Meeting objective and question strategy
Define what the interaction must achieve and which questions genuinely change the programme.
DECISION LAB / HEALTH-AUTHORITY SPRINT
Enter the interaction with one sponsor position
VED aligns the questions, evidence, argument and team around an FDA, EMA or MHRA interaction—and translates the advice into programme action.
VED working method
- 01Position
- 02Prepare
- 03Implement
01
What VED can own
Sponsor positions
Build clear positions with evidence, assumptions, fallbacks and decision consequences.
Briefing direction
Set the narrative, content plan, review model and response discipline.
Team preparation
Run challenge sessions, rehearse responses and agree speaking roles and escalation points.
Advice implementation
Convert feedback into decisions, commitments, owners and controlled changes.
Global coherence
Keep regional advice connected to the global pathway rather than solving one market in isolation.
02
Typical interactions
- Pre-IND, Type B or Type C FDA meetings and relevant CBER interactions
- EMA scientific advice and protocol assistance
- MHRA scientific advice and UK development discussions
- Dose optimisation, expansion, registrational design and endpoint strategy
- Advanced-therapy, biomarker and diagnostic development interfaces
03
Engagement boundary
VED can lead the interaction strategy or reinforce an existing regulatory team. The scope states who authors, who approves, what evidence is in play and where specialist clinical, statistical, CMC, nonclinical or diagnostic input must be added.
Start with the constraint
What must your programme decide, prove or deliver next?
Share the situation, evidence and timing. We will propose the smallest credible first step.