Webinar Addresses Regulatory Changes in the US and EU and Operational Challenges in Subject-Based Testing
Leading Diagnostics CRO Health Decisions to Assist Developers in Preparing for Changing Diagnostics Development Landscape
Durham, North Carolina. Health Decisions, Inc., the full-service clinical research organization of choice for forward-looking diagnostics, biopharma and medical device companies, today announced a webinar for diagnostics developers to be hosted by Xtalks on Thursday, December 14, 2017. The webinar is entitled “Key Tips for Diagnostics in 2018 and Beyond: Development Success in the Evolving US and EU Landscape.” Developers are invited to register for the complimentary webinar.
“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.”
Key Tips for Diagnostics Developers on Regulatory Changes
Speakers at the webinar will be 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. Together they will address both high-level regulatory strategy and operational challenges in clinical validation studies of investigational diagnostics.
Dr. Radcliffe 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
- 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.
Key Tips on Preparing for the Transition to Subject-Based Testing
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
- Coordination of internal and external development teams to initiate clinical studies
- The importance of conducting pilot studies in clinical settings with intended operators
Ms. Kappes’ 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.
About Health Decisions
Health Decisions is a full-service CRO offering therapeutic, operational and regulatory excellence for clinical development of drugs, diagnostics, medical devices and combination drug/devices in all areas of women’s health. Based on therapeutic and operational experience and investigator relationships developed in studies conducted over the past 28 years, Health Decisions successfully addresses the challenges of developing diagnostics in all therapeutic areas and drugs and devices in areas including reproductive and sexual health, menopause, pain management, osteoporosis/osteoarthritis, reproductive psychiatry, gynecologic oncology and general gynecology indications. Health Decisions is headquartered in Durham, NC.
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Senior Marketing Specialist
+1 919.967.1111 ext. 520
lhammill @ healthdec.com
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