Towards Good Simulation Practices in Health Technologies - Workshop

--- IMPORTANT COMMUNICATION: PLEASE NOTE THAT DUE TO COVID-19 PUBLIC HEALTH EMERGENCY THE EVENT HAS BEEN POST-PONED TO A DATE TO BE DEFINED ---

The Food and Drug Administration (FDA) will host a public workshop entitled “Towards Good Simulation Practices in Health Technologies.”  The purpose of this public workshop is to discuss modeling and simulation practices currently used in health technologies by industry and to develop a framework for evaluating and assessing the utility of computational modeling and simulation in health technologies. The key topics to be discussed are the role of computational modeling and simulation in the regulatory evaluation of health technologies and current simulation practices, with the goal of gathering input to inform the development of good simulation practice recommendations.

When & Where

This meeting will be held April 13-15, 2020, Day 1 is from 1:00 p.m. – 5:00 p.m. and Days 2 and 3 are from 8:30 a.m. to 5:30 p.m. (EST) at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Please visit the following website for FDA Campus Information, (e.g., local airports, directions, local hotels, etc.)
https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus

The public meeting will be webcasted live and the link will be provided in your confirmation email if you registered to view the webcast.

Backgroud

Traditionally, bench testing, in vivo pre-clinical studies, and clinical trials have been the main sources of evidence generated prior to marketing medical devices in the U.S.  In recent years, however, computational modeling has become an increasingly powerful tool for evaluating medical devices, complementing bench, in vivo and clinical methods (Ref. 1).  Moreover, computational modeling methods (software) are being used more within software platforms, sometimes intended as software as a medical device  (SaMD).  Computational modeling has been identified as a priority by CDRH and FDA because of its reach and potential for driving innovation.  The Office of Science and Engineering Laboratories of CDRH has committed significant resources to transform computational modeling from a valuable scientific tool to a valuable regulatory tool and to develop mechanisms to rely more on digital evidence.  To achieve this objective, FDA Staff and Industry need a framework, or good simulation practices (like good clinical practices), to support the evaluation and utility of computational modeling and simulation in health technologies. 

CDRH is organizing a two-and-a-half-day public workshop in collaboration with industry representatives including presentations, panel discussions, poster and training sessions geared towards informing the development of good simulation practices .  

Registration

To register and see full information on the event please visit the official website