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          Regulatory Education for Industry (REdI) Annual Conference 2023 - 06/05/2023News & Events for Human Drugs Virtual
    Event Title
              Regulatory Education for Industry (REdI) Annual Conference 2023


                  June 5 - 9, 2023

  

    
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      Meeting InformationDate:
          
  


     
                                                       
       

June 5 - 9, 2023   

 
 
        
                                      Time: 
                                      
8:40 AM
    - 4:30 PM
ET

 







Topics & Presentations Day 1
			SpeakersREdI Annual Conference 2023 – Day 1 – FDA Welcome and KeynoteFDA Welcome and Keynote Speaker
			**Robert M. Califf, MD**
			Commissioner of Food and Drugs
			Food and Drug AdministrationPlenary: User Fee Impact on FDA Programs.pdf
			**Jeff Shuren, MD, JD***Director*
			Center for Devices and Radiological Health (CDRH)

			**Patrizia Cavazzoni, MD***Director*
			Center for Drug Evaluation and Research (CDER)

			**Peter Marks, MD, PhD***Director*
			Center for Biologics Evaluation and Research (CBER)REdI Annual Conference 2023 – Day 1 – Session 2Biosimilar Program Updates and What’s New Under BsUFA III.pdf
			**Stacey Ricci, M.Eng, ScD,***Director of Scientific Review Staff (SRS)*
			Office of Therapeutic Biologics and Biosimilars (OTBB)
			Office of New Drugs (OND) | CDER

			**Kimberly Maxfield, PhD***BsUFA Regulatory Science Program Coordinator*
			OTBB | OND | CDERFDA Formal Meetings: What's New Under PDUFA, BsUFA, and OMUFA.pdf
			**Elizabeth Thompson, MS***Chief Project Management Staff*
			Division of Regulatory Operations for Nonprescription Drugs (DRO-NPD) Office of Regulatory Operations (ORO)
			OND | CDERQuestion and Answer Panel
			**Stacey Ricci, Kimberly Maxfield, and Elizabeth Thompson**REdI Annual Conference 2023 – Day 1 – Session 3ESG (Electronic Submissions Gateway)...The Road to Modernization.pdf
			**Jessica Bernhardt, MS***AdminApps Program Manager, ESG Program Manager*
			Office of Information Management & Technology (OIMT)
			Office of Digital Transformation (ODT)
			Office of the Commissioner (OC)eCTD v4.0 and Latest on eCTD.pdf
			**Jonathan Resnick***Project Management Officer*
			Division of Data Management Services and Solutions (DDMSS) Office of Business Informatics (OBI)
			Office of Strategic Programs (OSP) | CDERElectronic Submission Practicalities and Application Tips.pdf
			**Heather Crandall***Operations Research Analyst*
			DDMSS | OBI | OSP | CDERQuestion and Answer Panel
			**Jessica Bernhardt, Jonathan Resnick, and Heather Crandall**REdI Annual Conference 2023 – Day 1 – Session 4Data Standards.pdf
			**Hao (Ray) Wang***Director*
			Data Standards Staff (DSS)
			Office of Strategic Program (OSP) | CDERPDUFA VI Goals for Digital Health Technologies - A Regulatory Review Perspective.pdf
			**Andrew Potter***Mathematical Statistician*
			Division of Biometrics I (DBI)
			Office of Biostatistics (OB)
			Office of Translational Sciences (OTS) | CDERPDUFA VII Goals for Digital Health Technologies (DHT) - An IT Perspective.pdf
			**Mary Ann Slack***Director*
			OSP | CDERQuestion and Answer Panel
			**Hao (Ray) Wang, Andrew Potter, and Mary Ann Slack**



Topics & Presentations Day 2
			SpeakersREdI Annual Conference 2023 – Day 2 – Session 1Leveraging SBIA's Resources.pdf
			**Renu Lal, PharmD, BCACP***Lieutenant Commander*
			United States Public Health Service (USPHS)*Team Lead*, Division of Drug Information (DDI)
			Deputy Director, SBIA
			OCOMM | CDEROverview of FDA Split Real Time Application Review (STAR) Pilot Program.pdf
			**LaShawn Schnupp, PharmD***Senior Regulatory Health Project Manager*
			STAR Program Manager
			Program Development, Implementation, and Management Staff (PDIMS)
			Office of Program Operations (OPO) | OND | CDER

