Slide 1Testing the performance of the two-fold FCS algorithm for multiple imputation of longitudinal clinical records Catherine Welch 1, Irene Petersen 1, Jonathan Bartlett…
Slide 1API Conference- March 2010- Beijing 1 Requirements for the Quality of API from FDA Perspective Brenda Uratani, Ph.D. FDA Assistant Country Director, China Slide 2…
Slide 1Twentieth Century Milestones in Clinical Research: Looking Back and Moving Forward Michelle Price, M.Ed. Department of Surgery UTHSCSA Grand Rounds – June 19 th,…
Slide 1 The Quality System (QS) Train is Moving Fast at FDA Lana L. Pauls, MPH Director, Quality Management Staff CDER/FDA Slide 2 2 Learning Objectives At the conclusion…
Slide 1 Biotech & Pharma Biomedical career opportunities in industry Slide 2 Overview Science at a Company vs. Academia Attributes for Success at a Company Biotech vs.…
Slide 1 1 Risk Management Programs FDA Experience and Evolving Guidance on Risk Management Practices Anne Trontell, M.D., M.P.H. Deputy Director CDER Office of Drug Safety…
Slide 1 A PHASE II TRIAL OF PERIFOSINE IN PATIENTS WITH CHEMO-INSENSITIVE SARCOMAS A SARCOMA ALLIANCE FOR RESEARCH THROUGH COLLABORATION (SARC) STUDY Study Update – November…