May 29-30, 2024
The Regulatory Education for Industry (REdI) drugs track will address major advances and innovation across various aspects of the drug development spectrum. Content will provide updates and cutting-edge insight on novel artificial intelligence (AI), clinical trial designs and innovative strategies, safety data in clinical trials, combination products, electronic submissions and more. Subject matter experts will provide insight on FDA’s perspectives, adoption of regulatory guidelines, opportunities for stakeholders to engage with CDER and best practices.
Intended Audience
- Regulatory affairs and other professionals working on the development and preparation of new drug submissions, drug safety and IT
- Sponsors, applicant holders, manufacturers, clinical researchers and regulatory affairs professionals wishing to gain insight on INDs, NDAs and BLAs
- Industry professionals at all levels of expertise
Topics Covered
- Enhancing Clinical Trial Innovation
- AI in Drug Development
- Reimagining Clinical Research: The Transformation of Trial Design & Conduct
- Advanced Manufacturing Technologies (AMT) Designation Program
- Innovative Approaches to Emerging Threats
Resources
- CDER SBIA Learn: Webinars, Conferences, Trainings
- Search for Regulatory References | Drugs
- CDER Offices and Divisions | FDA
visit the FDA.gov webpage
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Day One
Plenary