inconsistencies in working with FDA reviewers, study design that meets FDA requirements without going over budget as well as NGS assay commercialization including regulatory and validation considerations. Discussions consisted of industry leaders that have successfully navigated a companion diagnostic to market will share practical insight and lessons learned. Designed for diagnostic manufacturers and laboratories of all sizes, this three-day executive level meeting provided participants with extensive, in-depth learning and knowledge share. Through high level case study presentations, round table panel and informal exchange group discussions complemented by multiple networking opportunities, the program fostered a sense of peer-to-peer collaboration.

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