BEGIN:VCALENDAR VERSION:2.0 PRODID:-//wp-events-plugin.com//7.3.6//EN TZID:America/Phoenix X-WR-TIMEZONE:America/Phoenix BEGIN:VEVENT UID:1623@azbio.org DTSTART;TZID=America/Phoenix:20210719T084000 DTEND;TZID=America/Phoenix:20210723T161000 DTSTAMP:20210708T224630Z URL:https://www.azbio.org/events/fdas-regulatory-education-for-industry-re di-annual-conference-2021 SUMMARY:FDA's Regulatory Education for Industry (REdI) Annual Conference 20 21 - - 19 Jul 21 08:40 DESCRIPTION:\nRegister today for this free conference about FDA's regulator y requirements\nJoin the FDA for the Annual 2021 Regulatory Education for Industry (REdI) Conference taking place virtually on July 19-23. It is an FDA-led forum that brings together experts across the agency to provide p articipants with a foundation of FDA’s regulatory requirements.\nThis co nference is FREE\nLearn directly from the FDA’s regulatory experts in m edical product centers: drugs\, devices\, and biologics. This course is de signed to provide participants with a strong\, basic foundation in the FDA ’s regulatory requirements. This conference has been approved for 30.25  continuing education units for pharmacists\, physicians\, and nurses. Pl ease see detailed announcement for more information.\n\n\n\n\n Date:\n \n\n\n\nJuly 19 - 23\, 2021\n\n\n\n Time:\n \n\n\n\n8:40 AM - 4:10 PM ET \n\n\n\n\n\n\n\n\n\n\n\n\nAttend\n\nRegister for This Event\n\n\n\n\nFeatu ring three medical product center tracks:\nDrugs\, Devices\, and Biologics \nLearn directly from the FDA’s regulatory experts in medical product ce nters: drugs\, devices\, and biologics. This course is designed to provide participants with a strong\, basic foundation in the FDA’s regulatory r equirements. This conference has been approved for 30.25 continuing educa tion units for pharmacists\, physicians\, and nurses. Please see detailed announcement for more information.\nAGENDA\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nKE YNOTE SPEAKER\nJanet Woodcock M.D.\nActing Commissioner of Food and Drugs\ nFood and Drug Administration\n\n\n\n\n\n\n\n\n\n\n\nPLENARY\nThis plenary session will reflect on FDA’s use of Emergency Use Authorizations (EUAs ) and other resources in making drug\, device\, and biological products av ailable to support the public health response to the COVID-19 pandemic.\nA n emergency use authorization\, or EUA\, is a regulatory pathway that allo ws FDA to help strengthen the nation’s public health protections by faci litating 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 use d in an emergency to diagnose\, treat\, or prevent serious or life-threate ning diseases or conditions when there are no adequate\, approved\, and av ailable alternatives.\n\n\n\n\n\n\n\nJeff Shuren M.D.\, J.D.\nDirector\nCe nter for Devices and Radiological Health (CDRH)\n\n\n\n\n\n\n\n\n\n\nPatri zia Cavazzoni M.D.\nDirector\nCenter for Drug Evaluation and Research (CDE R)\n\n\n\n\n\n\n\n\n\n\nPeter Marks M.D.\, PhD.\nDirector\nCenter for Biol ogics Evaluation and Research (CBER)\n\n\n\n\n\n\n\n\n\n\n\nDRUGS TRACK\nT he drugs track will focus on the operations of Center for Drug Evaluatio n and Research (CDER) offices directly involved in the drug assessment pro cess and their interaction with each other.\nTopics\n\n\n CDER NextGen Po rtal\n Communication Best Practices\n Drug Development and Precision Med icine\n\nAudience\n\n\n Regulatory affairs and other professionals workin g on the development and preparation of new drug submissions\n Sponsors\, applicant holders\, manufacturers and regulatory affairs professionals wi shing to gain insight on drug assessment\n Industry professionals at all levels of expertise\n\n\n\n\n\n\n\n\nDEVICES TRACK\nThe devices track wil l focus on evidence quality and data expectations that impact regulatory d ecisions involving medical devices regulated by the Center for Devices and Radiological Health (CDRH).