			**J. Paul Phillips, MS***Director*
			OPO | OND | CDERUse-Related Risk Analysis (URRA) and Human Factor (HF) Protocol Reviews: What to Submit for an Efficient Review.pdf
			**Lolita Sterrett, PharmD***Associate Director for Human Factors*
			Division of Medication Error Prevention and Analysis 2 (DMEPA 2) Office of Medication Error Prevention and Risk Management
			(OMEPRM)
			Office of Surveillance and Epidemiology (OSE) CDERQuestion and Answer Panel
			**LaShawn Schnupp, J. Paul Phillips, and Lolita Sterrett**REdI Annual Conference 2023 – Day 2 – Session 2The Modernization of Clinical Trials through Digital Health Technologies (DHT), Decentralized Clinical Trials (DCT) and Point of Care Trials.pdf
			**Beth Kunkoski***Health Science Policy Analyst*
			Clinical Methodologies
			Office of Medical Policy (OMP) | CDERPDUFA VII Real-World Evidence.pdf
			**Kimberly Smith***CAPT*, USPHS
			Real-World Evidence (RWE) Analytics OMP | CDERQuestion and Answer Panel
			**Beth Kunkoski and Kimberly Smith**REdI Annual Conference 2023 – Day 2 – Session 3PDUFA VII PMR (Postmarketing Requirements) Commitments: Preapproval & Postapproval.pdf
			**Kathleen (Kathy) Weil***Senior Science Policy Analyst
			PMR/PMC Program Manager*
			Safety Policy Research and Initiatives Team (SPiRIT)
			Immediate Office | OND | CDERHow CDER is Accelerating Rare Disease Cures and the PDUFA VII Rare Disease Endpoint Advancement Pilot Program.pdf
			**Kerry Jo Lee, MD***Associate Director for Rare Diseases*
			Rare Diseases Team
			Division of Rare Diseases and Medical Genetics (DRDMG)
			Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORDPURM)
			OND | CDERPDUFA VII Chemistry, Manufacturing, and Controls (CMC) Assessment Updates.pdf
			**Paresma Patel, PhD
			Director**, Division of New Drug API (DNDAPI)
			Office of New Drug Products (ONDP)
			Office of Pharmaceutical Quality (OPQ) | CDERQuestion and Answer Panel
			**Kathleen (Kathy) Weil, Kerry Jo Lee and Paresma Patel**REdI Annual Conference 2023 – Day 2 – Session 4 and ClosingBest Practices for Human Drug Product Recalls.pdf
			**Doris Chin***Consumer Safety Officer*
			Incidents, Recalls and Shortages Branch
			Division of Supply Chain Integrity
			Office of Drug Security, Integrity, and Response (OSDIR)
			Office of Compliance (OC) | CDERA Rough Guide to Biologics Manufacturing.pdf
			**Joel Welch, PhD***Associate Director for Science & Biosimilar Strategy*
			Chair for Emerging Technology Team
			Office of Biotechnology Products (OBP)
			OPQ | CDER

			**Chris Downey, PhD***Director*, Division of Biotech Manufacturing
			Office of Pharmaceutical Manufacturing Assessment (OPMA)
			OPQ | CDERQuestion and Answer Panel
			**Doris Chin, Joel Welch, and Chris Downey**Day Two Closing
			**Brenda Stodart, PharmD, BCGP, RAC-US***Captain*, United States Public Health Service*Director*, Small Business, and Industry Assistance (SBIA)
			Division of Drug Information (DDI) | Office of Communications (OCOMM) | CDER

Visit CDER Small Business and Industry Assistance Page

June 7 Recording: Devices Track

June 8 Recording: Devices and Biologics Track

June 9 Recording: Biologics Track

Device Track Slides

Biologics Track Slides



Drugs, Devices, and Biologics

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.



Photo of Dr. Robert Califf


**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., PhD.***Director*
Center for Biologics Evaluation and Research (CBER)




***NO COST Conference***

Agenda

PLENARY

Federal law authorizes the FDA to collect user fees which help the FDA fulfill its mission of promoting and protecting the public health. Most major user fee programs run in five-year cycles, and the past year saw the launch of the current cycle for CDER, CBER, and CDRH. This session will take a closer look at the impact of user fee legislation, how the FDA advances programs through user fees support, and highlights of some of the exciting new efforts planned during this user fee cycle.

DRUGS TRACK

The **drugs track** will continue its focus on PDUFA VII commitments. Subject matter experts will provide cutting edge insights and perspectives on how several of these goals and initiatives are being implemented. Agenda topics will provide practical information and advances in bioinformatics (eCTD v4.0; ESG; data standards); digital health technologies, real-world evidence (RWE) & pilot programs.

Topics Include

New Meeting Types, including What's New Under PDUFA, BsUFA, and OMUFA
	PDUFA VII Chemistry, Manufacturing, and Controls (CMC) Assessment Updates
	Use-Related Risk Analysis (URRA) and Human Factor (HF) Protocol Reviews: What to Submit for an Efficient ReviewIntended Audience

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 expertiseDEVICES TRACK

The **devices track** will provide an overview and highlights of how to get a new medical device to market. It will also discuss some best practices for ensuring that medical devices maintain their quality and continue to be safe and effective once on the market; and offer technical topic updates on biocompatibility, artificial intelligence, and radiological health.

Topics Include

Artificial Intelligence and Machine Learning; FDA Medical Device Inspections & Form FDA 483
	Premarket Notification [510(k)] Program; Quality System Principles
	Tips and Best Practices for High Quality Regulatory SubmissionsIntended Audience

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 handling complaints about their medical devices.BIOLOGICS TRACK

The **biologics track** will focus on the developmental and regulatory topics relevant to advanced therapies, including cellular and gene therapies, tissue-engineered and other biological products. The speakers will present updates on programmatic enhancements mandated by PDUFA-VII, including new regulatory programs, stakeholder communications and much more.

Topics Include

IND readiness: contents of preclinical and clinical parts; Expanded Access INDs
	Product development challenges and Chemistry, Manufacturing, and Controls (CMC) Developmental Readiness Pilot program
	Estimand and Complex Innovative Design (CID) Program in application to CBER biologicsIntended Audience

Biotechnology product manufacturers, academic sponsors, and other stakeholders working on the development of advanced therapies
	Regulatory affairs and other professionals working with submissions of INDs and BLAs to the Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research
	Industry and consulting professionals working with advanced therapies, cell- or tissue-based products, and devices used with biological productsFDA RESOURCES

Plenary

Milestones in U.S. Food and Drug Law
	FDA User Fee Programs
	FDA: User Fees ExplainedDrugs

CDER SBIA Learn: Webinars, Conferences, Trainings
	Search for Regulatory References | Drugs
	CDER Offices and Divisions | FDADevices

Medical Device User Fees
	CDRH Learn
	FDA’s Division of Industry and Consumer Education (DICE)Biologics

Interactions with Office of Therapeutic Products (formerly Office of Tissues and Advanced Therapies
	OTP Learn
	Biologics Procedures (SOPPs)

                                                                                  Content current as of:
      08/10/2023
         
                   
Regulated Product(s)
		 DrugsMore Meetings,
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