Registration now open for FDA and CRCG co-hosted free virtual public workshop

Registration for the FDA and CRCG co-hosted virtual public workshop is now open for Generic and new drug industries, academia, and other involved stakeholders with a particular interest in the field of modeling and simulation.

The workshop will be held virtually through eventbrite on November 30th, 2021.

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

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

To register for the event, visit the eventbrite website.

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