Archives: Agenda
Generating credible clinical evidence with limited budgets
- Prioritising evidence that meaningfully advances regulatory and clinical credibility
- Leveraging publications, partnerships and existing data without inflating costs
- Practical tips and insights on structuring FDA interactions and study design to maximise impact with constrained resources
Afternoon Refreshments, Networking & Prize Draw
Chairman’s Closing Remarks & Drinks Reception
Close of Conference
INTERACTIVE BOARDROOM SESSION
How it runs: A brief 10-minute “problem statement” is presented by the moderator, followed by a 30-minute collaborative “whiteboard” session where the group drafts a potential framework or solution. At the end each table will summarize their potential solutions.
Running device-intensive trials in specialty site networks without breaking workflows
- Managing diagnostic and device complexity at site level
- Addressing sponsor–site misalignment early
- Practical tips for improving feasibility and retention
Using updated FDA RWE guidance by building fit for purpose data strategies
- Choosing when RWD can credibly support device regulatory questions
- Establishing data quality, provenance, and governance requirements
- Designing hybrid evidence packages combining trials and RWE
Lunch & Networking
MDR survival guide: why regulatory and clinical can’t ghost each other
- Home Market Approval ≠ EU Readiness
- Can you reuse your clinical data and what to take care off?
- Clinical evidences is not a one time work… it is a lifecycle work under MDR