Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development – 05/29/2024
- Date:
- May 29 – 30, 2024
- Day1:
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ET - Day2:
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ET
CDER Track – Topics & Presentations Day 1 |
Speakers |
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Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Keynote and Plenary |
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Keynote Address |
Robert M. Califf, MD, MACC |
Plenary |
Patrizia Cavazzoni, MD Jeff Shuren, MD, JD Peter Marks, MD, PhD |
Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 1 |
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Selective Safety Data Collection in Clinical Trials |
Mary T. Thanh Hai, MD |
Enhancing Clinical Trial Innovation |
Kevin Bugin, PhD, MS, RAC |
Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 2 |
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AI in Drug Development |
Tala Fakhouri, PhD, MPH |
ClinicalTrials.gov: Meeting Transparency and Reporting Requirements |
Laurie Muldowney, MD |
Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 3 |
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Diversity in Clinical Trials: Drug Trials Snapshot Perspective |
Aden S. Asefa, MPH |
Combination Products – Updates and Best Practices |
Kristina Lauritsen, PhD |
CDER Track – Topics & Presentations Day 2 |
Speakers |
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Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 1 |
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Leveraging Small Business and Industry Assistance (SBIA) Resources |
Renu Lal, PharmD, BCACP, RAC-Drugs |
Key Information in Informed Consent (Clinical Trials) |
Alyson Karesh, MD Suzanne R. Pattee, JD |
FDA eCTD v4 Implementation Update and CDER NextGen Portal Update |
Jonathan Resnick Seyoum Senay |
Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 2 |
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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 |
Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 3 |
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Reimagining Clinical Research: The Transformation of Trial Design & Conduct |
Dave Burrow, PharmD, JD |
Advanced Manufacturing Technologies (AMT) Designation Program |
Ranjani Prabhakara, PhD |
Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 4 |
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Innovative Approaches to Emerging Threats |
Jill P. Furman, JD |
AGENDA
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
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