- July 19 - 23, 2021
8:40 AM - 4:10 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.
Janet Woodcock M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration
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.
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)
This conference is FREE
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.
- CDER NextGen Portal
- Communication Best Practices
- Drug Development and Precision Medicine
- 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
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
- 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
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).
- “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
- 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
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 2 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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- CDER SBIA Learn: Webinars, Conferences, Trainings
- CDERLearn Training and Education
- Development & Approval Process
- Device Advice: Comprehensive Regulatory Assistance
- CDRH Learn
- Division of Industry and Consumer Education
- 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