How DDI Predictions using a static approach can support FDA and EMA drug submission and labelling
This webinar, presented by Olivier Barberan, Director, Translational Medicine Solutions at Elsevier will cover tools and best practices when using a static approach to DDI predictions to support drug submission and labeling.
Topics to be covered:
• Regulatory guidance to predict DDI (FDA, EMA, DMDA)
• Types of questions asked by regulatory agencies and how to answer them
• Use, added value and limitation of mechanistic approach and PB/PK during drug development
The format of this webinar will be a 35 minute presentation followed by a Q&A session
Part of the PharmaPendium Webinar Series: Risk Assessment in Drug Development
Tuesday, March 8, 2022 · 10:30 a.m.
Eastern Time (US & Canada) (GMT -5:00)
Director, Translational Medicine Solutions , Elsevier