Canadian Society for Pharmaceutical Sciences
Société canadienne des sciences pharmaceutiques

RWE Presentations

Access available presentations, abstracts and bios by clicking on appropriate link below.


8:25 – 08:30WELCOME: 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 – 09:50Session 1 Panel Discussion

SESSION 2: Data Sources and Data Quality – Meeting the Bar for “Fit for Purpose” in Regulatory Decision Making 
Chair: Dr. Robert Platt, McGill University

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 – 11:10Break
11:10 – 11:30Session 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 – 14:00Lunch
14:10 – 14:25Session 3 Panel Discussion

SESSION 4: Demonstrating How Real World Data/Evidence Can Be Used in the Support of Regulatory Approvals
Chair Dr. Nirosha Mahendraratnam Lederer, Duke-Margolis Center for Health Policy

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