The Clinical Trials Transformation Initiative (CTTI) invites you to participate in a webinar hosted by the Quality by Design (QbD) Project team. QbD emphasizes building quality into a process from the beginning. Applied to clinical development, this approach prospectively examines the objectives of a trial and defines factors (key data and trial processes such as randomization) critical to meeting these objectives. This webinar is the second in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials. (Click here to view the first webinar in this series.)
Topic: Translating Quality by Design Principles into Practice, Part 2
Date: Wednesday, January 14, 2015
Time: 11:00 a.m. – 12:00 p.m. Eastern Standard Time (New York, GMT-05:00)
Agenda:
- CTTI QbD Project Overview by Ann Meeker-O’Connell, Senior Director, Clinical QA Strategy, Janssen
- Quality Management in Clinical Trials: Keeping it Simple by Sabrina Comic-Savic, MD, MPH Senior Director, GCP Compliance, The Medicines Company
- QbD – An Example from a Running CV Outcome Trial by Helene DuPui-Ekdal Director, Clinical Development, AstraZeneca
- Q & A
THIS WEBINAR IS OPEN TO THE PUBLIC. WE ENCOURAGE YOU TO FORWARD THIS INVITATION TO OTHERS WHO MAY BE INTERESTED IN LEARNING MORE ABOUT QBD IMPLEMENTATION.
To join the webinar on January 14, go to:
https://dukemed.webex.com/dukemed/j.php?MTID=m6674f0b144ed076e5afb9322a67442d9
Meeting Number: 738 965 414
Meeting Password: ctti
If you prefer to connect to audio only, you can join by phone at:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)
The playback of UCF (Universal Communications Format) rich media files requires appropriate players. To view this type of rich media files in the meeting, please check whether you have the players installed on your computer by going to https://dukemed.webex.com/dukemed/systemdiagnosis.php.
Mark your calendars. The QbD Webinar Series will continue on the following date:
Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)