ENRICHMENT
Overview
MDIC is an active member of the ENRICHMENT in Silico Clinical Trial Project (ENRICHMENT), which is led by principal investigators from FDA and Dassault Systèmes. In this capacity, MDIC is coordinating the formation of an Industry Advisory Council (IAC) for the project. The role of the IAC is to provide an industry perspective on new clinical trial methodology and tools being developed through ENRICHMENT including the practicality of implementing such approaches at a commercial level so as to ensure ENRICHMENT outputs are relevant to the medical device industry. More specifically, the IAC’s primary function shall be to provide guidance and input on the relevance and utility of the approaches to the regulatory process (rather than those related to technical aspects of the modeling and simulation).
Qualifications
IAC representatives should be employed by medical device companies that distribute class 2 or 3 medical devices (of any nature) directly to the market and have experience conducting (directly or indirectly) clinical trials. We are seeking two representatives per company – one “regulatory” and the other “technical”.
- Regulatory representatives should be focused on or have experience with regulatory affairs and/or quality processes.
- Technical representatives should be focused on or have an understanding of R&D (virtual and physical) processes and issues.
Regulatory and technical representatives will work together in tandem and the other IAC representatives. There is no requirement that a candidate representative’s company be a MDIC member.
Commitment
IAC members will be expected to serve for a minimum period of one year. The IAC will convene at least quarterly to receive project updates and review and discuss proposed approaches and methodologies. In addition and as the project lifecycle warrants, in between such meetings, the project principal investigators may request more immediate input from the IAC through community exchanges and/or interim meetings. Virtual attendance at meetings is acceptable.
Program Leadership
Steven Levine, PhD
Senior Director, Virtual Human Modeling - Dassault Systèmes
Join in and make an impact!
To learn more, please contact MDIC staff at CMS@mdic.org.
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