Webinars

PSI's Pharmaceutical Statistics Journal Club
In association with the DIA presents

Clinical Trail Safety Monitoring

7th September 2017
3:00 - 4:30pm BST

Sponsored by


US Dial in:+1 408 638 0968 Access code: 643 284 892
UK Dial in: 0203 695 0088

https://diaglobal.zoom.us/j/643284892

Discussant: Dr Ram Tiwari, FDA

Speaker: : Dr Patrick Schnell (The Ohio State University College of Public Health, Columbus Ohio)
A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data
Authors: Patrick Schnell, Greg Ball
Therapeutic Innovation – Regulatory Science, Vol 50(6), p833-838, 2016

Speaker: Dr Hui Quan (Sanofi, New Jersey)
Adaptive and repeated cumulative meta-analyses of safety data during a new drug development process
Authors: Hui Quan, Yingqui Ma, Yan Zheng, Meehyung Cho, Christelle Lorenzato, Carole Hecquet
Pharmaceutical Statistics, Vol 14, Issue 3, May/June 2015

For each of these published papers there will be a 20 min presentation by the author followed by a 20-25 min discussion

Papers available to view prior to the meeting on http://www.psiweb.org/events/journal-club and presentation slides will be available there to download a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the above website.

Click Here for the webinar flyer


Open to PSI and non-PSI members and DIA and non-DIA members – no need to pre-register. We encourage you to read these papers in advance so you get the most from this event. Where multiple people are dialling in from the same site, we encourage you to book a meeting room and dial in together. For further info/feedback, or if you would like to submit a question to the authors in advance of the meeting please contact journalclub@psiweb.org

 



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