PPT-FDA Regulatory Framework for

Devices Applied to HIT Bradley Merrill Thompson Epstein Becker amp Green June 7 2013 1 Roadmap Exercise Overview Health IT Use Case Mechanical Ventilation Weaning FDA Device Regulatory Framework. Bruce Ross. , . M.A. M.P.H.. Director, India Office. Agenda. Priorities. Challenges of globalization. cGMP. . deficiencies. Comparison. Post inspection regulatory . actions. 2. Advance Regulatory Science: the science of developing new tools, standards and approaches to assess the safety and effectiveness, quality and performance of FDA-regulated products. Mark . Atalla. , . PharmD. Disclosure. I have no relevant financial relationships with commercial interests pertaining to the content presented in this program. Objectives. 3. Key Things to Walk Away With:. Devices. Bradley Merrill Thompson. Epstein Becker & . Green. June . 7, . 2013. 1. Roadmap. Exercise Overview . Health IT Use Case – Mechanical Ventilation Weaning. FDA Device Regulatory Framework. Tina Morrison, Ph.D.. Chair, Modeling and Simulation Working Group. Office of the Chief Scientist. Deputy Director, Division of Applied Mechanics. Office of Science and Engineering Laboratories. U.S. Food and Drug Administration. Regulatory Control Training Workshop. Regulatory Cooperation Forum. Peter Hughes. 6-10 November, 2017. Morocco. Learning Objectives. After going through this presentation the participants are expected to be familiar with:. (i.e. no one has seen or approved this). Draft 07/01/13. Coordination. This is the point at which we need to truly start integrating the work products of the subgroups. .. We need to look at the safety issues and assess whether they are addressed. A report of the typist for the Regulation Subgroup. (i.e. no one has approved this). Draft 07/11/13. Questions considered. Are . the three regulatory systems – ONC, FCC and FDA – deficient in any way with regard to how HIT is regulated. Investigational New Drug Application (IND); Summary of regulations and guidelines . Introduction of . cGMP's. /principles of validation . Introduction to QA/QC principles . Good Laboratory Practice (GLP) compliance . May 22, 2013. Agenda. 4:00 p.m. Call to Order. – . MacKenzie. Robertson. Office of the National Coordinator for Health Information Technology. 4:05 p.m. Opening Remarks . – . Brad Thompson and Julian Goldman, Co-Chairs. FDA Modeling and Simulation Working Group. Sponsored by the Office of the Chief . Scientist Fall 2016. Main . Objectives. :. Raise awareness of the successes, challenges and opportunities for modeling and simulation to advance regulatory science at the FDA;. precision.fda.gov | precisionFDA@fda.hhs.gov | @precisionFDA. Taha A. Kass-Hout, MD, MS. FDA Chief Health Informatics . Officer. Director, FDA’s Office of Health . Informatics. David . Litwack. , PhD. to request assistance Our Office of Information Management and Technology OIMT will work with your firm to set up secure communicationsPlease notify the investigator of any delays due to this encrypti John Michael Sauer, PhD. Critical Path Institute’s Predictive Safety Testing Consortium. Tucson, Arizona. jsauer@c-path.org. So you have a biomarker(s) that you want to use for regulatory decision making…now what do you do?. John Scott, Ph.D., FDA/CBER/OBE. Joint PSI, EFSPI & ASA BIOP Webinar: Estimands. November 5, 2020. www.fda.gov. Disclaimer. This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies..