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

Agenda – January 26, 2018
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
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
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8. 10:45-11:05 Health Canada presentation – Draft guidance document overview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
*Times indicated are to be used as a guide for the Chairperson and are approximate.
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