3:15 pm – 5:30 pm Innovative Approaches for Postmarket Evaluation: At the Cutting Edge
3.15 pm Contemporary postmarket for medical devices MDEpiNet- DanicaMDEpiNet Danica
3:45 pm IDEALpm IDEAL recommendations for Stage 4 (TBD- IDEAL UK)
4:15 pm Structuredpm Structured small group discussion of post-market
[organized into stakeholders groups: FDA/regulatory, IDEAL, industry, users].
Points to discuss
- Desirable characteristics of robust system
- Strengths and Weaknesses of current system
- Strengths and weaknesses of IDEAL recommendations
- Barriers to change
[Moderator to ensure discussion touches on each point and recorder summarizes agreement and disagreement]
5:00 pm Report from groups [each group facilitator/chairperson presents on behalf of group]