Reminder - SBIA | Advancing Generic Drug Development Workshop

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Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WORKSHOP Advancing Generic Drug Development  Translating Science to Approval September 20-21, 2022 Day 1 – 8:00 a.m. – 5:10 p.m. Eastern Time Day 2 – 8:00 a.m. – 5:00 p.m. Eastern Time This event is FREE. Register Agenda Test Your Knowledge With Our LinkedIn Poll KEYNOTE SPEAKER Robert M. Califf M.D., MACC Commissioner of Food and Drugs This virtual public workshop will communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval. This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development, and pre-ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development. This workshop will also provide some insight into upcoming GDUFA III enhancements. Learning Objectives: Comprehend new developments in science, guidance, and regulatory assessment experience for generic drug products Understand FDA's perspectives, research, and regulatory assessment relating to generic drug development Apply various mechanisms and methodologies that drug developers can use to facilitate generic drug development This event is part of the SBIA Regulatory Education for Industry (REdI) series. AUDIENCE Scientists, researchers, current and prospective generic drug applicants, and regulatory affairs professionals who work on or have an interest in the development of generic drugs, including complex generic products. 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: has been pre-approved by RAPS as eligible for a maximum of 12 credits (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. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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