| | Feel free to share this announcement with colleagues.  | | FDA | Small Business and Industry Assistance CONFERENCES | | Regulatory Education for Industry (REdI) Annual Conference NEXT WEEK: July 19-23, 2021 | | | Join us and learn directly from the FDA's senior leadership and regulatory experts. This is the FIRST year that our conference includes three medical product tracks: Drugs, Devices, and Biologics   Keynote Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration | | | Plenary Session 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. | |  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., Ph.D.
Director
Center for Biologics Evaluation and Research (CBER) | | Drugs Track Topics Include: - CDER NextGen Portal
- Electronic Common Technical Document (eCTD)
- Communication Best Practices - Interacting with Regulatory Project Managers in the
Office of Regulatory Operations - Drug Development and Precision Medicine
- Role of the Product Jurisdiction Team in the Medical Product Development Process
| | Drugs Track Overview 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. | | CONTINUING EDUCATION 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: - is approved for 30.25 units of continuing education for pharmacists, physicians and nurses. Please see detailed announcement for more information.
- 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.
- has been 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.
- has been 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.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
| | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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