Conference | Mixed
Event Title
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development
May 29 - 30, 2024
- Date:
- May 29 - 30, 2024
- Day1:
- Wed, May 29 8:30 a.m. - 04:30 p.m. ET
- Day2:
- Thu, May 30 8:30 a.m. - 04:30 p.m. ET
| CDER Track – Topics & Presentations Day 1 | Speakers |
|---|---|
| Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 - Keynote and Plenary | |
| Keynote Address | Robert M. Califf, MD, MACC Commissioner U.S. Food and Drug Administration (FDA) |
| Plenary | Patrizia Cavazzoni, MD Jeff Shuren, MD, JD Peter Marks, MD, PhD |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 1 | |
| Selective Safety Data Collection in Clinical Trials | Mary T. Thanh Hai, MD Deputy Director for Clinical Office of New Drugs (OND) CDER |
| Enhancing Clinical Trial Innovation | Kevin Bugin, PhD, MS, RAC Deputy Director OND | CDER |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 2 | |
| AI in Drug Development | Tala Fakhouri, PhD, MPH Associate Director for Policy Analysis Office of Medical Policy (OMP) CDER |
| ClinicalTrials.gov: Meeting Transparency and Reporting Requirements | Laurie Muldowney, MD Deputy Director Office of Scientific Investigations (OSI) Office of Compliance (OC) CDER |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 3 | |
| Diversity in Clinical Trials: Drug Trials Snapshot Perspective | Aden S. Asefa, MPH Drug Trials Snapshot Lead Office of Drug Evaluation Sciences (ODES) OND | CDER |
| Combination Products – Updates and Best Practices | Kristina Lauritsen, PhD Combination Product Regulatory Advisor Product Jurisdiction and Combo Product Team Office of Executive Programs (OEP) CDER |
| CDER Track – Topics & Presentations Day 2 | Speakers |
|---|---|
| Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 1 | |
| Leveraging Small Business and Industry Assistance (SBIA) Resources | Renu Lal, PharmD, BCACP, RAC-Drugs Lieutenant Commander, US Public Health Service (USPHS) Team Lead, Division of Drug Information (DDI) Deputy Director, SBIA Office of Communications (OCOMM) CDER |
| Key Information in Informed Consent (Clinical Trials) | Alyson Karesh, MD Suzanne R. Pattee, JD |
| FDA eCTD v4 Implementation Update and CDER NextGen Portal Update CDER NextGen Portal Update | Jonathan Resnick Seyoum Senay |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 2 | |
| Electronic Submission Gateway (ESG) Modernization: ESG NextGen | Jessica Bernhardt, MS Bin Duan |
| Artificial Intelligence (AI) | Machine Learning (ML): The New Frontier of Drug Development and Regulation | Qi Liu, PhD, MStat, FCP Associate Director for Innovation & Partnership Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) CDER |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 3 | |
| Reimagining Clinical Research: The Transformation of Trial Design & Conduct | Dave Burrow, PharmD, JD Director OSI | CDER |
| Advanced Manufacturing Technologies (AMT) Designation Program | Ranjani Prabhakara, PhD Policy Lead Office of Policy for Pharmaceutical Quality (OPPQ) Office of Pharmaceutical Quality (OPQ) CDER |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 4 | |
| Innovative Approaches to Emerging Threats | Jill P. Furman, JD Director OC | CDER |
Visit CDER Small Business and Industry Assistance Page
Day One Recordings:
DEVICES | BIOLOGICS
Day Two Recordings:
DEVICES | BIOLOGICS
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.
DRUGS TRACK DEVICES TRACK BIOLOGICS TRACK