1. Authority advice Why Where seek advice For todays case study
Optimize drug development strategy - Reduce time to market
Identify and avoid unnecessary studies
Ensure that necessary studies are designed to provide useful information
Gain authority support for a proposed strategy
Where seek advice
Regulatory agencies – EU national, EMA, FDA, PMDA
Combined advice meetings e.g. with HTA
May help to resolve national differences
For todays case study
EMA Scientific Advice

2. Scientific advice meeting
Meeting characteristics
Formal meeting
EMA delegation – 2 members (CBG_MEB and MHRA)
Duration: 30 minutes
Meeting agenda
Introduction company delegation (2 minutes)
Product development plan - presentation (5 minutes)
Discussion on company questions (23 minutes)
Be aware that……
Discussion of development strategy rather than pre-evaluation of data
Advice is not legally binding but …. expected to be followed

3. Scientific advice meeting
Prepare meeting
Clearly define endpoints and goals of the development program
Use background information to identify issues
Take guideline requirements into account
Phrase questions – care with wording, ask non-open questions
Phrase company position for each question
Establish back up positions
Agree meeting roles, including leadership
During the meeting
Formal meeting, behave accordingly
Check and confirm agreements / outcomes
Agree on next steps
Ensure common understanding