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)
| 08:00 | Registration |
| 08:25 | Welcome Dr. Fakhreddin (Mo) Jamali, University of Alberta Opening Remarks |
| 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 Dr. Gayatri Jayaraman, Health Canada FDA’s Real World Evidence Program Real World Evidence: European Medicines Agency experience |
| 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 – Chair: Dr. Robert Platt, McGill University | |
| 09:50 – 10:50 | Canadian 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 Generating Fit for Purpose and Transparent RWE to Support Regulatory Decisions |
| 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 Randomized Trials and Observational Studies: What’s in a Name? Should We Replace or Enhance? Modernizing Clinical Trial Designs Using Real-World Data An Industry Perspective on Real-World Evidence in Regulatory Decision Making: An Example of Transparency in Pharmacoepidemiologic Research |
| 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 – 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 Reimaging the Economics of Real-World Data Curation to Enable a Learning Health Care System From Real-World Data to Real-World Patients: The O2 Program |
| 16:00 – 16:30 | Panel Discussion – Session Chairs |
| 16:30 | Closing Remarks Dr. Celia Lourenco, Director General, Health Canada |
Workshop Registration Fees (lunch & breaks included).
| Category | Early bird (to Nov. 15) | After Nov. 15 | Onsite 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