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
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
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