Stuart McDougall: European Bioanalysis Forum Workshop Contribution
Written by Emilie Bergstrom
Stuart McDougall Contributes to ‘Conference Report from the European Bioanalysis Forum Workshop: Toward Harmonized Implementation of the ICH M10 Guideline’ in Bioanalysis Journal
Quotient Sciences’ Principal Research Fellow of Bioanalytical Services, Stuart McDougall, is a representative on the European Bioanalysis Forum (EBF), which is an organization comprising bioanalytical scientists working within the pharmaceutical industry that provides a platform for discussions on science and regulatory issues. At the latest EBF workshop in November 2022, entitled ‘Toward Harmonized Implementation of the ICH M10 Guideline’, Stuart was one of 250 delegates representing 125 different organizations who attended. The purpose of the workshop was to discuss the final International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – Multidisciplinary Guideline N◦10 (ICH M10) after its publication in May 2022. Stuart moderated several plenary and breakout sessions on different chapters of the ICH M10 guideline and contributed to the resulting conference report as a co-author.
In this report, the EBF shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop. The focus of the discussions was to understand new, changed, or still ambiguous regulatory expectations in the guideline, as identified in feedback from the pre-workshop surveys or during the workshop. The proposals from the workshop aim at stimulating and helping a harmonized implementation of the guideline and using the EBF community as a sounding board during and after implementation to highlight areas of misalignment and to create a platform for continued sharing with the regulatory authorities in an effort to contribute to industry and regulators developing similar interpretations on guideline expectations.
Stuart McDougall comments: “The ICH M10 is the culmination of many years of work by regulators and bioanalysts across the world to unify into a single global bioanalytical guideline and eliminate the regional and geographic differences. However, the publication of ICH M10 is only the first step, as we need to ensure a consistent and agreed understanding and implementation across our industry. 2023 will be a very important year, as we live with ICH M10 during our day-to-day activities.”
Bioanalytical services from Quotient Sciences
Delivering rapid bioanalytical data is critical to meeting milestones in drug development. From drug discovery to pre-clinical and clinical studies, understanding drug exposure, safety, and metabolism are essential in accelerating drugs to clinic and commercialization. At Quotient Sciences, we are experts in the development, validation, and application of bioanalytical assays.