Workshop Agenda
| Day 1 - Thursday May 22, 2008 | |
|---|---|
| 8:30 am 9:00 am to 9:05 am |
Continental breakfast Introduction and Welcome Daniel Krewski, University of Ottawa |
| 9:05 am to 9:10 am | Objectives - Day 1 Noralou Roos, University of Manitoba |
| 9:10 am to 9:30 am | A proposed Pharmacovigilance Network for Canada Steve Morgan, University of British Columbia |
| Regulatory Perspective in Canada Chair: Noralou Roos | |
| 9:30 am to 9:50 am | Federal Drug Regulatory Process Cindy Evans, Health Products and Food Branch, Health Canada |
| 9:50 am to 10:10 am | Progressive licensing Framework Karen Timmerman, Health Canada |
| 10:10 am to 10:15 am | Questions for clarification |
| 10:15 am to 10:35 am | Price Review Process for Patented Medicines Ginette Tognet, Patented Medicine Prices Review Board (PMPRB) |
| 10:35 am to 10:40 am | Questions for clarification |
| 10:40 am to 11:00 am | Coffee Break |
| Drug Coverage and Plan Management Perspectives Chair: Noralou Roos | |
| 11:00 am to 11:20 am | Common Drug Review (CDR) Mike Tierney, CADTH |
| 11:20 am to 11:25 am | Questions for clarification |
| 11:25 am to 11:45 am | Ontario Perspective Brent Fraser, Ontario |
| 11:45 am to 11:50 am | Questions for clarification |
| 11:50 am to 12:10 pm | Federal Drug Plan Management Perspective Susan Pierce, First Nations & Inuit Health Branch, Health Canada |
| 12:10 pm to 12:15 pm | Questions for clarification |
| 12:15 pm to 12:30 pm | General discussion |
| 12:30 pm to 1:30 pm | Lunch |
| Case Studies: Using Post Market Drug Safety Effectiveness Data in Decision Making Chair: Jean Gray | |
| Drug Plan Management: Coverage with Evidence | |
| 1:30 pm to 1:50 pm | Dementia drugs Neena Chappell, University of Victoria via teleconference |
| 1:50 pm to 2:10 pm | Chemotherapeutic agents Jeff Kirby, Dalhousie University and Judy McPhee, Nova Scotia Department of Health |
| Post-Market Risk Management | |
| 2:10 pm to 2:50 pm | Leveraging Data to Inform Health Decision-Makers: Examples (1) Aprotinin (2) Tequin (3) Core principals Muhammad Mamdani Applied Health Research Center, Keenan Research Centre Li Ka Shing Knowledge Institute of St. Michael's Hospital |
| 2:50 pm to 3:10 pm | Discussion - Case studies Workshop facilitators, Robert Leitch & Fern Levine - Health Canada |
| 3:10 pm to 3:30 pm | Coffee Break |
| 3:30 pm to 4:00 pm | Global comparisons Mary Wiktorowicz, York University |
| 4:00 pm to 4:30 pm | Global comparisons - Discussion Workshop facilitators, Robert Leitch & Fern Levine - Health Canada |
| 4:30 pm to 4:45 pm | Organization of break out group session Workshop facilitators, Robert Leitch & Fern Levine - Health Canada |
| 6:00pm | Group dinner - Johnny Farina (Italian) 216 Elgin St. |
| Day 2 - Friday May 23, 2008 | |
| 9:00 am | Continental breakfast |
| 9:30 am to 9:35 am | Objectives - Day 2 Noralou Roos, University of Manitoba |
| Panel Discussion: International Perspectives Chair: Steve Morgan | |
| 9:35 am to 10:20 am Opening remarks (15min. each speaker) Ralph Edwards, World Health Organization, Uppsala Monitoring Centre via teleconference David Henry, ICES (Australian perspective) David Blumenthal, Member U.S. Institute of Medicine (IOM) committee "The Future of Drug Safety via teleconference | |
| 10:20 am to 10:50 am | Panel discussion |
| 10:50 am to 11:10 am | Coffee Break |
| 11:10 am to 11:30 am | Types of Evidence needed to Support Decision Making Bob Peterson, University of British Columbia |
| 11:30 am to 11:45 am | General Discussion - morning session |
| 11:45 am to 12:30 pm | Lunch |
| Break out groups (in parallel) 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? | |
| 12:30 pm to 12:40 pm | Charge to break out group Workshop facilitators, Robert Leitch & Fern Levine - Health Canada |
| 12:40 pm to 1:40 pm | Break out group discussion (ROOMS 10161 & 11161) |
| 1:40 pm to 2:20 pm | Break out group report (4 groups) (10 min. each) |
| 2:20 pm to 2:30 pm | Coffee Break |
| 2:30 pm to 3:15 pm | General group discussion Workshop facilitators, Robert Leitch & Fern Levine - Health Canada |
| 3:15 pm to 3:30 pm | Workshop Summary Daniel Krewski, University of Ottawa |
| 3:30 pm to 3:35 pm | Next Steps Noralou Roos, University of Manitoba |
| 3:35 pm | Adjourn |
