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  1. News & Events for Human Drugs

Virtual | Virtual

Event Title
Regulatory Education for Industry (REdI) Annual Conference 2022
June 6 - 10, 2022


Date:
June 6 - 10, 2022
Time:
8:30 AM - 4:50 PM ET

 

 

Topics & Presentations Day One

Speakers

Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 1

 

Keynote

Robert M. Califf, MD
Commissioner of Food and Drugs
Food and Drug Administration

Plenary: 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 2

 

PDUFA Program Overview and Reauthorization Process Update

Kevin Bugin, PhD, MS, RAC
Deputy Director for Operations
Office of New Drugs (OND) | CDER

Guidance 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 | CDER

Panel Discussion – Q&A

Kevin Bugin, Jeannie Roule

Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 3

 

Advances 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) | CDER

IT and Informatics Goals – CDER’s Perspective

 

Mary Ann Slack
Director
Office of Strategic Programs (OSP) | CDER

Electronic 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) | CDER

Discussion Panel – Q&A

Mary Ann Slack, J. Lowell Marshall, and Norman Schmuff

Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 1 - Part 4

 

CDER 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) | CDER

eCTD Updates

Jonathan Resnick
Project Management Officer
DDMSS | OBI | OSP | CDER

Study Data Technical Rejection Criteria Update

Heather Crandall
Cloud Collaboration Capability Team
DDMSS | OBI | OSP | CDER

Panel Discussion – Q&A

Seyoum Senay, Jonathan Resnick, and Heather Crandall

 

Topics & Presentations Day Two

Speakers

Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 2 - Part 1

 

FDA 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 | CDER

Integrated Assessment of Marketing Applications (IAMA)

Rhonda M. Hearns-Stewart, MD
Associate Director for Implementation
Integrated Assessment of Marketing Applications
OND Special Programs
OND | CDER

BsUFA 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 | CDER

Panel Discussion – Q&A

Tamy Kim, Rhonda M. Hearns-Stewart, and Keith Olin

Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 2 - Part 2

 

Partnering 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 | CDER

FDA 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) | FDA

CBER’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 3

 

FDA Adverse Event Reporting System (FAERS) Reporting and Review

Suranjan De, MS, MBA
Deputy Director
Regulatory Science Staff (RSS)
Office of Surveillance & Epidemiology (OSE)
CDER

Enhancement 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 | OSE

Risk 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)
CDER

Regulatory Education for Industry (REdI) Annual Conference 2022 - Day 2 - Part 4

 

Leveraging SBIA's Resources

Renu Lal, PharmD, BCACP
Lieutenant Commander, USPHS
Team Lead – Division of Drug Information (DDI)
Deputy Director, SBIA
DDI | OCOMM | CDER

Prescription Drug Labeling Updates

Eric Brodsky, MD
Associate Director
Labeling Policy Team
Office of New Drug Policy (ONDP)
Office of New Drugs (OND) | CDER

Enhancing 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 expertise

DEVICES 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 responsibilities

Audience

  • 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 products

FDA RESOURCES

Plenary

Drugs

Devices

Biologics

 
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