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Institute of Population Health
R. Samuel McLaughlin Centre for Population Health Risk Assessment

PAHO/WHO COLLABORATING CENTRE IN POPULATION
HEALTH RISK ASSESSMENT

Workshop on New Directions in Postmarket Surveillance of Pharmaceuticals & other Health Products: Improving Patient & Product Safety

University of Ottawa, Fauteux Hall, 57 Louis Pasteur St.
 Room 147
May 28-29, 2009

The workshop explored available data mining methods in pharmacovigilance and a few case studies where pharmacovigilance has helped to identify safety issues of particular drugs. It also looked at new initiatives at Health Canada for health products vigilance including pharmaceuticals, biological drugs, natural health products, and medical devices.
*A workshop summary and report will be posted at a later time.

View Agenda

 

Day 1 - Thursday, May 28, 2009

2:00pm
Welcome and Opening Remarks
Nicholas Birkett, University of Ottawa

2:10pm
An Introduction to the Statistical Methods for Signal Detectionin Pharmacovigilance
Chris Gravel, Carleton University

 

2:45pm
Signal detection in Pharmacoviglance: Comparative Performance of Several Statistical Approaches and a James-Stein Type Shrinkage Estimation Strategy in a Logistic regression Model
Lihua An, Statistics Canada & McLaughlin Centre for Population Health Risk Assessment

 

3:30pm
Cardiovascular risks associated with anti-diabetic drugs, pioglitazone and rosiglitazone
Lorraine Lipscombe, Women’s College Hospital, Institute for Clinical Evaluative Sciences & University of Toronto

 

4:05pm
Prescription drugs in pregnancy
Shi Wu Wen, University of Ottawa and Ottawa Health Research Institute (OHRI)

 

4:40pm
Summary and agenda day 2
Nicholas Birkett, University of Ottawa

 

Day 2 -  Friday May 29, 2009

9:00 am
Welcome and Opening Remarks – Day 2
Nicholas Birkett, University of Ottawa

9:10 am
Modernization of Legislation and Regulations: How does it support Product Vigilance?
Maurica Maher,Office of Legislation and Regulatory Modernizaiton, Health Products and Food Branch, Health Canada

 

9:40 am
Overview of the Health Product Vigilance Transformation Initiative
Annic Grondin, Health Products and Food Branch, Marketed Health Products Directorate, Health Canada

 

10:20 am
Canada Vigilance – Adverse Reaction Monitoring Program and Database
Heather Sutcliffe, Marketed Health Products Safety and Effectiveness Information Bureau, Marketed Health Products Directorate, Health Canada

10:50 am
Canadian Medical Devices Sentinel Network
Lynda Laforest, Marketed Health Products Directorate, Health Canada

 

11:20am
Drug Safety and Effectiveness Network (DSEN)
Dianes Forbes, Drug Safety and Effectiveness Network, Canadian Institutes of Health Research

 

1:10 pm
FDA’s Sentinel Initiative – A National Strategy for Monitoring Medical Product Safety
Judith A. Racoosin, Office of Critical Path Programs, Office of the Commissioner, FDA

  • View Slides

 

1:40 pm
Towards Comprehensive Risk Management Planning: Health Canada’s Proposed Approach
Nashwa Irfan, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Health Canada

2:20 pm
Period Safety Update Report (PSUR) Review Project
Vicky Hogan, Office of Risk Management and Science, Health Products and Food Branch, Marketed Health Products Directorate, Health Canada

 

2:50 pm
Reducing the Risk of Harm due to Medication Incidents – An Integral Component of Health Canada’s Product Vigilance Framework
Margaret Zimmerman, Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate, Health Canada

 

3:20 pm
Question Period and Discussion
Vicky Hogan, Office of Risk Management and Science, Health Products and Food Branch, Marketed Health Products Directorate, Health Canada

 

3:50 pm
Future Directions in Pharmacovigilance
Daniel Krewski, McLaughlin Centre for Population Health Risk Assessment, University of Ottawa

 

Online presentations from the Workshop on New Directions in Postmarket Surveillance of Pharmaceuticals & other Health Products: Improving Patient & Product Safety are subject to copyright protection. Permission from the speaker is required prior to any copying, reproducing, or rebroadcasting any portion of the presentations.

Other relevant documents and links for Post-Market Drug Safety and Effectiveness

 

 

Workshop support:
MITACS - Mathematics of Information Technology and Complex Systems. Canadian research network.

The workshop was organized by the McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa in collaboration with the Marketed Health Products Directorate at Health Canada.