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Workshop on Post Market Drug Safety and Effectiveness
May 22-23, 2008
University of Ottawa
Desmarais Building,
55 Laurier East, Room 1150
The Post Market Drug Safety and Effectiveness workshop background
information and introduction are available on the Canadian Institutes
of Health Research’s (CIHR) - Institute of Health Services and
Policy Research (IHSPR).
http://www.cihr-irsc.gc.ca/e/36434.html
The workshop summary and report can be found on CIHR’s website
Workshop summary
http://www.cihr-irsc.gc.ca/e/36803.html
Final report
http://www.cihr-irsc.gc.ca/e/36890.html
Day 1 - Thursday, May 22, 2008
9:00am
Introduction and Welcome
Daniel Krewski, University of Ottawa
cphra@uottawa.ca
9:05am
Objectives – Day 1
Noralou Roos, University of Manitoba
Noralou_Roos@cpe.umanitoba.ca
9:10am
A proposed Pharmacovigilance Network for Canada
Steve Morgan, University of British Columbia
morgan@chspr.ubc.ca
9:30am
Federal Drug Regulatory Process
Cindy Evans, Health Canada
cindy_evans@hc-sc.gc.ca
9:50am
Progressive Licensing Framework
Karen Timmerman, Health Canada
karen_timmerman1@hc-sc.gc.ca
10:15am
Price Review Process for Patented Medicines
Ginette Tognet, Patented Medicine Prices Review Board (PMPRB)
gtognet@pmprb-cepmb.gc.ca
11:00am
Common Drug Review (CDR)
Mike Tierney, Canadian Agency for Drugs and Technologies
in Health (CADTH)
miket@cadth.ca
11:25am
Ontario Perspective
Brent Fraser, Ministry of Health and Long Term Care, Ontario
Public Drug Programs
brent.fraser@ontario.ca
11:50am
Federal Drug Plan Management
Perspective
Susan Pierce, First Nations & Inuit Health Branch,
Health Canada
susan_pierce@hc-sc.gc.ca
1:30pm
Dementia drugs
Neena Chappell, University of Victoria via teleconference
nlc@uvic.ca
1:50pm
Chemotherapeutic agents
Jeff Kirby, Dalhousie University
Judy McPhee, Nova Scotia Department of Health
JKirby@tupdean2.med.dal.ca
mcpheej@gov.ns.ca
2:10pm
Leveraging Data to Inform Health Decision-Makers
Muhammad Mamdani, Applied Heatlh Research Center, Keenan
Research Centre, Li Ka Shing Knowledge Institute of St. Michael’s
Hospital
mamdanim@smh.toronto.on.ca
2:50pm
Discussion – Case Studies
Workshop facilitators, Robert Leitch & Fern Levine – Health
Canada
3:30pm
Global Comparisons
Mary Wiktorowicz, York University
mwiktor@yorku.ca
A COPY OF THE FULL REPORT “Assessing
International Pharmacosurveillance Strategies:
Lessons for Canada.” is available on
the Canadian Patient Safety Institute (CPSI)
website
4:00 pm to 4:30 pm
Global comparisons – Discussion
Workshop facilitators, Robert Leitch & Fern Levine – Health
Canada
Day 2 - Friday May 23, 2008
9:30 am
Objectives – Day 2
Noralou Roos, University of Manitoba
Noralou_Roos@cpe.umanitoba.ca
9:35 am
Panel Discussion – International Perspectives
Ralph Edwards, World Health Organization, Uppsala Monitoring
Centre via teleconference
Ralph.Edwards@who-umc.org
David Henry, Institute for Clinical Evaluative Sciences (ICES)
Australian Perspective
david.henry@ices.on.ca
David Blumenthal, Member U.S. Institute of Medicine (IOM)
committee “The Future of Drug Safety” via teleconference
DBLUMENTHAL@PARTNERS.ORG
10:20 am
Panel Discussion
11:10 am Types of Evidence needed to Support Decision Making
Bob Peterson, University of British Columbia
bpeterson@cw.bc.ca
11:30 am
General Discussion – morning session
12:30pm
Charge to break out group
Workshop facilitators, Robert Leitch & Fern Levine – Health
Canada
12:40 pm
Breakout groups
“How can PMDSE data generated by the research network be used to strengthen decision making practices in drug safety and effectiveness in a (1) regulatory context and (2) drug plan management context?”
1:40 pm
Break out group report
2:30 pm
General group discussion
3:15 pm
Workshop Summary
Daniel Krewski, University of Ottawa
Online presentations from the PMDSE Workshop are subject to copyright protection. Permission from the speaker is required prior to any copying, reproducing, or rebroadcasiting any portion of the speaker’s presentations.
Other relevant documents and links for Post-Market Drug Safety and Effectiveness
- Workshop on Knowledge Translation in the Post Market Evaluation
of Post Market Drug Sagety and Effectiveness Data
http://www.mclaughlincentre.ca/events/knowledge/index.shtml
- Business case for Post-Marketing Surveillance Strategy
http://www.hc-sc.gc.ca/hcs-sss/pubs/pharma/2007-med-work_eff/index-eng.php
- Invitational
Workshop on Priority Research Projects for a Drug Safety and Effectiveness
Network
http://www.hc-sc.gc.ca/hcs-sss/pharma/nps-snpp/securit/workshop-atelier-priorit/index-eng.php
- International dialog on the Public Reporting Of Clinical Trial
Outcome and Results: PROCTOR meeting
http://www.cihr-irsc.gc.ca/e/36290.html
Workshop support:
Canadian Institutes of Health Research (CIHR)/ Expensive Drugs for Rare Diseases
Initiative
The PMDSE workshop was organized by a steering committee:
Workshop Steering Committee:
Boscoe, Madeline, Canadian Women’s Health Network
Chapman, Sheila, CIHR
Fraser, Brent, Ministry of Health and Long Term Care, Ontario Public
Drug Programs
Gray, Jean, Professor Emeritus, Dalhousie University
Henry, David, ICES
Krewski, Daniel, University of Ottawa
McMahon, Meghan, IHSPR-CIHR
McMurchy, Dale, IHSPR-CIHR
Morgan, Steve, UBC
Peterson, Bob, UBC
Reid, Susanne, Health Canada
Roos, Noralou, University of Manitoba
Sketris, Ingrid, Dalhousie University
Sunstrum, Cynthia, Health Canada
Tamblyn, Robyn, McGill University
Tierney, Mike, CADTH
Wiktorowicz, Mary, York University
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