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          Regulatory Education for Industry (REdI) Annual Conference 2022 - 06/06/2022News & Events for Human Drugs Virtual
    Event Title
              Regulatory Education for Industry (REdI) Annual Conference 2022


                  June 6 - 10, 2022

  

    
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      Meeting InformationDate:
          
  


     
                                                       
       

June 6 - 10, 2022   

 
 
        
                                      Time: 
                                      
8:30 AM
    - 4:50 PM
ET

 

  





Topics & Presentations Day One
			SpeakersRegulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 1Keynote
			**Robert M. Califf, MD***Commissioner of Food and Drugs*
			Food and Drug AdministrationPlenary: COVID19: What’s Next for FDA?
			**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)

			Panelist:**Douglas C. Throckmorton, MD***Deputy Director Regulatory Programs*
			Center for Drug Evaluation and Research (CDER)Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 2PDUFA Program Overview and Reauthorization Process Update
			**Kevin Bugin, PhD, MS, RAC***Deputy Director for Operations*
			Office of New Drugs (OND) | CDERGuidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
			**Jeannie Roule***Chief, Project Management Staff*
			Urology, Obstetrics, and Gynecology
			Division of Regulatory Operations for Rare Diseases, Pediatrics, Urologic and Reproductive
			(DRORDPURM)
			Office of Regulatory Operations (ORO)
			OND | CDERPanel Discussion – Q&A
			**Kevin Bugin, Jeannie Roule**Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 3Advances in Drug Supply Chain Security – Focus on Distribution
			**Connie Jung, RPh, PhD***Captain*, United States Public Health Service
			Senior Advisor for Policy
			Office of Drug Security, Integrity, and Response
			(ODSIR)
			Office of Compliance (OC) | CDERIT and Informatics Goals – CDER’s Perspective
			**Mary Ann Slack***Director*
			Office of Strategic Programs (OSP) | CDERElectronic Submissions Gateway (ESG) Transparency and Modernization
			**J. Lowell Marshall, PMP, FAC-COR II**
			Office of Information Management Technology
			(OIMT)
			Office of Digital Transformation (ODT)
			Office of the Commissioner (OC)Standardizing Quality Submissions and Assessments: PQ/CMC and KASA
			**Norman Schmuff***Associate Director*
			Office of Pharmaceutical Manufacturing Assessment (OPMA)
			Office of Pharmaceutical Quality (OPQ) | CDERDiscussion Panel – Q&A
			**Mary Ann Slack, J. Lowell Marshall, and Norman Schmuff**Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 4CDER NextGen Portal - An Update
			**Seyoum Senay**
			Supervisory Operations Research Division of Data Management Services and Solutions (DDMSS)
			Office of Business Informatics (OBI)
			Office of Strategic Programs (OSP) | CDEReCTD Updates
			**Jonathan Resnick***Project Management Officer*
			DDMSS | OBI | OSP | CDERStudy Data Technical Rejection Criteria Update
			**Heather Crandall**
			Cloud Collaboration Capability Team
			DDMSS | OBI | OSP | CDERPanel Discussion – Q&A
			**Seyoum Senay, Jonathan Resnick, and Heather Crandall**



Topics & Presentations Day Two
			SpeakersRegulatory Education for Industry (REdI) Annual Conference 2022 - Day 2 - Part 1FDA Oncology Center of Excellence (OCE) Innovative Programs: Real Time Oncology Review (RTOR), Assessment Aid, and Project Orbis
			**Tamy Kim, PharmD***Director for Regulatory Affairs and Policy*
			Oncology Center of Excellence (OCE) and*Supervisory Associate Director for Regulatory Affairs* Office of Oncologic Diseases (OOD)
			OND | CDERIntegrated Assessment of Marketing Applications (IAMA)
			**Rhonda M. Hearns-Stewart, MD***Associate Director for Implementation*
			Integrated Assessment of Marketing Applications
			OND Special Programs
			OND | CDERBsUFA III: Overview of Commitments
			**Keith Olin, PharmD***Commander*, United States Public Health Service*Director of Process and Knowledge Management*
			Office of Therapeutic Biologics and Biosimilars (OTBB)
			OND | CDERPanel Discussion – Q&A
			**Tamy Kim, Rhonda M. Hearns-Stewart, and Keith Olin**Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 2 - Part 2Partnering Across FDA to Advance Therapies for Rare Diseases
			**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 | CDERFDA Rare Disease Updates: Incentives and Resources
			**Sandra Retzky, DO, JD, MPH***Director*, Office of Clinical Policy and Programs
			(OCPP)
			Office of Orphan Product Development (OOPD)
			Office of the Commissioner (OC) | FDACBER’s Perspective on Working Together with Our Rare Disease Partners across FDA
			**Julienne Vaillancourt, RPh, MPH***Captain*, United States Public Health Service*Policy Advisor and Rare Disease Liaison*
			Office of the Director
			Center for Biologics Evaluation and Research (CBER)Panel Discussion – Q&A
			**Kerry Jo Lee, Sandra Retzky, and Julienne Vaillancourt**Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 2 - Part 3FDA Adverse Event Reporting System (FAERS) Reporting and Review
			**Suranjan De, MS, MBA***Deputy Director*
			Regulatory Science Staff (RSS)
			Office of Surveillance & Epidemiology (OSE)
			CDEREnhancement and Modernization of the FDA Drug Safety System: Review of Postmarket Safety

			Commitments under PDUFA VII
			**Amy Ramanadham, PharmD., MS***Lieutenant Commander*, USHPS*Acting Associate Director for Drug Safety
			Operations*
			Office of the Center Director (OCD) | CDER

