Description
March 3-5, 2025 | IN PERSON (Bethesda, Washington DC)
This workshop aims to enhance understanding and practical application of PBPK modelling in drug development and regulatory interactions. It covers both foundational concepts and real-world case studies, providing valuable insights for researchers in industry, academia, and regulators.
The workshop will cover:
1. A quick introduction to PBPK modelling and exploration of extrinsic (e.g., concomitant medications) and intrinsic factors (e.g., age, organ dysfunction, genetics) on drug exposures.
2. Best Practices in PBPK model development covering integration of data from various sources, context of use and model assessment. When you can use PBPK models for extrapolation and regulatory applications.
3. Real-World case studies including drug-drug interactions, supporting dosing recommendations, application of PBPK in diverse patient groups (e.g., paediatrics, elderly, organ dysfunction) and Biopharmaceutical applications.
VENUE: Embassy Suites by Hilton Washington DC Chevy Chase Pavilion, 4300 Military Road NW, Washington, District of Columbia, 20015, USA
TIME: 09:00 - 17:00 each day
CONSORTIUM MEMBER PONTS: 3 points per person
LAPTOP: Delegates are required to bring a laptop computer, and will be provided with access to the Simcyp Simulator via Amazon Workspaces for the duration of the course.
COURSE MATERIAL: will be provided electronically via LearnUpon
Objectives
Key Takeaways
- Improved understanding of PBPK modelling principles.
- Practical insights for integrating data, developing, and assessing reliable PBPK models.
- Awareness of PBPK's potential impact on regulatory decisions.
Certificate
By completing/passing this course, you will attain the certificate Bethesda 2025
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