Conference | Mixed

Event Title

Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

May 19 - 20, 2026

Date:: May 19 - 20, 2026
Day1:: Tue, May 19
Day2:: Wed, May 20

Agenda Speaker Biographies

Visit CDER Small Business and Industry Assistance (SBIA) Homepage

Day 1 Recordings

CDER CDRH CBER

Day 2 Recordings

CDER CDRH CBER

Plenary Speakers

Michael Davis, MD, PhD
Acting Director
Center for Drug Evaluation and Research
(CDER)

Owen Faris, PhD
Deputy Director
Center for Devices and Radiological Health
(CDRH)

Katherine Szarama, PhD
Former Acting Director
Center for Biologics Evaluation and Research
(CBER)

Drugs, Devices, and Biologics

Tracks will Offer an Opportunity for 1:1 Questions

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

Intended Audience

Drugs

Regulatory affairs and other professionals working on the development and preparation of new drug submissions, drug safety and IT
Sponsors, applicant holders, manufacturers, clinical researchers and regulatory affairs professionals wishing to gain insight on INDs, NDAs and BLAs
Industry professionals at all levels of expertise

Devices

A new regulatory affairs specialist wanting to learn some basics and best practices for getting started with FDA’s regulation of medical devices.
A researcher of a medical device seeking to learn about the valid scientific evidence requirements needed to support new medical device regulatory submissions.
An establishment seeking to understand their regulatory responsibilities for maintaining their quality system to ensure their device is stay and effective after it’s legally marketed and in commercial distribution.

Biologics

Biotechnology product manufacturers, academic sponsors, and other stakeholders working on the development of biological products
Regulatory affairs and other professionals working with submissions of INDs, IDEs, and BLAs, and PMAs to the Center for Biologics Evaluation and Research
Industry and consulting professionals working with advanced therapies, allergenics, blood and vaccine products, and devices used with biological products

Topics Covered

Advanced Drug Manufacturing in CDER
Use of AI to Advance Drug Development
FDA’s Quality Management System Regulation (QMSR)
Small Business Determination Program Updates
Use of Digital Health Technologies for Data Collection in Clinical Trials
Benefit-Risk Framework and Analytical Methods to Inform Benefit-Risk
…Many others

FDA Resources

Drugs

Devices

Biologics

Event Materials

Title	File Type/Size
Agenda \| REdI 2026	pdf (559.54 KB)
Speaker Biographies \| REdI 2026	pdf (380.20 KB)