R Consortium R Submissions Working Group

Minutes of 12-07-2020 Meeting prepared by Joseph Rickert

View Attendee List

Joseph Rickert - R Consortium
Adrian Waddell - Roche
Doug Kelkhoff - Genentech
Bob Engle - Biogen
Juliane Manitz - Emd Serono
Lyn Taylor - Phastar
Mike Stackhouse - Atorus
Paul Schuette - FDA
Sascha Ahrweiler - Bayer
Sean Lopp - RStudio
Tadeusz Lewandowski - Roche
Yilong Zhang - Merck
Paulo Bargo - Janssen
Andy Nicholls - GSK
Keaven Anderson - Merck
Kevin Bolger - Procogia

Joseph Rickert opened the meeting and provided a brief overview of R Consortium Working Group concerned with Pharma related topics:

Paul Schuette of the FDA then gave a brief overview of FDA Submissions Infrastructure. He described:

Adrian Waddell asked how flexible the FDA was willing to be on this infrastructure and whether it could be negotiated. Paul Schuette indicated that negotiation was possible. Thereafter, followed a robust discussion which was recorded and available at this link. The pass code is yif%qn4p.