Canadian Society for Pharmaceutical Sciences
Société canadienne des sciences pharmaceutiques


Real World Data/Evidence

Use of Real World Data / Evidence to Inform Regulatory Decision Making
Tuesday, December 3, 2019
Banting Auditorium, Sir Frederick Banting Building, 251 Sir Frederick Banting Driveway, Ottawa, ON

For scientific and regulatory experts to discuss the use of data generated from routine clinical practice outside controlled clinical trials for regulatory decision making.

Who Should Attend: scientists, epidemiologists, clinical scientists, regulatory policy scientists, statisticians, regulators, public health scientists and clinicians – Advance registration now closed.  Late registrants may go directly to the workshop location to register:

Sponsorship opportunities available.

Workshop sessions will include:  

  • Regulatory Frameworks for Real World Evidence
  • Data Sources and Data Quality
  • Can RWE Replace Traditional Clinical Trials in Regulatory Decision Making?
  • Demonstrating How Real World Data/Evidence Can Be Used in the Support of Regulatory Approvals

Draft Workshop Program (session times may change)

08:00Registration
08:25Welcome
Dr. Fakhreddin (Mo) Jamali, University of Alberta

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 – 09:30Health Canada’s Efforts to Optimize the Use of Real World Evidence for Regulatory Decision Making
Dr. Gayatri Jayaraman, Health Canada 

FDA’s Real World Evidence Program
Dr. John Concato, Food and Drug Administration

Real World Evidence: European Medicines Agency experience
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 – 10:50Canadian Network for Observational Drug Effect Studies (CNODES): Data Quality Assurance Practices
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 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 – 13:00Evaluating 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
Dr. Joseph Ross, Yale University School of Medicine

Randomized Trials and Observational Studies: What’s in a Name?
Dr. John Concato, Food and Drug Administration

Should We Replace or Enhance? Modernizing Clinical Trial Designs Using Real-World Data
Dr. Elodie Baumfeld Andre, Pfizer Inc.

An Industry Perspective on Real-World Evidence in Regulatory Decision Making: An Example of Transparency in Pharmacoepidemiologic Research
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 – 16:00Demonstrating 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
Dr. Nicole Mahoney, Flatiron Health

Reimaging the Economics of Real-World Data Curation to Enable a Learning Health Care System
Aaron Liebtag, Pentavere Research Group Inc.

From Real-World Data to Real-World Patients: The O2 Program
Dr. Safiya Karim, Tom Baker Cancer Centre

16:00 – 16:30Panel Discussion – Session Chairs
16:30Closing Remarks
Dr. Celia Lourenco,  Director General, Health Canada


Workshop Registration Fees (lunch & breaks included).

CategoryEarly bird (to Nov. 15)After Nov. 15Onsite registration
CSPS Members
(Membership will be verified)
$500$700$900
Non-CSPS members$650$850$1,050
Trainees (students/postdocs)$250$450$650
Academic/Government Employees$300$500$700
Health Canada Employees$0$0$0

Email: csps@intertaskconferences.com
Tel: 613-238-4870