Global Regulatory Considerations in the Development of
Oncology Biologics Products for the Treatment of Cancer
October 29, 2008
Westin Gaslamp Quarter Hotel
San Diego, CA
The Global Regulatory Summit will bring together the knowledge and insight of thought leaders at regulatory agencies from around the world to give a global perspective on regulatory considerations in the development of oncology biologics products for the treatment of cancer. Representatives from regulatory agencies in the United States, Europe, Germany, Japan, India, China and others will contribute to this program as members of the program committee and as faculty.
The Summit is designed to be a highly-interactive program complete with speakers from various regions of the world and a panel discussion involving not only the program speakers, but also invited experts from additional regulatory and related agencies. Speakers will focus their presentations on their country's regulatory perspectives and requirements as well as address audience questions. A panel discussion concludes the program and will address questions posed by both faculty members and the audience members in attendance.
Program Organizers |
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Raj K. Puri, MD, PhD
U.S. Food and Drug Administration, CBER
Katsutoshi Tanaka
Pharmaceuticals and Medical Devices Agency, Japan
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Ulrich Kalinke, PhD
Paul-Ehrlich-Institut, Germany
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Intended Audience
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.
Program Objectives
- Discuss current regulatory requirements and guidences that are available in different regions of the world for product development for oncology
- Discuss global regulatory considerations for product pre-clinical and clinical studies as well as clinical trial design and analysis issues for oncology biologics
- Discuss the latest clinical developments regarding application of biologic approaches and establish dialogue between academia, various government regulatory bodies and industry regarding global implications and future direction of oncology biologics development
- Promote scientific exchange of most recent advances and data in the biological treatment of cancer, as well as advances in basic cancer biology with relevance for anti-tumor immunity
Expected Outcomes
Upon completion of this meeting, attendees will have:
- Learned about regulatory oversight in different parts of the world, including the differences and similarities in regulatory approach in various countries
- Learned key regulatory and scientific issues related to product, pre-clinical and clinical study design and analysis in oncology product development
- Had opportunities to interact with representatives from various world regulatory bodies
- Learned about opportunities to participate in U.S. government's oncology biomarker qualification initiative
