Developed by: Philip Cesar B. Garay Jocebhel M. Bagares Farrah L. Arienza System Overview Scope of the System The system is designed with five (5) platform/module namely:…
Slide 1HELP! The FDA is Coming! Margaret M. Groves, JD, CRA Director, Clinical Trials Quality Assurance (CTQA) School of Medicine (SOM) Compliance Office Slide 2 Agenda What…
Slide 1 Long-Term Outcomes Using a Self- Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery: Two-Year Results From the CoreValve…
Slide 1 Imaging Assessment of Diabetic Foot Infections Regina Alivisatos, MD Medical Officer DSPIDPs Slide 2 Introduction Patients with osteomyelitis should be identified…
Planning and Execution of Learn-Phase Clinical Trials Parvin Fardipour Introduction The planning and execution of response adaptive randomization trials involves complexities…
Resistance and Tropism - Maraviroc Lisa K. Naeger, Ph.D. Division of Antiviral Products Food and Drug Administration April 24, 2007 FDA Antiviral Advisory Committee Meeting…
New Adverse Event Reporting Policy Effective September 1, 2007 Local adverse event reporting Local adverse events are those experienced by subjects enrolled by the investigator(s)…
Continuing Review Presented by: Karen Jeans, PhD, CCRN, CIP Program Analyst, COACH Objectives Describe what is meant by âcontinuing reviewâ Describe VA requirements for…
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