Jamie Wolszon is speaking at the Semi-Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference

Establishing Clarity in a Sea of Gray: Complaint RUO (Research Use Only) Labeling


October 14, 2015

October 14-15, 2015 | Alexandria, VA


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point of the conference program will be overcoming regulatory hurdles in China and Europe as well as FDA insight on draft guidance regarding the acceptance of medical device clinical data from studies conducted outside the US.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 will include 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 consisting 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 will provide 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 will foster a sense of peer-to-peer collaboration.

This conference has been pre-approved by