Boston SDE 2014
This page is used to plan the upcoming Boston SDE in 2014.
|9:10-9:30||Dataset Validation||Majdoub, Biogen Idec|
|9:30-10:00||Dataset Validation||Paul Bukowiec, Takeda|
|10:30-11:00||Dataset/Program Submission||Ram Govindaraju (small molecule) /Mominul Islam (experience based for Vaccine studyfrom Vertex –probably large molecule)|
|11:30-12:00||Submission Documentation||Sally Cassells|
|1:00-1:30||Submission Documentation||????? DB looking|
|3:00 - 4:00||Wrap Up|
Data set submissions are an integral component of successful drug development. Serving as the basis for clinical approval, data provides the means in which the Agency can confirm the results as presented in the Clinical Study Report. Yet, data set submissions are a very misunderstood process with each company doing it differently and each FDA reviewer requesting it differently. At the PhUSE Boston Single Day Event on May 7th we will dive into three topics which cause confusion in the data set submission process; Dataset Validation, Submission of Data sets/Programs, Submission Documentation. The morning will be devoted to presentations from industry experts spanning large and small companies. In the afternoon we will benefit from the collective experience of the attendees and have open discussion on these three topics. Join us for an exciting day of learning, discussion and networking.
Biogen Idec, 14 Cambridge Center, Building 8 Auditorium, Cambridge MA 02142