Friday's SBIA Webinar: Regulatory Perspectives for Development of Drugs for Treatment of NASH

FDA | CDER | Small Business and Industry Assistance  WEBINARS Regulatory Perspectives for Development of Drugs for Treatment of NASH January 29, 2021 | 1:00 - 2:30 p.m. Eastern This webinar is FREE and has been approved for 1.5 continuing education units for physicians, pharmacists, and nurses. See CE announcement for more details. Register FDA will provide a summary of FDA's current thinking on the published draft guidance documents: Noncirrhotic Nonalcoholic Steatohepatitis with Liver Fibrosis: Developing Drugs for Treatment Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment TOPICS Phase 2 drug development for NASH Clinical trial inclusion/exclusion for phase 3 NASH trials Surrogate efficacy endpoints that have been acknowledged by FDA as reasonably likely to predict clinical benefit Clinical endpoints for the confirmation of clinical benefit Strategies at clinical drug development for NASH AUDIENCE Regulatory affairs professionals working on NASH drug development Pharmaceutical and academic researchers enrolling patients into NASH drug development programs Consultants focused on providing advice to sponsors involved in NASH drug development Clinical research coordinators overseeing research in NASH Healthcare professionals specializing in gastroenterology and hepatology CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance. Certificates are only available during the two weeks post-event. This course: has been pre-approved by RAPS as eligible for up to 1.5 credits 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 0.25 non-GCP or non-GLP units 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 program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance, education and regular updates for regulated industry. Register for Upcoming Training Subscribe to CDER SBIA Email Updates Watch the Learning Library on YouTube Follow SBIA on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.   SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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