|
Agenda for Joint Initiative Open Forum Rotterdam
10 October 2010 1400 - 1830
Joint work (1400 – 1500)
- reports from project leads, including reports on
- Biomedical Research Information Domain Group Model
- Integrated Case Safety Report
- Identification of Medicinal Product
- EHR Functional Model
- Clinical Trials Registry
- Data Types
- Glossary and Document Registry (SKMT)
- GS1 Identifier
- Q+A
Report from the Joint Initiative Harmonization track (1500 – 1545)
- work being prepared, including reports and introductions on
- Detail Clinical Models / Clinical Data Modeling
- Data Types Implementation Guide
- ISO Privacy Steering Committee
- Detailed Clinical Models
- Generic model for Dose syntax
- Q+A
Coffee Break (1600 - 1630)
Session on Software as Medical Devices (1630 – 1830)
As requested during the JI Harmonization Track in Rio we will allocate time to discuss the impact of directives / decisions to classify software as a medical device (SAMD).
Speakers will be announced later.
There will also be a timeslot for SAMD in the Joint Initiative Harmonization Track (tba)
|
