| PhotosOctober 29, 2008
Westin Gaslamp Quarter Hotel
San Diego, CA
Presentation Slides & Schedule
Slides for select presentations below have been provided by the corresponding speaker for your convenience.
Please click the next to the speaker's name to log in to view the presentations.
| Wednesday, October 29, 2008 | |
| 11:00 am - 7:00 pm | Registration Open |
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| 1:00 pm - 1:20 pm | Welcome and Introductions |
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Ulrich Kalinke, PhD - Paul-Ehrlich-Institut, Germany Raj K. Puri, MD, PhD - U.S. Food and Drug Administration, CBER |
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| United States: Regulatory Considerations in Oncology Biologics Product Development | |
| 1:20 pm - 1:50 pm |
FDA: Chemistry, Manufacturing and Controls (CMC) Issues for Investigational New Drugs (IND) Keith Wonnacott, PhD - Food and Drug Administration
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| 1:50 pm - 2:20 pm |
FDA: Perspective on the Preclinical Evaluation of Biological Therapies for Cancer Yongjie Zhou, MD, PhD - Food and Drug Administration, CBER
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| 2:20 pm - 2:50 pm |
Introduction to FDA Drugs and Biological Review Process Ke Liu, MD, PhD - Food and Drug Administration, CBER
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| 2:50 pm - 3:15 pm | Break |
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| Europe: Regulatory Considerations in Oncology Biologics Product Development | |
| 3:15 pm - 3:50 pm |
European Medicines Agency: New Regulations for Advanced Therapies including Oncology Biological Products Patrick Celis, PhD - European Medicines Agency
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| 3:50 pm - 4:25 pm |
Paul-Ehrlich-Institut: Considerations in Product Development with Advanced Therapies and Cancer Vaccines Thomas Hinz, PhD - Paul-Ehrlich-Institut, Germany
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Japan: Regulatory Considerations in Oncology Biologics Product Development |
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| 4:25 pm - 5:00 pm | Cancer Vaccines and Immunotherapy Regulation Masatoshi Narita - Pharmaceuticals and Medical Devices Agency, Japan |
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| Global Regulatory Considerations in Oncology Biologics Product Development | |
| 5:00 pm - 5:30 pm |
Gina Coleman, MD - Health Canada Bindu Dey, PhD - Department of Biotechnology, Government of India Jianhui Luo, MD - Center for Drug Evaluation, SFDA, P.R.China Andreas Marti, PD, PhD - Swissmedic, Swiss Agency for Therapeutic Products
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| Roundtable Discussion | |
| 5:30 pm - 6:30 pm |
Moderators: Ulrich Kalinke, PhD - Paul-Ehrlich-Institut, Germany Raj K. Puri, MD, PhD - U.S. Food and Drug Administration, CBER Panelists: Ashok M. Batra, MD - U.S. Food and Drug Administration, CBER Patrick Celis, PhD - European Medicines Agency Gina Coleman, MD - Health Canada Bindu Dey, PhD - Department of Biotechnology, Government of India Thomas Hinz, PhD - Paul-Ehrlich-Institut, Germany Jianhu Luo, MD - Center for Drug Evaluation, SFDA, P.R. China Koji Kawakami, MD, PhD - Japan Science and Technology Agency Ke Liu, MD, PhD - U.S. Food and Drug Administration, CBER Andreas Marti, PD, PhD - Swissmedic, Swiss Agency for Therapeutic Products Masatoshi Narita - Pharmaceuticals and Medical Devices Agency, Japan Keith Wonnacott, PhD - U.S. Food and Drug Administration, CBER Yongjie Zhou, MD, PhD - U.S. Food and Drug Administration, CBER |
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| Reception | |
| 6:30 pm - 8:00 pm | Open to registered attendees for the Global Regulatory Summit |
All presentations are licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
