U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development - 05/29/2024
  1. News & Events for Human Drugs

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:
- ET
Day2:
- 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
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

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
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

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

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)

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

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

AGENDA

Visit CDER Small Business and Industry Assistance Page

Day One Recordings:
DEVICES | BIOLOGICS

Day Two Recordings:
DEVICES | BIOLOGICS

Robert M. Califf M.D., MACC photograph

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

Patrizia Cavazzoni, M.D.

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

Photograph of Dr. Jeff Shuren

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

Dr. Peter Marks photograph

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

Back to Top