			Including panelists:**Claudia Manzo, PharmD***Director*
			Office of Medication Error Prevention and Risk Management (OMEPRM)
			Office of Surveillance and Epidemiology (OSE)

			**Patricia Bright, PhD***Acting Sentinel Program Lead*
			Sentinel Core Team | OSERisk Evaluation and Mitigation Strategies (REMS) Integration and Innovation
			**George Neyarapally, PharmD, JD, MPH, RPh***Regulatory Science Research Policy Lead*
			Regulatory Science & Applied Research Team
			OSE | CDER

			**Edward D. Millikan, PharmD, RPh***Senior Clinical Informatics Pharmacist*
			Division of Mitigation Assessment and Medication Error Surveillance (DMAMES)
			Office of Medication Error Prevention and Risk Management (OMEPRM)
			Office of Surveillance and Epidemiology (OSE)
			CDERRegulatory Education for Industry (REdI) Annual Conference 2022 - Day 2 - Part 4Leveraging SBIA's Resources
			**Renu Lal, PharmD, BCACP***Lieutenant Commander*, USPHS*Team Lead* – Division of Drug Information (DDI)
			Deputy Director, SBIA
			DDI | OCOMM | CDERPrescription Drug Labeling Updates
			**Eric Brodsky, MD***Associate Director*
			Labeling Policy Team
			Office of New Drug Policy (ONDP)
			Office of New Drugs (OND) | CDEREnhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs – An Overview of FDA’s Guidance for Industry
			**Jamie Gamerman, JD***Regulatory Counsel*
			Office of Medical Policy (OMP)
			Office of Medical Policy Initiatives (OMPI)
			CDER | FDA

June 8 Recording: Devices Track

June 9: Recording: Devices and Biologics Tracks

June 10: Recording: Biologics Track

Device Track Slides

Biologics Track Slides



Featuring three medical product center tracks:

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.

Agenda



Photo of Dr. Robert Califf


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




Photograph of Dr. Patrizia Cavazzoni
**Patrizia Cavazzoni M.D.***Director*
Center for Drug Evaluation and Research (CDER)


Photograph of Dr. Douglas Throckmorton
**Douglas Throckmorton, M.D.***Deputy Center Director for Regulatory Programs*
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)


PLENARY

As we now enter the 3rd year of FDA’s public health response to the COVID-19 pandemic, this plenary session will reflect on some of FDA’s noteworthy milestones and landmark accomplishments. We’ll review the use of the emergency use authorization (EUA) authority that advanced the timely availability of a wide range of medical products such as vaccines, drugs, diagnostics, and personal protective equipment.

Featuring the respective FDA Center Directors from CDER, CBER, and CDRH, we’ll also take a look ahead at FDA’s future activities in the fight against COVID-19 and beyond.

An emergency use authorization, or EUA, is a regulatory pathway that allows FDA to help strengthen the nation’s public health protections by facilitating the availability and use of medical countermeasures needed during public health emergencies. Under this pathway, FDA may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.

This conference is **FREE**

DRUGS TRACK

The **drugs track** will focus on several key components of the PDUFA VII goals. It will identify new processes and enhancements to existing practices of the human drug review program, including new approaches to increase efficiencies and expand communication and feedback. Subject matter experts will provide cutting edge insights and perspectives on how these goals will be implemented at the practical level.

Topics

Advancing Therapies for Rare Diseases
	Enhancement and Modernization of the FDA Drug Safety System
	Data and technology-focused commitments in PDUFA VII: updates in the areas of eCTD, study data technical rejection criteria, CDER’s NextGen portal, and ESG.Audience

Regulatory affairs and other professionals working on the development and preparation of new drug submissions, drug safety and IT
	Sponsors, applicant holders, manufacturers and regulatory affairs professionals wishing to gain insight on the drug approval process
	Industry professionals at all levels of expertiseDEVICES TRACK

The **devices track** will provide an introduction to the device regulatory framework, and useful insights into the development of a high quality marketing submission. It will also discuss key program updates across the device total product lifecycle to allow audiences to be current on important device regulatory policies.

Topics

Device Premarket Submissions, including Premarket Notification (or 510(k)
	Medical Device Inspections and Related Manufacturing Responsibilities
	Key aspects of the postmarket device regulatory responsibilitiesAudience

Regulatory affairs professionals seeking to prepare future device marketing applications
	Manufacturers responsible for maintaining quality systems and preparing for inspections
	Clinical researchers involved with the design and execution of high quality clinical studies and investigational device exemptions (IDEs)BIOLOGICS TRACK

The **biologics track** will focus on the development of advanced therapies, including cellular and tissue-based products, gene therapies, and xenotransplantation products. Speakers will present updates on various regulatory aspects of cellular and gene therapy product development along with new topics related to the regulation of xenotransplantation products and post-marketing safety signal evaluation and risk mitigation for approved advanced therapies.

Topics

Updates on advanced therapies, including recently published guidances
	Safety monitoring and risk mitigation with advanced therapies in post-approval period
	Procedural updates on application submissions and meeting requests.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 Tissues and Advanced Therapies 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

FDA Video: What is an EUA?
	COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other StakeholdersDrugs

PDUFA VII Commitment Letter
	CDER Offices and Divisions | FDA
	CDER SBIA Learn: Webinars, Conferences, TrainingsDevices

Device Advice
	CDRH Webinars
	How to Study and Market Your DeviceBiologics

OTAT Learn
	Manufacturers Assistance and Technical Training Branch website
	Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases

                                                                                  Content current as of:
      02/27/2023
         
                   
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