\n\n\n Premarket submissions\n Quality syste m principles\n Additive manufacturing\n\nAudience\n\n\n Industry profess ionals working on development and preparation of new device submissions\n Manufacturers and regulatory affairs professionals seeking to enhance the ir knowledge about the FDA Quality System (21 CFR 820) and applicable subs ystems\n Device manufacturers and innovators seeking to incorporate addit ive manufacturing into their device processes and regulatory strategies\n\ n\n\n\n\n\n\n\nBIOLOGICS TRACK\nThe biologics track will focus on the de velopment of advanced therapies\, including cellular and tissue-based prod ucts\, gene therapies\, plasma-derived therapeutics\, and devices regulate d by Center for Biologics Evaluation and Research (CBER). Different aspect s of product development will be discussed (product quality\, pharmacology toxicology\, and clinical).\nTopics\n\n\n “Tissue Rule”: Regulation of products under 21 CFR part 1271\n Development and regulation of cellul ar therapies\, gene therapies\, and plasma-derived therapeutics\n Expedit ed development programs for advanced therapies\n\nAudience\n\n\n Biotechn ology product manufacturers\, academic sponsors\, and other stakeholders w orking on the development of advanced therapies\n Regulatory affairs and other professionals working with submissions of INDs and BLAs to the Offic e of Tissues and Advanced Therapies in the Center for Biologics Evaluation and Research\n Industry and consulting professionals working with advanc ed therapies\, cell-or tissue-based products\, and devices used with biolo gical products\n\n\n\n\n\n\n\n\nCONTINUING EDUCATION\nReal-time attendance is required for the certificate of attendance which can be used in suppor t of CEs for the following professional organizations. Certificates are on ly available during the two weeks post-event.\nThis course has been:\n\n\n approved for 30.25 continuing education units for pharmacists\, physici ans\, and nurses. Please see detailed announcement for more information.\ n pre-approved by RAPS as eligible for a maximum of 12 credits for a 2 da y event (appropriate to real-time attendance) towards a participant’s RA C recertification upon full completion.\n pre-approved by SOCRA who accep ts documentation of candidate participation in continuing education progra ms for re-certification if the program is applicable to clinical research regulations\, operations or management\, or to the candidate's clinical re search therapeutic area.\n pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participa nt’s RQAP re-registration.\n approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-6 0 minutes of qualified material.\n\n\n\n\n\n\n\n\nTECHNICAL INFORMATION AN D QUESTIONS\n\n\n To optimize your webinar experience\, use Chrome when v iewing AdobeConnect in a browser.\n Please contact info@sbiaevents.com  for all technical questions.\n If you encounter any technical issues befo re or during the event\, please visit the Technical Issues Support page. \n Test your PC for use with Adobe Connect prior to the day of the event . Adobe\, the Adobe logo\, Acrobat and Acrobat Connect are either register ed trademarks or trademarks of Adobe Systems Incorporated in the United St ates and/or other countries.\n\n\n\n\n\n\n\n\nFDA RESOURCES\nDrugs\n\n\n CDER SBIA Learn: Webinars\, Conferences\, Trainings\n CDERLearn Training and Education\n Development &\; Approval Process\n\nDevices\n\n\n Dev ice Advice: Comprehensive Regulatory Assistance\n CDRH Learn\n Division of Industry and Consumer Education\n\nBiologics\n\n\n OTAT Learn\n Manuf acturers Assistance and Technical Training Branch website\n Testing Human Cells\, Tissues\, and Cellular and Tissue Based Product (HCT/P) Donors fo r Relevant Communicable Disease Agents and Diseases\n\n\n\n\n\n\n\n\nRegis ter Now! END:VEVENT BEGIN:VTIMEZONE TZID:America/Phoenix X-LIC-LOCATION:America/Phoenix BEGIN:STANDARD DTSTART:20200719T084000 TZOFFSETFROM:-0700 TZOFFSETTO:-0700 TZNAME:MST END:STANDARD END:VTIMEZONE END:VCALENDAR