FREE FDA CDER SBIA Workshop | Learn about Complex Products and Innovative Science in Generic Drugs| Registration Now Open | Sep. 29-30, 2020

Innov-Generics-2020-Agenda.pdf

Note: The annual FREE FDA CDER SBIA Complex Generic Drug Product Development Workshop has been renamed to: Advancing Innovative Science in Generic Drug Development Workshop September 29 & 30, 2020 | Webcast This workshop is FREE.

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Keynote Stephen M. Hahn, M.D. Commissioner of Food And Drugs U.S. Food and Drug Administration

Our annual REdI: Complex Generic Drug Product Development Workshop has been renamed in 2020 to the “REdI: Advancing Innovative Science in Generic Drug Development Workshop.” As in previous years, the SBIA conference will advance the same concepts to help the generic industry pave a clear scientific pathway for generic drug development.

We will focus on common scientific issues seen in Abbreviated New Drug Applications (ANDAs), commonly known as generic drug applications. We will link GDUFA science and research on complex products and complex scientific issues to product-specific guidance development, discuss pre-ANDA meetings and assessment, and examine various areas of the science behind generic drug development.

FEATURED TOPICS Method Development / Validations for Non-traditional Analytical Methods - Complex Active Pharmaceutical Ingredients Including Peptide Products - Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions - Development and Validation Considerations for Drug Release and Permeation Testing of Complex  Dosage Forms Excipient and Formulation Considerations Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches - Nasal and Inhalation Products - Topical Dermatologic Products - Emerging Use of Modeling and Simulation for Bioequivalence Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs Oral Products In Vitro Feeding Tube Testing and GI Locally-Acting Products

CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course: has been pre-approved by RAPS as eligible for up to 12 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.