Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Agenda January 26, 2018
Place: Holland Cross, Tower B, 2nd floor, Room 2048
Date and Time: January 26, 2018 at 8:00am to 4:00pm, EST
Chairperson: Robert DiRaddo
Science Policy Advisors: Daniel Yoon, Hripsime Shahbazian
Participants: SAP-SaMD members and Health Canada employees
| Item # | Time | Topic |
|---|---|---|
| 1. | 8:00-8:15 | Welcome and Opening remarks Celia Lourenco, Senior Executive Director, Therapeutic Products Directorate (TPD) |
| 2. | 8:15-8:30 | Introduction of Members, Review of Affiliations and Interests Declarations, Chair’s address, Review of Agenda Chair |
| 3. | 8:30-9:00 | Health Canada presentation Medical Devices Bureau, TPD |
| 4. | 9:00-9:30 | Regulator presentation United States Food and Drug Administration |
| 5. | 9:30-10:00 | Industry presentation Council of Canadian Innovators |
| 6. | 10:00-10:30 | Industry presentation MEDEC |
| 7. | 10:30-10:45 | Break |
| 8. | 10:45-11:05 | Health Canada presentation – Draft guidance document overview Bureau of Policy, Science and International Programs, TPD |
| 9. | 11:05-12:15 | Deliberations of Questions and Answers SAP-SaMD members |
| 10. | 12:15-1:00 | Lunch |
| 11. | 1:00-3:45 | Deliberations of Questions and Answers SAP-SaMD members |
| 12. | 3:45-4:00 | Closing Remarks and Adjournment of Meeting Chair |
| *Times indicated are to be used as a guide for the Chairperson and are approximate. | ||