• US FDA:

  Global Alliance Toward Data Integrity
  Dr. Seongeun (Julia) Cho, Director, US FDA - invited

• Italy AIFA / EU EMA:

  New GCP R3, Challenges and Opportunities: Oversight of Clinical Trials and Potential Impact on Bioanalysis
  Dr. Fabrizio Galliccia, Head of GCP Inspectorate and GCP Senior Inspector, Italy AIFA / EU EMA

• US FDA:

  OSIS Inspectional Observations 
  Dr. Arindam Dasgupta, Deputy Director, US FDA - invited

• Health Canada:

  Case Studies from Health Canada Reviews: Bioanalysis of Small Molecule Drugs
  Dr. Dany Ivanova, Senior Scientific Evaluator, Health Canada

• US FDA:

  Considerations for Bioanalysis of Liposomal Drugs in BE Studies in ANDAs
  Dr. Yang Lu, Senior Staff Fellow, US FDA

• UK MHRA:

  Regulatory Update & Specific Case Studies from Recent Inspections 
  Ms. Emma Whale, Senior GCP & GLP Inspector, UK MHRA

• US FDA:

  Analyte Instability Challenges for Bioequivalence (BE) Studies in Generic Drug Applications
  Dr. Li Yang, Pharmacologist, US FDA

• Brazil ANVISA:

  Recent Challenges in Pharmacokinetic (PK) Comparative Trials for Large Molecules
  Mr. Joao Tavares Neto , Regulatory Specialist, Brazil ANVISA

• Health Canada:

  Critical Considerations in Bioanalytical Data Review
  Dr. Helen Renaud, Scientific Evaluator, Health Canada

• UK MHRA:

  Focus on Data Integrity
  Ms. Anne-Marie Massip, GLP and GCP Inspector, UK MHRA

ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Regulated Bioanalysis / BMV

• Regulatory Panelists on Regulated Bioanalysis / BMV
  • Dr. Seongeun (Julia) Cho (US FDA - invited)
  • Dr. Arindam Dasgupta (US FDA - invited)
  • Dr. Yang Lu (US FDA)
  • Dr. Li Yang (US FDA)
  • Dr. Yow-Ming Wang (US FDA - invited)
  • Dr. Xiulian Du (US FDA)
  • Ms. Emma Whale (UK MHRA)
  • Ms. Anne-Marie Massip (UK MHRA)
  • Dr. Fabrizio Galliccia (Italy AIFA / EU EMA)
  • Dr. Anna Edmison (Health Canada)
  • Dr. Dany Ivanova (Health Canada)
  • Dr. Helen Renaud (Health Canada)
  • Mr. Joao Tavares Neto (Brazil ANVISA)

• US FDA:

  Case Studies of Pharmacodynamic (PD) Biomarker Assay Validation – Fit-for-Purpose Considerations
  Dr. Xiulian Du, Senior Science Advisor, US FDA

• UK MHRA:

  Routes to Market for Medical Devices and IVDs
  Ms. Nadine Neale, Diagnostic Regulatory Specialist, UK MHRA

• US FDA:

  An Update on Biomarker Qualification Program
  Mr. Abbas Bandukwala, Science Policy Analyst, US FDA - invited

• Belgium FAGG / EU EMA:

  Navigating Regulatory Guidance on Biomarkers and Biomarker Assays
  Dr. Olga Kholmanskikh, Clinical assessor, Belgium FAGG / EU EMA

• US FDA:

  Moving Your Validated Assay: Why you may need a U-haul
  Ms. Leslie Wagner, Consumer Safety Officer, US FDA - invited

ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Biomarkers, IVD/CDx and BAV

• Regulatory Panelists on Biomarkers, IVD/CDx and BAV
  • Mr. Abbas Bandukwala (US FDA - invited)
  • Dr. Xiulian Du (US FDA)
  • Dr. Yifei Zhang (US FDA - invited)
  • Ms. Leslie Wagner (US FDA - invited)
  • Dr. Surender Khurana (US FDA - invited)
  • Dr. Joshua Xu (US FDA)
  • Dr. Shirley Hopper (UK MHRA)
  • Ms. Nadine Neale (UK MHRA)
  • Dr. Anna Nowocin (UK MHRA)
  • Dr. Olga Kholmanskikh (Belgium FAGG / EU EMA)
  • Dr. Alessandra Buoninfante (EU EMA)
  • Dr. Chad Irwin (Health Canada)
  • Dr. Huixin Lu (Health Canada)