Regulatory Education for Industry (REdI) Annual Conference 2023 - Slides and Recordings

Early this month, FDA conducted 'Regulatory Education for Industry (REdl) Annual Conference 2023'. This annual conference provided opportunity for health care industry professionals to Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. The course from annual conference is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

• The flyer about this conference: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2023-06052023
• The agenda for the conference: https://sbiaevents.com/files2023/REdI-2023-Agenda.pdf

All the FDA presentation can be watched on Youtube and the presentation slides are listed in the tables. 

There are two presentations by FDA statisticians: Dr Andrew Potter on "Reviewer’s Perspective on Data Collected by Wearable Digital Health Technology in Clinical Trials" and Dr John Scott on "FDA’s Implementation of the Estimand Framework and Complex Innovative Trial Design Meeting Program".

Plenary + Drugs Day 1:

User Fee Impact on FDA Programs Jeff Shuren, Patrizia Cavazzoni, Peter Marks

Biosimilar Program Updates and What’s New Under BsUFA III Stacey Ricci and Kimberly Maxfield

FDA Formal Meetings: What’s New under PDUFA, BsUFA, and OMUFA Elizabeth Thompson

Electronic Submission Gateway (ESG): The Road to Modernization Jessica Bernhardt

ECTD v4.0 Implementation Update Jonathan Resnick

eCTD: More than a Document Heather Crandall

CDER-CBER Data Standards Program Ray Wang

Reviewer’s Perspective on Data Collected by Wearable Digital Health Technology in Clinical Trials Andrew Potter

PDUFA VII Goals For Digital Health Technologies – A Technical Perspective Marry Ann Slack

Drugs Day 2: 

Leveraging Small Business and Industry Assistance (SBIA) Resources Renu Lal

Overview of FDA Split Real Time Application Review (STAR) Pilot Program LaShawn Schnupp

Use-Related Risk Analysis (URRA) and Human Factors (HF) Protocol Reviews: What to Submit for an Efficient Review Lolita Sterrett

The Modernization of Clinical Trials through Digital Health Technologies (DHTs), Decentralized Clinical Trials (DCTs), and Point of Care Trials Elizabeth Kunkoski

PDUFA VII Real-World Evidence Kimberly A. Smith

New PDUFA VII Commitments: Pre-approval & Post-approval Postmarketing Requirements (PMRs) Kathleen Weil

How CDER is Accelerating Rare Disease Cures and the PDUFA VII Rare Disease Endpoints Advancement Pilot Program Kerry Jo Lee

Chemistry, Manufacturing, and Controls Assessment for Expedited Programs Paresma Patel

Best Practices for Drug Product Recalls Doris Chin

Devices Day 1:

Medical Device Regulatory Framework: Where to Start? Kendra Holter

Biocompatibility Basics Jennifer Goode

Streamlining Conformity Assessment: Putting Standards to Work Scott A. Colburn

Detangling the 510(k) Process Andrew Sprau

CDRH Portal Overview and Feature Walkthrough Nelson Anderson

Reduced Medical Device User Fees: Small Business Determination (SBD) Program Jason Brookbank

Managing Medical Device Nonconforming Product with Quality Ruth Bediakoh

Handling Medical Device Compliant Files with Quality Tonya Wilbon

Devices Day 2/Biologics Day 1:

Addressing Regulatory Science Gaps in Artificial Intelligence (AI) / Machine Learning (ML) Alexej Gossmann

Radiation-Emitting Medical Device Update Laurel Burk

CDRH Medical Device Import Overview Yvette Montes

All about the Form FDA 483 and the ORA Electronic Reading Room William Chang

PDUFA VII Enhancements - Interaction with OTP Mara Miller

Overview of PREA, PSPs plus an Introduction to the Rare Pediatric Disease (RPD) Priority Review Voucher Program Adrienne Hornatko-Munoz

Nonclinical Development for Cellular and Gene Therapy Products from the Perspective of CBER/FDA Ernesto F. Moreira

Nonclinical Considerations for the Development of Cell and Gene Therapy Products for IND Submissions Gregory Conway

Clinical Readiness for IND Submissions Shelby Elenburg

Design Considerations for Clinical Trials in Rare Diseases

Rosa Sherafat

 

Biologics Day 2:

CMC Development and Readiness Pilot (CDRP) Program Ramjay S. Vatsan

CMC Considerations for Tissue Engineered Product Development Wen (Arron) J. Seeto

Identifying and Controlling Attributes Related to Potency for Cell and Gene Therapy Products Matthew Klinker

FDA’s Implementation of the Estimand Framework and Complex Innovative Trial Design Meeting Program John Scott

Postmarketing Safety and Pharmacovigilance for Vaccines Meghna Alimchandani

Expanded Access to Investigational Drugs for Treatment Use Lei Xu

CBER Inspections of Facilities for Biological Products Wei Wang