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FDA | CDER | Small Business and Industry Assistance
CONFERENCES
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Regulatory Education for Industry (REdI) Annual Conference 2024
Innovation in Medical Product Development
Hybrid
May 29 – 30 | 8:30 AM - 4:30 PM ET
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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.
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 Patrizia Cavazzoni M.D.
Director
Center for Drug Evaluation and Research (CDER)
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 Jeff Shuren M.D., J.D.
Director
Center for Devices and Radiological Health (CDRH)
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 Peter Marks M.D., Ph.D
Director
Center for Biologics Evaluation and Research (CBER)
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🔹 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 the 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
- Enhancing Clinical Trial Innovation
- Artificial Intelligence (AI) in Drug Development
- Reimagining Clinical Research: The Transformation of Trial Design & Conduct
- Regulatory Science Tools
- Premarket Notification [510(k)] Program
- Clinical Studies, including Investigational Device Exemptions
- Regulatory submissions for cellular and gene therapy products and patient engagement
- Licensure of blood establishments
- Regulation of vaccine products
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🔹 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
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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.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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