Bioanalytics
Eric Woolf, PhD, FAAPS (he/him/his)
Associate Vice President, Scientific
Merck and Co Inc
Souderton, Pennsylvania
Faye Vazvaei-Smith, M.S.
Executive Director
Merck & Co.
West Point, Pennsylvania
Chongwoo Yu, Ph.D.
Master Clinical Pharmacology Reviewer
US Food and Drug Administration
Silver Spring, Maryland
Enaksha Wickremsinhe, PhD (he/him/his)
Bioassay Development Lead
Bill and Melinda Gates Medical Research Institute
Cambridge, Massachusetts
Eric Woolf, PhD, FAAPS (he/him/his)
Associate Vice President, Scientific
Merck and Co Inc
Souderton, Pennsylvania
Presentation Description: The ICH M10 guideline on Bioanalytical Method Validation was published in May 2022. In the year since its publication the guidance has been adopted by the majority of the ICH member countries, including the United States, the European Union, Japan, and China. As a result of the adoption of the guidance, bioanalytical laboratories have needed to alter their processes to bring them into compliance with M10. In order to facilitate guidance adoption, the ICH M10 expert working group (EWG) has released a Q&A document and is anticipated to release a training slide deck by mid-2023. This hot topic session will provide an opportunity for members of the M10 EWG to review the Q&A and training slides with members of the bioanalytical community and will serve as a forum in which bioanalytical scientists can raise questions to the scientists that contributed to the authorship of these documents.
Gap Analysis: The 2022 ICH M10 guidance is being adopted over the course of 2023. Being new, experience with application of the guidance is low. This session will give attendees an opportunity to learn about the guidance, Q&A document and training slides from members of the expert working group that authored them.
Learning Format and Audience Engagement Details: Following two short presentations, a panel discussion/Q&A session will permit attendees to interact with members of the ICH m10 Expert Working Group
Target Audience: Staff of laboratories that perform regulated bioanalysis.