Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development – 05/29/2024

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

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