Registration Reminder: FDA-CRCG Workshop on Model-Integrated Approaches to Bioequivalence for Long-Acting Injectable & Implantable Drug Products

This public workshop will focus on how model-integrated approaches support innovative study designs and data analyses for bioequivalence ass

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . Registration Reminder: FDA-CRCG Workshop on Model-Integrated Approaches to Bioequivalence for Long-Acting Injectable & Implantable Drug Products   Just a few weeks away! Join FDA and the Center for Research on Complex Generics for the Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products public workshop, November 30, 2021. This public workshop will focus on how model-integrated approaches support innovative study designs and data analyses for bioequivalence assessment and how they can be validated and verified. Collaborative development of these best practices could contribute to the availability of more long-acting injectable and implantable generic drug products for the American public.    This workshop is FREE and the agenda is now available. Register Now TOPICS Current challenges in development and assessment of generic long-acting injectables and implantable drug products Recent research on the development of model-integrated bioequivalence approaches – innovative study designs and data analysis for bioequivalence assessment Application of model-integrated approaches to long-acting injectable and implantable drug products using population pharmacokinetic modeling Validation and verification for model-integrated bioequivalence approaches Building consensus on best practices for model-integrated bioequivalence approaches   AUDIENCE Generic and new drug industries, academia, and other involved stakeholders with a particular interest in the field of modeling and simulation. This workshop is a co-sponsored event between FDA and the Center for Research on Complex Generics (CRCG).   The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow 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, 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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