PPT-FDA Regulatory Framework for

Devices 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. US . vs. EU. Nariko Koto, MBA. Global Regulatory/Business Consultants, LLC. January 13, 2014. For French Chamber of Commerce. Nariko Koto Bio. 15 years experience in the medical device, biologics and pharmaceutical industries. 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. Joan Wilmarth Blair. Sr. Advisor, International Affairs. Center for Biologics Evaluation and Research, FDA. Goal of Presentation. Provide an appreciation of the complex history of the Identification of Medical Product (IDMP) standards while noting the ongoing engagement of FDA, EMA and several EU MS’s. 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. Harmonization and . African Medicines Agency. Margareth Ndomondo-Sigonda. NEPAD . Planning and Coordinating Agency. Midrand, Johannesburg. South Africa. OUTLINE. Introduction to NEPAD. Background and Overview of the African . Carolyn Compton, M.D., Ph.D.,. CEO and . President. Critical Path Institute . (. C-Path). IOM Workshop International Regulatory Harmonization. Washington, DC. February 13, 2013. The Global Challenge. 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:. Application Set. LEARNING OBJECTIVES. Developing . understanding of legislative and regulatory framework of Pakistan for nuclear safety and security and regulatory infrastructure. Acquaint the participants about the functions and responsibilities of PNRA. David W. Bates MD, . MSc. , Chair. 1. Committee Membership. David W. Bates, Chair. , Brigham and Women’s Hospital. Patricia Brennan. , University of Wisconsin-Madison. Geoff Clapp. , Better. Todd Cooper. 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. . SYFTET. Göteborgs universitet ska skapa en modern, lättanvänd och . effektiv webbmiljö med fokus på användarnas förväntningar.. 1. ETT UNIVERSITET – EN GEMENSAM WEBB. Innehåll som är intressant för de prioriterade målgrupperna samlas på ett ställe till exempel:. Do you have any questions Please reach out to your account executive email regfonacom or chat at wwwfonacom/chat Let us know 147I want to hear more from FONA reg148 FONA REGULATORY SOLUTIONS 150 NITRO John Scott, Ph.D.. Director, Division of Biostatistics. Office of Biostatistics and Epidemiology. Center for Biologics Evaluation and Research. FDA. Disclaimer. This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies. Early Detection Research Network. September 9, 2019. Anand Pathak, M.D., Ph.D., M.P.H.. Division of Molecular Genetics and Pathology. Molecular Genetics Branch. OHT7(OIR)/CDRH/FDA. No financial relationship to disclose..