PPT-A clinical trial to evaluate the

pharmacokinetic characteristics of hepatitis B immunoglobulin used for prevention of hepatitis B recurrence after liver transplanation Gun Hyung Na 1 Seunghoon Han 2 Sung Ho Choi. Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. David N. Assis, MD. Assistant Professor of Medicine. Yale University. I have no disclosures relevant to this presentation.. Clinical Trials in PSC. PSC is a rare disease . 32,000 patients in the US. PSC has no proven and approved treatment. Anh Ninh, College of William and Mary. Outline. Introduction. The Inventory Positioning Problem. Description of the problem. Unique features. Basic of inventory management. Site Selection Problem. 2. The Balance from . A Medical Communicator’s Perspective. 6th Asia-Pacific . Pharma. Congress. July 11-13, 2016 Kuala Lumpur, Malaysia. Dr.Namrata. Singh. Director - Medical Services. Turcaoz. Health Care Solutions. Cynthia Monahan, MBA, . CIP. CRC . IRB Director. Karla . Damus. , PhD, MSPH, MN, RN, FAAN. Clinical Research Regulatory and Education Manager Administrator, BMC/BUMC ClinicalTrials.gov . NIH Policies. T. he . trial sponsor . compiles . a detailed clinical study report (CSR. ) after each clinical trial. . This report follows . a format laid down by the regulatory . authorities.. The CSR can be hundreds of pages long.. “Putting it All Together. ”. 1. Why the changes to NIH-funded studies involving human subjects?. No policies existed to make sure that the public had access to results from unpublished NIH-funded research . Marina Di Marco. Principal Neuromuscular Physiotherapist. The changing landscape of research in DMD. Emily Crossley and Alex Johnson (co-founders of Duchenne UK and parents of children with DMD) were disappointed that clinical trials were being turned down in the UK because of lack of capacity.. Mary Kay Koenig, MD. Associate Vice Chair for Clinical Research. Co-Director for the Tuberous Sclerosis Center of Excellence. Department of Pediatrics. Division of Child & Adolescent Neurology. University of Texas McGovern Medical School. Karen-Sue Carlson, MD, PhD. Associate Professor of Medicine. Division of Hematology and Oncology. Section Head and Medical Director of Acute Care. Medical College of Wisconsin. Milwaukee, WI. What are clinical trials?. PERFUSE Medical Research &. Clinical Trial Course. Clara Fitzgerald, MPH. The Importance of Clinical Trial Protocols. The Clinical Trial Protocol is the complete written description of, and scientific rational for clinical research studies. SESSION 8. Handout/Reference sheets:. Study Start-up. NIH guideline-study-start-up document. Study start-up Tips. SOP reference sheet from Session 9. Webinars:. Research 101, session 4. Research 102, session 4. A Feasibility Study. SciSIP. PI Conference, September 2012. Ernst R. Berndt. Iain M. Cockburn. MIT, Boston University, and . National Bureau of Economic Research. What?. Analysis of trends in costs of doing clinical trials. (ACTTION). Public-Private Partnership WITH THE FDA. Robert H. Dworkin, PhD. Professor of Anesthesiology, Neurology, and Psychiatry. Professor in the Center for Human Experimental Therapeutics. University of Rochester School of Medicine and...