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

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

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

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