Posted by Richard Tsai on Sep 12, 2013 11:30:00 AM
Do you have a cell based therapy in development? Have you had difficulty in meeting FDA criteria for cold chain or chain of custody requirements? Have you incurred unnecessary costs in your clinical trials due to cold chain regulations? The importance of understanding and evaluating packaging, storage, inventory management, monitoring systems, distribution, and clinical site capabilities cannot be undervalued. If these factors are not taken into the consideration early it can lead to problems with scalability and commercial viability.
We will provide answers to these questions in our webinar presented by Dan O'Donnell, Associate Director of Cell Therapy Logistics on October 10, 2013 from 11:00 AM to 12:00 PM (EST).
You will learn about:
- Challenges of moving high value biologics at ultra cold temperatures in clinical trials and the commercial marketplace
- Use a case study format to illustrate the technical challenges of meeting FDA requirements while moving products around the world at cryogenic temperatures
- Discuss with us in an open Q&A session about cold chain challenges and needs for cell-based therapies
Mr. O'Donnell will be sharing his best practices and case studies in ultra cold chain distribution and regulatory compliance in transporting biologics and cryogenically frozen cell-based therapeutics. Sign up for the webinar today!
Ultra Cold Chain & Logistical Challenges in Cell Therapy and Clinical Commercial Development
Date: Thursday, October 10th, 2013
Time: 11:00 - Noon EST (USA)
16:00 - 17:00 PM (UK)
If you did not attend the webinar, please click on the button below to view a recorded version of the Cell Therapy Webinar.