Key Tips for Diagnostics in 2018 and Beyond: Development Success in the Evolving US and EU Landscape

“Health Decisions is offering this webinar to assist diagnostics developers in preparing to meet evolving challenges as the FDA revises and accelerates some review processes affecting diagnostics, and the EU prepares to implement new Device Directives that impose more burdensome requirements,” stated Health Decisions CEO Patrick Phillips, BSc (Hons), D.Phil. “It is critical that diagnostics companies understand the changing landscape for diagnostics development in order to plan and implement successful programs and avoid potential missteps and delays.”

Gail E. Radcliffe, PhD, President of Radcliffe Consulting and a member of the Health Decisions Scientific Advisory Board, will draw on recent experiences representing sponsors with the FDA to address topics, including:

• FDA changes to the 510(k) de novo process
• The 510(k)/CLIA Waiver dual submission
• Processes for development of companion diagnostics

Dr. Radcliffe will also discuss adjusting to the new norm of substantially faster FDA response in a variety of areas. In addition, Dr. Radcliffe will analyze the effects of new EU regulations, including more extensive review by Notified Bodies. The European Medical Device Regulations and In Vitro Diagnostic Regulations came into effect on May 26, 2017 and Notified Bodies may be authorized to perform reviews by June 2018. Dr. Radcliffe will discuss the implications of EU changes for developer decisions about whether to seek CE Mark before FDA approval, or the reverse. Dr. Radcliffe will discuss pros and cons of different development pathways for the US and EU markets. In addition, Dr. Radcliffe will address questions about the implications for diagnostics developers of regulatory changes on both sides of the Atlantic.

Health Decisions Project Manager Jessica Kappes, MBA, MT, will advise sponsors on progressing diagnostics programs from early development to subject-based testing. The transition to subject-based testing sometimes presents unexpected challenges, especially for start-up companies with in-house scientific expertise but limited experience in clinical studies. Ms. Kappes, with training as both a medical technologist and a business manager, is a highly experienced project manager for diagnostics studies involving clinical settings.

Ms. Kappes will address topics including how to determine that your product is indeed ready for trials involving collection of samples from subjects in clinical settings, and coordination of internal and external development teams to initiate clinical studies. Her goal is to help diagnostics developers assess development status to justify proceeding with confidence into large subject-based trials to support a PMA, 510(k) or dual 510(k)/CLIA waiver submission.

Above all, she wants diagnostics developers to avoid the shock of discovering after investing in a large subject-based IVD study that the investigational diagnostic is not functioning in a clinical setting as it did in the hands of diagnostics professionals in the lab.

To learn more information about this complimentary event visit: Key Tips for Diagnostics in 2018 and Beyond: Development Success in the Evolving US and EU Landscape

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