"Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"
Current challenges in the application of BMV Guidelines to New Modalities for Regulatory Submissions; Implementation of AI/ML methodologies within Regulated Bioanalysis beyond Automation/Robotics; Enabling AI/ML in Regulated Bioanalytical Lab considerations for adoption and governance; Is NAMs impacting traditional Regulated Bioanalysis or not? NAMs applications in Preclinical Evaluation by improving human relevance while reducing dependence on traditional animal studies and Regulatory Expectations; Development of Piloted AI Reporting Tools and Case studies and current applications/considerations; ICH M10 Cross Validation: was Industry/Regulators’ harmonization reached? Recent advances in Patient Centric Sampling for Clinical Drug Development and Microsampling for Preclinical Drug Development in Regulated Bioanalysis; Updates on the evolving recommendations on Clinical Sample Management; Applications of new Guidelines related to Regulated Bioanalysis: BA/BE Data Integrity; New insights on Bioavailability and Bioequivalence Studies in support of complex generic drugs; Emerging Technologies/Methods in Regulated Bioanalysis: Beyond ICH M10. Traditional KOL Industry/Regulators focused and highly interactive panel discussions on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting and recent Controversial Issues.
Session 1: Current Best Practices for Method Transfer & Cross-Validation
Session 2: Fit-for-Purpose Bioanalytical Methods for Rare Matrix & Radiopharmaceuticals
Session 3: Enhancing Bioanalytical Performance by Capability-based Trending, CRLs Lesson Learned, Specimen Management Optimization
Session 4: Adapting BMV Strategies beyond ICH M10 for Different Matrices/RoA & Alternative Sampling
Session 5: 2027 White Paper in Bioanalysis
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2027 White Paper on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting
Consensus & Conclusions on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting for 2027 White Paper
Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
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Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Bioanalysis/BMV
Regulatory Panelists:
