Online Program Home
My Program

CC = Vancouver Convention Centre   F = Fairmont Waterfront Vancouver
* = applied session       ! = JSM meeting theme

Activity Details

290 * ! Tue, 7/31/2018, 8:30 AM - 10:20 AM CC-West 301
Drug Safety Monitoring in a Complex World-Wide Regulatory Environment - Strategy Meets Methodologies — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Susan Duke, FDA/CDER/Office of Biostatistics
Chair(s): Amit Bhattacharyya, ACI Clinical
8:35 AM Quantitative Regulatory Landscape

Lothar Tremmel, CSL Behring
8:55 AM Going from the Program Safety Analysis Plan to the Aggregate Safety Analysis Plan

Barbara Hendrickson, AbbVie
9:15 AM Specific Safety Monitoring Tools and How This Will Benefit Drug Safety

James Buchanan, Covilance LLC
9:35 AM Discussant: Jonathan Seltzer, ACI Clinical
9:55 AM Floor Discussion