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iSBTc 23rd Annual Meeting Global Regulatory Summit 

02-23-2018 12:23

The International Society for Biological Therapy of Cancer (iSBTc) 23rd Annual Meeting: Global Regulatory Summit: Global Regulatory Consideration in the Development of Oncology Biologics Products for the Treatment of Cancer
Wednesday, October 29, 2008
Westin Gaslamp Quarter Hotel in San Diego, CA

Program Organizers
Raj K. Puri, MD, PhD - U.S. Food and Drug Administration, CBER
Ulrich Kalinke, PhD - Paul-Ehrlich-Institut, Germany

Program Summary
The Global Regulatory Summit will bring together the knowledge and insight of thought-leaders at regulatory agencies from around the world in an effort to address regulatory barriers and to give a global perspective on regulatory considerations in the development of oncology biologics products for the treatment of cancer.

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 products development.

Presentations and video recordings are available based on permission from presenters.


#ClinicalTrials #PresentationSlides #AnnualMeeting #Vaccines 
#AlliedHealth #SITC #AlliedHealth #Clinician #Industry #Oncologist #Researcher #2008​​​​ 
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Chemistry, Manufacturing and Controls (CMC) Issues for I...   449 KB   1 version
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Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: FDA: Chemistry, Manufacturing and Controls (CMC) Issues for Investigational New Drugs (IND); Presenter: Keith Wonnacott, PhD - Food and Drug Administration, CBER; Date: Wednesday, October 29, 2008
 
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Pre-Clinical Issues   101 KB   1 version
Uploaded - 02-23-2018
Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: FDA: Pre-Clinical Issues; Presenter: Yongjie Zhou, MD, PhD - Food and Drug Administration, CBER; Date: Wednesday, October 29, 2008
 
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Clinical Issues   512 KB   1 version
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Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: FDA: Clinical Issues; Presenter: Ke Liu , MD, PhD - Food and Drug Administration, CBER; Date: Wednesday, October 29, 2008
 
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European Medicines Agency - New Regulations for Advanced ...   880 KB   1 version
Uploaded - 02-23-2018
Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: European Medicines Agency - New Regulations for Advanced Therapies Including Oncology Biological Products; Presenter: Patrick Celis, PhD - European Medicines Agency; Date: Wednesday, October 29, 2008
 
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Paul-Ehrlich-Institut - Considerations in Product Develop...   647 KB   1 version
Uploaded - 02-23-2018
Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: Paul-Ehrlich-Institut - Considerations in Product Development with Advanced Therapies and Cancer Vaccines; Presenter: Thomas Hinz, PhD - Paul-Ehrlich-Institut, Germany; Date: Wednesday, October 29, 2008
 
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Regulatory Considerations for Oncology Biologics Developm...   320 KB   1 version
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Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: Regulatory Considerations for Oncology Biologics Development in Japan; Presenter: Masatoshi Narita - Pharmaceuticals and Medical Devices Agency; Date: Wednesday, October 29, 2008
 
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Regulatory Considerations for Oncology Biologics Developm...   507 KB   1 version
Uploaded - 02-23-2018
Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: Regulatory Considerations for Oncology Biologics Developments in Canada; Presenter: Gina Coleman, MD - Health Canada; Date: Wednesday, October 29, 2008
 
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Regulatory Considerations for Oncology Biologics Developm...   243 KB   1 version
Uploaded - 02-23-2018
Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: Regulatory Considerations for Oncology Biologics Development in India; Presenter: Bindu Dey, PhD - Department of Biotechnology, Government of India; Date: Wednesday, October 29, 2008
 
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Regulatory Considerations for Oncology Biologics Developm...   151 KB   1 version
Uploaded - 02-23-2018
Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: Regulatory Considerations for Oncology Biologics Development for China; Presenter: Luo Jianhui, MD - Center for Drug Evaluation, SFDA, P.R. China; Date: Wednesday, October 29, 2008
 
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Regulatory Considerations for Oncology Biologics in Switz...   125 KB   1 version
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Meeting: iSBTc 23rd Annual Meeting - Global Regulatory Summit; Presentation: Regulatory Considerations for Oncology Biologics in Switzerland; Presenter: Andreas Marti, PD, PhD - Swissmedic, Swiss Agency for Therapeutic Products; Date: Wednesday, October 29, 2008
 
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