- June 6 - 10, 2022
- 8:30 AM - 4:50 PM ET
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.
Robert M. Califf M.D., MACC
Commissioner of Food and Drugs
Patrizia Cavazzoni M.D.
Center for Drug Evaluation and Research (CDER)
Douglas Throckmorton, M.D.
Deputy Center Director for Regulatory Programs
Center for Drug Evaluation and Research (CDER)
Jeff Shuren M.D., J.D.
Center for Devices and Radiological Health (CDRH)
Peter Marks M.D., PhD.
Center for Biologics Evaluation and Research (CBER)
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
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.
- 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.
- 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
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.
- Device Premarket Submissions, including Premarket Notification (or 510(k)
- Medical Device Inspections and Related Manufacturing Responsibilities
- Key aspects of the postmarket device regulatory responsibilities
- 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)
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.
- 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.
- 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 Video: What is an EUA?
- COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders
- PDUFA VII Commitment Letter
- CDER Offices and Divisions | FDA
- CDER SBIA Learn: Webinars, Conferences, Trainings
- 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
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
This course has been:
- pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area
- pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
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