Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development May 29 - 30, 2024

Conference | Mixed

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• 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

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CDER Track – Topics & Presentations Day 1	Speakers
Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 - Keynote and Plenary
Keynote Address Recording	Robert M. Califf, MD, MACC  Commissioner  U.S. Food and Drug Administration (FDA)
Plenary Recording	Patrizia Cavazzoni, MD  Director  Center for Drug Evaluation and Research (CDER) Jeff Shuren, MD, JD  Director  Center for Devices and Radiological Health (CDRH) Peter Marks, MD, PhD  Director  Center for Biologics Evaluation and Research (CBER)
Regulatory Education for Industry (REdI) Annual Conference 2024: Day 1 – Session 1
Selective Safety Data Collection in Clinical Trials Recording and Slides	Mary T. Thanh Hai, MD  Deputy Director for Clinical  Office of New Drugs (OND)  CDER
Enhancing Clinical Trial Innovation Recording and Slides	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 Recording and Slides	Tala Fakhouri, PhD, MPH  Associate Director for Policy Analysis  Office of Medical Policy (OMP)  CDER
ClinicalTrials.gov: Meeting Transparency and Reporting Requirements Recording and Slides	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 Recording	Aden S. Asefa, MPH  Drug Trials Snapshot Lead  Office of Drug Evaluation Sciences (ODES)  OND | CDER
Combination Products – Updates and Best Practices Recording and Slides	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 Recording and Slides	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) Recording and Slides	Alyson Karesh, MD  Senior Clinical Advisor  OMP | CDER Suzanne R. Pattee, JD  Regulatory Counsel  Office of Clinical Policy (OCP)  Office of Clinical Policy and Programs (OCPP)  Office of the Commissioner (OC)
FDA eCTD v4 Implementation Update and CDER NextGen Portal Update Recording and Slides   CDER NextGen Portal Update Recording and Slides	Jonathan Resnick  Project Management Officer  Division of Data Management Services and Solutions (DDMSS)  Office of Business Informatics (OBI)  Office of Strategic Programs (OSP)  CDER Seyoum Senay  Supervisory Operations Research  DDMSS | OBI | OSP | CDER
Regulatory Education for Industry (REdI) Annual Conference 2024: Day 2 – Session 2
Electronic Submission Gateway (ESG) Modernization: ESG NextGen Recording and Slides	Jessica Bernhardt, MS  ESG Program Manager  Division of Application Services (DAS)  Enterprise Application Branch (EAB)  Office of Digital Transformation (ODT)  Office of Information Management and Technology (OIMT)
Q&A Discussion Panel Recording	Jessica Bernhardt and Bin Duan  ESG NextGen Lead Architect CTO  Precise Software Solutions Inc.
Artificial Intelligence (AI) | Machine Learning (ML): The New Frontier of Drug Development and Regulation Recording and Slides	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 Recording and Slides	Dave Burrow, PharmD, JD  Director  OSI | CDER
Advanced Manufacturing Technologies (AMT) Designation Program Recording and Slides	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 Recording and Slides	Jill P. Furman, JD  Director  OC | CDER

AGENDA

Visit CDER Small Business and Industry Assistance Page

Day One Recordings: 
DEVICES | BIOLOGICS

Day Two Recordings: 
DEVICES | BIOLOGICS

Device Track Slides

Biologics Track Slides

KEYNOTE SPEAKER 
Robert M. Califf M.D., MACC 
Commissioner of Food and Drugs

Patrizia Cavazzoni M.D. 
Director 
Center for Drug Evaluation and Research (CDER)

Jeff Shuren M.D., J.D. 
Director 
Center for Devices and Radiological Health (CDRH)

Peter Marks M.D., Ph.D 
Director 
Center for Biologics Evaluation and Research (CBER)

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