Posted in | Pharmaceuticals and Drug Discovery

What’s changing in DDI guidance? A closer look at ICH M12

From Apr 10 2025

This on-demand webinar breaks down the key changes in regulatory guidance for predicting drug-drug interaction (DDI) risks, focusing on what’s new in ICH M12 compared to previous FDA and EMA guidelines.

Topics covered:

  • The current regulatory landscape for in vitro DDI assays
  • What’s new in ICH M12 and how it differs from past FDA/EMA guidance
    • Drug-metabolizing enzymes and transporters
    • The role of binding in DDI assessment
  • Study design updates and workflow considerations
  • Translating in vitro findings into clinical DDI risk predictions

About the speakers

  • Helen Rollison – Principal Scientist, in vitro DMPK at Pharmaron
  • Ying Wang – Senior Director, Regulatory in vitro ADME at Pharmaron
  • Lingling Zheng – Director, in vitro ADME at Pharmaron
  • Moderated by Chris Bode – VP of Scientific Affairs at Pharmaron

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