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Global Regulatory Summit


The SITC 2015 Presentation Archive is supported through a generous contribution from AstraZeneca/MedImmune.

Access slide decks and video via the links in the schedule below.

PDF = PDF of slides is available

VIDEO = Presentation video is available

Program Schedule

Wednesday, November 4, 2015

   
8:00 a.m. – 8:15 a.m. Welcome and Introductions
Ke Liu, MD, PhD – U.S. Food and Drug Administration
Patrick Celis, PhD – European Medicines Agency

General Introductions: Novel Science on Cancer Immunotherapies

8:15 a.m. – 8:45 a.m. Evolution and Future Predictions Part I  PDF  VIDEO
Ke Liu, MD, PhD – U.S. Food and Drug Administration
8:45 a.m. – 9:15 a.m. Evolution and Future Predictions Part II  PDF  VIDEO
Björn Carlsson, PhD – Medical Products Agency- Sweden

United States & Europe: Regulatory Considerations in Cancer Immunotherapy Product Development

9:15 a.m. – 9:45 a.m. U.S. Food and Drug Administration Perspectives
Peter Bross, MD – U.S. Food and Drug Administration
9:45 a.m. – 10:15 a.m. European Medicines Agency Perspectives  PDF  VIDEO
Patrick Celis, PhD – European Medicines Agency
10:15 a.m. – 10:30 a.m. Break

Asia: Regulatory Considerations in Cancer Immunotherapy Product Development

10:30 a.m. – 10:45 a.m. Japan Perspective  PDF  VIDEO
Sumimasa Nagai, MD, PhD - Pharmaceuticals and Medical Devices Agency, Japan
10:45 a.m. – 11 a.m. India Perspectives  PDF
Geeta Jotwani, PhD – Indian Council of Medical Research
11 a.m. – 11:15 a.m. Korea Perspectives
Gi Hyun Kim, PharmD – Ministry of Food and Drug Safety
11:15 a.m. – Noon Lunch

Panel Discussion

Noon – 1 p.m. Moderators:
Ke Liu, MD, PhD – U.S. Food and Drug Administration
Patrick Celis, PhD – European Medicines Agency

Panelists:
Geeta Jotwani, PhD – Indian Council of Medical Research
Sumimasa Nagai, MD, PhD – Pharmaceuticals and Medical Devices Agency, Japan
Peter Bross, MD – U.S. Food and Drug Administration
Allen Wensky, PhD – U.S. Food and Drug Administration
Björn Carlsson, PhD – Medical Products Agency - Sweden
1 p.m. Closing Remarks
Patrick Celis, PhD – European Medicines Agency

 

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Save the Date!

Save the dates for SITC 2016!
November 9 – 13, 2016
Gaylord National Hotel & Convention Center, National Harbor, Maryland

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