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          Regulatory Education for Industry (REdI) Annual Conference 2021 - 07/19/2021 - 07/23/2021Drugs Webcast
    Event Title
              Regulatory Education for Industry (REdI) Annual Conference 2021


                  July 19 - 23, 2021

  

    
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      Meeting InformationDate:
          
  


     
                                                       
       

July 19 - 23, 2021

 

  



Presentation
			Presenter2021 REdI Conference Keynote Address
			**Janet Woodcock, MD**
			Acting Commissioner of Food and Drugs
			Food and Drug AdministrationPlenary 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) | CDERANDA Efforts Related to COVID-19
			**John Ibrahim, PharmD**
			Associate Director for Regulatory Affairs (ADRA)
			Office of Regulatory Operations (ORO) Office of Generic Drugs (OGD) | CDERResource 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) CDERCDER 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) | CDERElectronic Common Technical Document (eCTD)
			**Jonathan Resnick**
			Project Management Officer
			DDMSS | OBI | OSP |CDERProduct 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) | CDERStrategies 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) | CDERClinical 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) | CDERCDER’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) | CDERWhere Do We Go from Here? How the Ombudsman Can Help
			**Virginia Behr**
			Ombudsman
			Office of Executive Programs (OEP) CDERCommunication 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 | CDERCommunications in a Global Pandemic
			**James-Denton (JD) Wyllie**
			Director
			Office of Communications (OCOMM) CDERRegulatory 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) CDERRole of the Product Jurisdiction Team in the Medical Product Development Process
			**Kristina Lauritsen, PhD**
			CDER Combination Products
			 Regulatory Policy Advisor OEP | CDERFDA 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) | CDEROSI’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 expertiseDEVICES 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 strategiesBIOLOGICS 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**

CDER SBIA Learn: Webinars, Conferences, Trainings
	CDERLearn Training and Education
	Development & Approval Process**Devices**

Device Advice: Comprehensive Regulatory Assistance
	CDRH Learn
	Division of Industry and Consumer Education**Biologics**

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:
      08/03/2021More Meetings,
      Conferences, and
      Workshops
        
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                        Regulatory Science Research and Education
          Development & Approval Process | Drugs
          Drug Safety and Availability
          Emergency Preparedness | Drugs
          Guidance, Compliance, & Regulatory Information
          News & Events for Human Drugs
          Resources | Drugs
          Science and Research | Drugs
 
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