- June 6 – 10, 2022
8:30 a.m. to 4:50 p.m. ET
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With three medical product center tracks:
Drugs, devices and biologicals
Learn directly from FDA regulatory experts at Medical Product Centers: Drugs, Devices, and Biologics. This course is designed to provide participants with a solid and basic foundation of FDA regulatory requirements, and also to create awareness of ongoing activities.
Robert M. Califf MD, MACC
Food and Drug Commissioner
Patrizia Cavazzoni MD
Center for Drug Evaluation and Research (CDER)
Douglas Throckmorton, MD
Deputy Director of the Regulatory Programs Center
Center for Drug Evaluation and Research (CDER)
Jeff Shuren MD, JD
Center for Devices and Radiological Health (CDRH)
Peter Marks MD, Ph.D.
Center for Biologics Evaluation and Research (CBER)
As we now enter the 3rd year of the FDA’s public health response to the COVID-19 pandemic, this plenary session will reflect on some of the FDA’s milestones and accomplishments. We will examine the use of the Emergency Use Authorization Authority (EUA) which has advanced the timely availability of a wide range of medical products such as vaccines, drugs, diagnostics and personal protective equipment.
Along with the respective FDA Center Directors of CDER, CBER, and CDRH, we will also review future FDA activities in the fight against COVID-19 and beyond.
An Emergency Use Authorization, or EUA, is a regulatory pathway that allows the FDA to help strengthen the nation’s public health protections by facilitating the availability and use of necessary medical countermeasures during public health emergencies. Under this pathway, the FDA may authorize the use of unapproved medical products or unapproved uses of approved medical products in emergencies 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 drug route will focus on several key elements of the PDUFA VII objectives. It will identify new processes and improvements to existing practices in the human drug review program, including new approaches to increase efficiency and expand communication and feedback. Subject matter experts will provide cutting-edge insights and perspectives on how these goals will be implemented at a practical level.
- Advancing Therapies for Rare Diseases
- Improving and Modernizing the FDA Drug Safety System
- Data and Technology Driven Commitments in PDUFA VII: Updates in eCTD Areas, Study of Technical Data Rejection Criteria, CDER NextGen Portal and ESG.
- Regulatory affairs and other professionals working in the development and preparation of new drug submissions, drug safety and informatics
- Sponsors, Applicant Holders, Manufacturers, and Regulatory Affairs Professionals who want insight into the drug approval process
- Industry professionals at all levels of expertise
The track devices will provide an introduction to the device regulatory framework and useful information on developing a high-quality marketing submission. It will also discuss major program updates throughout the entire product life cycle to keep the public up to date with important device regulatory policies.
- Premarket Device Submissions, including Premarket Notification (or 510(k)
- Medical Device Inspections and Related Manufacturing Responsibilities
- Key Aspects of Regulatory Responsibilities for Post-Market Devices
- Regulatory affairs professionals looking to prepare for future device marketing applications
- Manufacturers responsible for maintaining quality systems and preparing for inspections
- Clinical researchers involved in the design and execution of high quality clinical studies and investigational device exemptions (IDEs)
The organic products track will focus on the development of advanced therapies, including cell and tissue products, gene therapies and xenotransplantation products. Speakers will present updates on various regulatory aspects of cell and gene therapy product development as well as new topics related to xenotransplantation product regulation and post-marketing safety signal assessment and mitigation. risks for approved advanced therapies.
- Updates on advanced therapies, including recently published guidelines
- Safety Monitoring and Risk Mitigation with Advanced Therapies in the Post-Approval Period
- Procedural updates on nomination submissions and meeting requests.
- Manufacturers of biotechnology products, academic sponsors and other stakeholders working to develop advanced therapies
- Regulatory Affairs and other professionals working with IND and BLA submissions in the Office of Tissues and Advanced Therapies at the Center for Biologics Evaluation and Research
- Industry and consulting professionals working with advanced therapies, cell or tissue-based products and devices used with biologics