Health Decisions is offering a complimentary webinar December 14, 2017 to assist diagnostics developers in addressing regulatory changes on both sides of the Atlantic and key operational issues such as the transition to subject-based testing. Changes at FDA include faster turnaround times for some diagnostics reviews. In the EU, new Device Directives will require developers to provide more extensive evidence to obtain CE Mark, in some cases changing considerations about whether to seek approval for a novel diagnostic in the US or EU first. The webinar will also address an enduring operational challenge that trips up some diagnostics developers, especially start-up companies – managing a successful transition from early development in internal labs to subject-based studies involving clinical settings. Diagnostics developers are invited to register for the complimentary webinar which will be hosted by Xtalks.
Summary of Topics at the Diagnostics Webinar
Webinar speakers Gail Radcliffe, Ph.D., President of Radcliffe Consulting Inc. and a member of the Health Decisions Scientific Advisory Board, and Jessica Kappes, MBA, MT, CCRA, Health Decisions Project Manager, will 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
- Adjusting to the new norm of substantially faster FDA response in a variety of areas
- The effects of new EU regulations, including requirements for more extensive review of novel diagnostics by Notified Bodies
- The implications of EU changes for developer decisions about whether to seek CE Mark before FDA approval, or the reverse.
- How to determine that your product is indeed ready for trials involving collection of samples from subjects in clinical settings
- Coordination of internal and external development teams to initiate clinical studies
- The importance of conducting pilot studies in clinical settings with intended operators
Health Decisions’ domain experts look forward to a lively Q&A session with diagnostics developers following speaker presentations.