⏱ Room block closes today! Receive this email as a forward? . Banner FDA | CDER | SMALL BUSINESS AND INDUSTRY ASSISTANCE CONFERENCES Innovation in Medical Product Development REGULATORY EDUCATION FOR INDUSTRY (REDI) ANNUAL CONFERENCE 2024 - BOOKMARK AND SHARE HYBRID MAY 29 – 30 | 8:30 AM - 4:30 PM ET - In-Person at The Hotel @ the University of Maryland College Park, MD Online via Adobe Connect DRUGS, DEVICES, AND BIOLOGICS TRACKS WILL OFFER AN OPPORTUNITY FOR 1:1 QUESTIONS FOR ONSITE ATTENDEES Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities. Agenda No Fee Registration Dr. KEYNOTE SPEAKER Robert M. Califf M.D., MACC Commissioner of Food and Drugs Dr. Cavazzoni Headshot Patrizia Cavazzoni M.D. Director Center for Drug Evaluation and Research (CDER) Dr. Shuren Headshot Jeff Shuren M.D., J.D. Director Center for Devices and Radiological Health (CDRH) Dr. Marks Headshot Peter Marks M.D., Ph.D Director Center for Biologics Evaluation and Research (CBER) 🔹 PLENARY Innovation of medical products, whether it be drugs, devices, or biologics, is a continual journey that advances the needs of patients today and of future generations. Innovation takes form in many spaces such as research, product design, data collection and analysis, and we’re currently bearing witness to a golden age of technology involving artificial intelligence and genomics. This session will provide a perspective of the current state at the FDA, both with current activities and what’s to come. 🔹TOPICS COVERED Drugs Track * Enhancing Clinical Trial Innovation * Artificial Intelligence (AI) in Drug Development * Reimagining Clinical Research: The Transformation of Trial Design & Conduct Devices Track * Regulatory Science Tools * Premarket Notification [510(k)] Program * Clinical Studies, including Investigational Device Exemptions Biologics Track * Regulatory submissions for cellular and gene therapy products and patient engagement * Licensure of blood establishments * Regulation of vaccine products 🔹 INTENDED AUDIENCE * Regulatory affairs and other professionals working on the development and preparation of new drug submissions, drug safety and IT * A new regulatory affairs specialist wanting to learn some basics and best practices for getting started with FDA’s regulation of medical devices. * Biotechnology product manufacturers, academic sponsors, and other stakeholders working on the development of advanced therapies 🔹 FDA RESOURCES * CDER SBIA Learn: Webinars, Conferences, Trainings * FDA’s Division of Industry and Consumer Education (DICE) * Vaccines, Blood & Biologics Read More CONTINUING EDUCATION (CE) Real-time participation is required for the certificate of attendance, which can be used in support of CEs for the following professional organizations: RAPS, SOCRA, SQA, and ACRP. Certificates are only available during the two weeks post-event. For more information, see details on our webpage.  The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. * Register for Upcoming Training * View the SBIA 2023 YouTube Playlist * * Connect on LinkedIn * Follow on X This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at [email protected] or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |    |  Help - This email was sent to [email protected] using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA GovDelivery logo