Author: [AUTHOR] Published on 5/10/2024 5:00:00 AM
FDA’s SBIA to Host Regulatory Education for Industry (REdI) Annual Conference 2024
On May 29-30, 2024, the FDA Center for Drug Evaluation and Research (CDER)’s Small Business and Industry Assistance (SBIA) will host a two-day hybrid workshop entitled Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development. The keynote speaker will be Robert M. Califf M.D., MACC, Commissioner of Food and Drugs, and the plenary will feature the center directors from CDER, CDRH and CBER. This event offers three parallel tracks with dedicated content on drugs, devices, and biologics, and all tracks will offer an end-of-day opportunity for one-on-one questions for onsite attendees.
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
Dates/Times:
May 29-30, 2024
8:30 AM – 4:30 PM ET
Additional Details:
This is a hybrid event with in-person attendance, and continuing education credits are available. The conference is free, but registration is required. For more information on this conference, including specific topics to be covered, agenda, and intended audience, please visit the meeting website.
CDER’s SBIA aims to help small pharmaceutical business and industry navigate the wealth of information that FDA offers and assist in understanding human drug product regulation. To learn more about CDER’s SBIA, visit their website.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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