ECG has leveraged its extensive FDA Advisory Committee experience and created solutions that allow client teams summoned to a meeting with Scientific Advisory Groups (SAGs) during their MAA review to have the security of comprehensive preparation and back-up slide support while meeting the mobile and shortened time-frame requirements of most SAG meetings.
Although all of ECG's consulting utilize intense audience analysis, in this case, because the standing members of a Scientific Advisory Group are typically medical and scientific experts from the EU with histories of their scientific opinions on matters related to the product available, ECG does extensive research on these opinions to help teams prepare. ECG has worked with clients on several Scientific Advisory Groups, and each has gone more smoothly with the strategic assistance and intellectual contributions of our Principals.
In many cases, ECG has seen success at SAG meetings lead to the elimination of Oral Explanations; companies succeed at answering the medical questions at hand effectively enough for the CHMP to finalize its opinion.
Please contact us or at +1-201-894-8200 to discuss how we can help you expertly prepare for your upcoming Scientific Advisory Group.