December 2014

Date Title Slides and Agendas
December 11, 2014 CIPA Update Workshop CSRC-HESI-SPS-FDA Meeting Slides and Agenda

Rechanneling the Cardiac Proarrhythmia Safety Paradigm- An Update_18 FEB 2015 (Synopsis of the Think Tank Meeting)

December 12, 2014 Can QT Assessment in Early Clinical Development be used to replace the TQT Study – Presenting Results from the Prospective IQ-CSRC Clinical Study Slides and Agenda


April 2014

Title Purpose Slides and Agendas
CSRC NOAC Reversal Think Tank The purpose of the meeting is to assess the benefits and risks associated with anticoagulation, the unmet medical needs for Novel Anticoagulant (NOAC) reversal agents, and to discern the various aspects which may influence development and regulatory decision-making; the goal is to reach consensus regarding potential development strategies for NOAC reversal agents. Slides and Agenda

March 2014

Title Slides and Agendas Synopsis
COPD Thinktank Meeting Slides and Agenda CV Safety and COPD Drug Development Think Tank Synopsis

February 2014

Title Purpose Slides and Agendas Synopsis
CSRC FDA ACC Outcome Think Tank Purpose of Meeting:  To understand the variables impacting the threshold for considering the need for Randomized CV Safety Outcome Studies, create a consensus regarding thresholds, and understanding other potential approaches to collect safety data Slides and Agenda Synopsis of Feb CSRC_FDA_ACC Outcome Think Tank Meeting