ICH M10 Unlocked: Delivering High‑Quality, Compliant and Inspection‑Ready Bioanalytical Method Validation and Study Sample Analysis (11147)

The ICH M10 Guideline “Bioanalytical Method Validation and Study Sample Analysis” establishes globally harmonized expectations for validating bioanalytical methods and analyzing study samples supporting nonclinical and clinical drug development. 

By integrating regulatory expectations from FDA, EMA, PMDA and other authorities into one internationally accepted standard, ICH M10 has become a key reference for bioanalytical laboratories, sponsors, CROs and quality units involved in pharmacokinetic (PK), toxicokinetic (TK) and bioequivalence (BE) studies since its adoption in May 2022. 

ICH M10 defines detailed requirements for bioanalytical method validation and study sample analysis supporting regulatory submissions. Its implementation significantly impacts both chromatographic methods for small molecules and ligand binding assays for biologics and large molecules. 

The guideline outlines expectations for:   

• Full, partial and cross validation 
• Chromatographic and ligand binding assay methods 
• Calibration curves and analytical runs 
• Accuracy and precision 
• Selectivity and specificity 
• Matrix effects, dilution integrity and carry‑over 
• Stability and robustness testing 
• Reanalysis and reinjection criteria 
• Incurred Sample Reanalysis (ISR) 
• Documentation and reporting requirements 

This intensive 3‑hour live webinar provides a structured and practical overview of ICH M10 and its application in regulated bioanalytical laboratories. Emphasis is placed on interpreting the guideline, understanding common inspection findings and implementing compliant, inspection‑ready practices in daily laboratory work. While both chromatographic and ligand binding assay methods are covered, the focus remains on scientific and regulatory interpretation rather than technical instrument optimization. 

The webinar is ideal for both newcomers to bioanalytical method validation and experienced scientists, managers and QA professionals seeking to deepen or refresh their understanding of current global regulatory expectations. 

Target audience 

• Scientists and laboratory personnel in bioanalytical laboratories 
• Professionals involved in Pharmacokinetic (PK), Toxicokinetic (TK) and Bioequivalence (BE) studies 
• CRO staff working in Regulated bioanalysis 
• QA and QC personnel supporting bioanalytical activities 
• Regulatory affairs professionals preparing bioanalytical submissions 
• Study directors, project managers and laboratory managers 
• Other professionals who wish to learn more about assay development and validation in Industry 

WEBINAR AGENDA
(Thursday, 27/08/2026 | 09:00 – 12:15 CET) 

Session 1: Regulatory Framework and General Principles (09:00 – 09:45) 

• Background and objectives of ICH M10 
• Scope and applicability 
• Relationship to FDA and EMA guidance 
• GLP and GCP expectations 
• Method development principles 
• Full, partial and cross validation 
• Documentation and lifecycle considerations 

Session 2: Validation of Chromatographic and Ligand Binding Assays (09:45 – 10:45) 

• Reference standards 
• Calibration curve and range 
• Accuracy and precision 
• Selectivity and specificity 
• Matrix effects, dilution integrity and recovery 
• Dilution linearity and hook effect 
• Stability and robustness 
• Carry‑over 
• Reinjection reproducibility 
• Key differences between LC‑MS/MS and LBA validation 

Coffee Break (10:45 – 11:00) 

Session 3: Study Sample Analysis and Compliance Expectations (11:00 – 12:15) 

• Analytical run acceptance criteria 
• QC samples and calibration standards 
• Types of reanalysis 
• Incurred Sample Reanalysis (ISR) 
• Handling deviations and OOS situations 
• Data integrity and inspection readiness 
• Endogenous analytes 
• Commercial and diagnostic kits 
• Common inspection and audit findings 
• Practical recommendations for compliant implementation 

We reserve the right to adjust the programme in response to regulatory updates, time constraints or current developments. Participants will be informed accordingly. 

Duration: approx. 180 minutes
Presentation language: English
Speaker:  Dr. Akanksha Goyal

Note on contingent call-off: When booking this webinar described here, two units will be deducted per participant.

Especially for groups - Your benefits at a glance

• Attractive special prices or discounts for entire teams or small groups.
• On request, we offer customised inhouse-packages that are perfectly tailored to the needs of your department or company.
• Book Streaming+ option: Take advantage of our flexible Streaming+ format, which also allows you to have an interactive live Q&A session with the speaker to clarify your questions directly with the expert.

Feel free to contact us by email at info(at)alphatopics.de or by phone - we look forward to your enquiry.