iSBTc Webinar - Global Regulatory Summit: Considerations in the Development of Oncology Biologics Products for the Treatment of Cancer

Program Description

This webinar provides participants a unique opportunity to hear from regulatory representatives from around the globe regarding the development of oncology biologics products. This webinar was created from the live program which was held in conjunction with the iSBTc 23rd Annual Meeting in San Diego, CA in October 2008. To view the live program information, including speakers, click here.

The Webinar features insight on regulatory agency protocols and requirements as presented by representatives from:

• U.S. Food and Drug Administration (FDA)
• European Medicines Agency
• Japan Science and Technology Agency
• Pharmaceuticals and Medical Devices Agency, Japan
• Center for Drug Evaluation, SFDA, P.R. China
• Paul-Ehrlich-Institut, Germany
• Department of Biotechnology, Government of India
• Health Canada

This webinar consists of video-taped presentations by each speaker synchronized to their slide-set as it appeared during the program. This webinar will be available for viewing online at no cost through October 2010. A CD-ROM of this program is available for a minimal fee by clicking the "Purchase CD-ROM" button above. By purchasing the CD, you'll be able to keep this valuable tool and view it at anytime.

Intended Audience

The target audience for this webinar is clinicians, industry representatives, government representatives, translational and basic scientists, graduate students, post-doctoral fellows, as well as other allied health professionals who are involved in clinical trials in the area of oncology biologics product development.

Objectives

1. Viewers will understand the key regulatory challenges for first-in-human oncology biologics trials
2. Viewers will be able to identify immunological endpoints in pre-clinical and clinical studies for cancer vaccines
3. Viewers will better understand and appreciate the requirements for accelerated approval or conditional marketing authorization for promising new biologics

The Global Regulatory Summit Webinar has been funded through an educational grant from the Bristol-Myers Squibb Company and funding from the Center for Cancer Research, National Cancer Institute.