Access available presentations, abstracts and bios by clicking on appropriate link below.
| 8:00 | Registration |
| 8:25 – 08:30 | WELCOME: Dr. Co Pham, Health Canada |
| Opening Remarks: Kendal Weber, Associate Assistant Deputy Minister, Health Canada | |
| SESSION 1: Regulatory Frameworks for Real World Evidence Chair: Dr. Catherine Lau, Janssen Inc. | |
| 08:30 – 09:30 | Health Canada’s Efforts to Optimize the Use of Real World Evidence for Regulatory Decision Making (abstract) Dr. Gayatri Jayaraman, Health Canada FDA’s Real World Evidence Program (abstract) Dr. John Concato, Food and Drug Administration Real World Evidence: European Medicines Agency experience (abstract) Dr. Peter Arlett, European Medicines Agency via webex |
| 09:30 – 09:50 | Session 1 Panel Discussion |
SESSION 2: Data Sources and Data Quality – Meeting the Bar for “Fit for Purpose” in Regulatory Decision Making | |
| 09:50 – 10:50 | Canadian Network for Observational Drug Effect Studies (CNODES): Data Quality Assurance Practices (abstract) Dr. Robert Platt, McGill University Medical Product Safety Surveillance: Data Quality in the Sentinel Initiative Dr. Judith C. Maro, Harvard Pilgrim Health Care Institute Generating Fit for Purpose and Transparent Real World Evidence (RWE) to Support Regulatory Decisions Dr. Robert Reynolds, GlaxoSmithKline |
| 10:50 – 11:10 | Break |
| 11:10 – 11:30 | Session 2 Panel Discussion |
| SESSION 3: Can RWE Replace Traditional Clinical Trials in Regulatory Decision Making? What Methodologies are Needed, and in What Context Can RWE be Used? Chair: Dr. Patrick Ryan, Janssen R & D | |
| 11:30 – 13:00 | Evaluating When Real World Evidence is Reliable Enough for Regulatory Decision Making Dr. Patrick Ryan, Janssen R & D Promise and Pitfalls of Replacing Traditional Clinical Trials for Regulatory Decision Making (abstract) Dr. Joseph Ross, Yale University School of Medicine Randomized Trials and Observational Studies: What’s in a Name? (abstract) Dr. John Concato, Food and Drug Administration Should We Replace or Enhance? Modernizing Clinical Trial Designs Using Real-World Data (abstract) Dr. Elodie Baumfeld Andre, Pfizer Inc. An Industry Perspective on Real-World Evidence in Regulatory Decision Making: An Example of Transparency in Pharmacoepidemiologic Research (abstract) Dr. James Weaver, Janssen R & D |
| 13:00 – 14:00 | Lunch |
| 14:10 – 14:25 | Session 3 Panel Discussion |
SESSION 4: Demonstrating How Real World Data/Evidence Can Be Used in the Support of Regulatory Approvals | |
| 14:25 – 16:00 | Demonstrating and Communicating Real World Data (RWD) Reliability to Support Fitness-for-Use for Regulatory Decision-Making Dr. Nirosha Mahendraratnam Lederer, Duke-Margolis Center for Health Policy What’s Next? Pathways to Unlock the Value of RWD from Oncology EHRs (abstract) Dr. Nicole Mahoney, Flatiron Health Reimagining the Economics of Real-World Data Curation to Enable a Learning Health Care System (abstract) Aaron Liebtag, Pentavere Research Group Inc. From Real-World Data to Real-World Patients: The O2 Program (abstract) Dr. Safiya Karim, Tom Baker Cancer Centre |
| 16:00 – 16:30 | Panel Discussion – with Session Chairs Closing Remarks: Dr. Celia Lourenco, Director General, Health Canada |