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 first in a CTTI-hosted series designed to provide real-world examples of applying QbD to clinical trials.
Topic: Translating Quality by Design Principles into Practice
Date: Thursday, October 16, 2014
Time: 12:00 p.m. – 1:00 p.m. Eastern Standard Time (New York, GMT-05:00)
Agenda:
- CTTI Quality by Design Project Overview – Ann Meeker-O’Connell, Senior Director, Clinical Quality Strategy Team Lead, Janssen
- Pfizer Experience – Coleen Glessner, Vice President, Clinical Trial Process and Quality, Pfizer
- Seattle Genetics Experience – Marta Fields, Senior Director, Compliance and Quality Systems, Seattle Genetics
- 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 October 16, go to:
https://dukemed.webex.com/dukemed/j.php?MTID=m27634ad504de56e6e23456b195047753
Meeting Number: 731 417 196
Meeting Password: ctti
For those wishing to access the audio conference only, please dial 1-855-244-8681(access code: 731 417 196).
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 dates:
- Wednesday, January 14, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)
- Wednesday, April 15, 2015, 11:00 a.m. – 12:00 p.m. EST (New York, GMT-05:00)