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CMIC Resources

CMIC Resources

Bioanalytical Method Validation: Challenges and Opportunities of a Globally Harmonized System (ICH M10)

ICH M10 is the first-ever global set of guidelines for bioanalytical method validation and presents new challenges for pharmaceuticals manufacturers. Navigate these uncharted waters with expert insights from a recent roundtable discussion on harmonized bioanalytical testing.

  • Understand the new ICH M10 guidelines for harmonization of bioanalytical testing
  • Recognize ICH M10’s implications for pharma and biotechnology companies
  • Navigate the challenges and opportunities stemming from ICH M10
  • Learn about how the ICH M10 guidelines may impact the pace of drug development and clinical trials moving forward

Panelists Include:

  • Jaya Gopal, PhD, Executive Vice President, Research and Preclinical Development, PepGen
  • Chandani Joshi, MS, Associate Director, Large Molecule, CMIC Group
  • Fumiyuki Nakagawa, Global Business Development, CMIC Group
  • Jenifer Vija, PhD, Bioanalytical Consultant
  • Angela Whatley, PhD, Regulatory Consultant
  • Andrew Warmington, Manufacturing Editor, Custom Content, Citeline (Moderator)

The panelists discussed the new ICH M10 guidelines for harmonization of bioanalytical testing, implications for pharma and biotechnology companies, challenges and opportunities that come from these guidelines, and what they might mean for the pace of drug development and clinical trials moving forward.

Report Overview

Over the past 13 years, regional scientific associations have collaborated to create the Global Bioanalysis Consortium and harmonize global bioanalytical guidelines. This effort recently culminated in the development of ICH M10, a set of harmonized guidelines that provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the analysis of study samples.

For drug developers, ICH M10 presents some compliance challenges related to method development, testing capabilities, and documentation—but also important opportunities.

Learn more now about the new ICH M10 guidelines and what they mean for your development program. Gain an inside view with input from a panel of industry experts.



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