SBIA | Registration Open for Advancing Generic Drug Development: Translating Science to Approval

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance CONFERENCES Advancing Generic Drug Development: Translating Science to Approval September 21-22, 2021 This conference is free. Registration        Agenda 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. The 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 the science and cutting-edge methodologies behind generic drug development.  Learning Objectives Apply various mechanisms and processes that industry can use to obtain advice from FDA to facilitate generic drug development. Comprehend new developments in science, guidance, and review experience for specific types of generic drug products.   Intended Audience Scientists, researchers and regulatory affairs professionals who work on or are interested in working on the development of generic drugs including complex generic products that are more challenging to develop.   Topics Covered COVID-19 Impact on Generic Drug Regulation and Evaluation Assessing Generic Drug Products of Oral Dosage Forms Complex Generics: Complex Injectables, Ophthalmic and Otic Products Cutting-Edge Science in Complex Generics Complex Generics: Nasal and Inhalation Products Complex Generics: Topical Products   This workshop is part of the SBIA Regulatory Education for Industry (REdI) series. 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 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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