" Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders"

Understanding How Current BMV Guidelines can be Applied to New Modalities for Regulatory Submissions; Leveraging/Applying Artificial Intelligence & Machine Learning Methodologies within Regulated Bioanalysis beyond Automation/Robotics; Can SOP being Written using AI/ML? Can AI/ML Help Develop Better and Faster Bioanalytical Method? Case Studies and Current Applications/Considerations; Recent Advances in Patient Centric Sampling for Clinical Drug Development and Microsampling for Preclinical Drug Development; Updates on the Evolving Recommendations on Clinical Sample Management; Applications of New Guidelines Related to Regulated Bioanalysis: BA/BE Testing Samples and Data Integrity Guidance; Validation of Emerging Technologies/Method in Regulated Bioanalysis: Beyond ICH M10; AND LASTLY, WRIB Traditional KOL Industry/Regulators Focused and Highly Interactive Panel Discussions on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting and Recent Controversial Issues

Session 1: Current Crucial Challenges with ICH M10 Implementation and Interpretation

Session 2: Ensuring Data Integrity in Automated Biospecimen Management and ELN Migration

Session 3: FFP Validation for Automated Methods, Three Way-Cross Validation and Urine Analysis

Session 4: ICH M10 Regulatory Queries: Protein Binding, Micro/Patient-Centric Sampling and Hybrid Assays (IA-MS)

Session 5: 2024 White Paper in Bioanalysis

• 2024 White Paper on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

  Consensus & Conclusions on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders for 2024 White Paper

Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators

• Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Bioanalysis/BMV

  Regulatory Panelists:

  • Dr. Brian Folian (US FDA)
  • Dr. Julia Cho (US FDA)
  • Dr. Arindam Dasgupta (US FDA)
  • Dr. Kimberly Benson (US FDA)
  • Dr. Yang Lu (US FDA)
  • Dr. Li Yang (US FDA)
  • Dr. Jinhui Zhang (US FDA)
  • Mr. Stephen Vinter (UK MHRA)
  • Mr. Michael McGuiness (UK MHRA)
  • Ms. Emma Whale, (UK MHRA)
  • Ms. Sonja Kwadijk-de Gijsel, (Dutch IGJ / EU EMA)
  • Dr. Anna Edmison (Health Canada)
  • Dr. Dany Ivanova (Health Canada)
  • Ms. Reza Salehzadeh-Asl (Health Canada)
  • Mr. Joao Tavares Neto (Brazil ANVISA)
  • Ms. Dulcyane Neiva Mendes (Brazil ANVISA)