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Webcast | Virtual

Event Title
Regulatory Education for Industry (REdI) Annual Conference 2021
July 19 - 23, 2021


Date:
July 19 - 23, 2021

 

Presentation

Presenter

2021 REdI Conference Keynote Address

Janet Woodcock, MD
Acting Commissioner of Food and Drugs
Food and Drug Administration

Plenary Session

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

Jeff Shuren, MD, JD
Director Center for Devices and Radiological Health (CDRH)

Peter Marks, MD, PhD
Director Center for Biologics Evaluation and Research (CBER)

OND Reorganization and the New Drugs Regulatory Program Modernization

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

ANDA Efforts Related to COVID-19

John Ibrahim, PharmD
Associate Director for Regulatory Affairs (ADRA)
Office of Regulatory Operations (ORO) Office of Generic Drugs (OGD) | CDER

Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities

Alison Lyndaker
Operations Research Analyst Resource Capacity Planning Staff Office of Program and Strategic Analysis (OPSA) CDER

CDER NextGen Portal

Seyoum Senay
Supervisory Operations Research Division of Data Management Services and Solutions (DDMSS)
Office of Business Informatics (OBI) Office of Strategic Programs (OSP) | CDER

Electronic Common Technical Document (eCTD)

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

Product Quality Consideration for Emergency Use Authorizations (EUAs)

Wendy Wilson-Lee, PhD
Division Director
Division of New Drug Products II Office of New Drug Products (ONDP) Office of Pharmaceutical Quality (OPQ) | CDER

Strategies to Address Potential Medication Errors for EUA Products for COVID-19

Sevan Kolejian, PharmD, MBA, BCPPS
Team Leader Division of Medication Error Prevention and Analysis I (DMEPAI)
Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) | CDER

Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine

Qi Liu, PhD, MStat, FCP
Associate Director for Innovation & Partnership
Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) | CDER

CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development 

Andrea Gormley, PharmD
LCDR, USPHS
Associate Director for Regulatory Affairs

Kelly Ngan, PharmD
CDR, USPHS
Team Leader
Project Management and Emergency Coordination Counter-Terrorism and Emergency Coordination Staff (CTECS) Office of Center Director (OCD) | CDER

Where Do We Go from Here? How the Ombudsman Can Help

Virginia Behr
Ombudsman
Office of Executive Programs (OEP) CDER

Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO

Jacqueline Ware, PharmD CAPT, USPHS
Chief of Project Management Staff (acting)
Neurology 2 RPM Group
Division of Regulatory Operations for Neuroscience
and Deputy Director, Office of Regulatory Operations (ORO) OND | CDER

Communications in a Global Pandemic

James-Denton (JD) Wyllie
Director
Office of Communications (OCOMM) CDER

Regulatory Policy: Role in Guiding Decision Making in CDER

Stefanie Kraus, JD, MPH
Senior Regulatory Counsel
Division of Regulatory Policy II Office of Regulatory Policy (ORP) CDER

Role of the Product Jurisdiction Team in the Medical Product Development Process

Kristina Lauritsen, PhD
CDER Combination Products
 Regulatory Policy Advisor OEP | CDER

FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency

John Concato, MD, MS MPH
Associate Director of Real World Evidence Analytics (Acting)
Office of Medical Policy (OMP) | CDER

OSI’s Role in the Drug Development Process and Impact of COVID-19

Laurie Muldowney, MD
Deputy Director
Office of Scientific Investigations (OSI) Office of Compliance (OC) | CDER

July 21 Recording: Devices Track

July 22 Recording: Devices and Biologics Tracks

July 23 Recording: Biologics Track

Drugs Track Slides

Devices 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.

AGENDA

 

Janet Woodcock

KEYNOTE SPEAKER

Janet Woodcock M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration

FDA Voices Article by Dr. Woodcock

 

 

PLENARY

This plenary session will reflect on FDA’s use of Emergency Use Authorizations (EUAs) and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic.

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.

Patrizia Cavazzoni

Patrizia Cavazzoni M.D.
Director
Center for Drug Evaluation and Research (CDER)

Jeff Shuren

Jeff Shuren M.D., J.D.
Director
Center for Devices and Radiological Health (CDRH)

Peter Marks

Peter Marks M.D., PhD.
Director
Center for Biologics Evaluation and Research (CBER)

 

This conference is FREE

DRUGS TRACK

The drugs track will focus on the operations of Center for Drug Evaluation and Research (CDER) offices directly involved in the drug assessment process and their interaction with each other.

Topics

  • CDER NextGen Portal
  • Communication Best Practices
  • Drug Development and Precision Medicine

Audience

  • Regulatory affairs and other professionals working on the development and preparation of new drug submissions
  • Sponsors, applicant holders, manufacturers and regulatory affairs professionals wishing to gain insight on drug assessment
  • Industry professionals at all levels of expertise

DEVICES TRACK

The devices track will focus on evidence quality and data expectations that impact regulatory decisions involving medical devices regulated by the Center for Devices and Radiological Health (CDRH).

  • Premarket submissions
  • Quality system principles
  • Additive manufacturing

Audience

  • Industry professionals working on development and preparation of new device submissions
  • Manufacturers and regulatory affairs professionals seeking to enhance their knowledge about the FDA Quality System (21 CFR 820) and applicable subsystems
  • Device manufacturers and innovators seeking to incorporate additive manufacturing into their device processes and regulatory strategies

BIOLOGICS TRACK

The biologics track will focus on the development of advanced therapies, including cellular and tissue-based products, gene therapies, plasma-derived therapeutics, and devices regulated by Center for Biologics Evaluation and Research (CBER). Different aspects of product development will be discussed (product quality, pharmacology toxicology, and clinical).

Topics

  • “Tissue Rule”: Regulation of products under 21 CFR part 1271
  • Development and regulation of cellular therapies, gene therapies, and plasma-derived therapeutics
  • Expedited development programs for advanced therapies

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

Drugs

Devices

Biologics

 
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