PPT-European Clinical Trial Regulation 

Liz Philpots head of research AMRC Summary About me amp AMRC About the EU Clinical Trials Regulation whats new Implementation timeline What does this mean for UK ethicists AMRC established 1987. 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. Are you prepared . November 2015. A.N. Moult. Employment Disclaimer. The views and opinions expressed in the following PowerPoint slides are those of the individual . presenter. They . are . brought together as a result in participation in EFPIA Technical Development Expert Group and its Work . 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. DG Competition Case M.9301 - KDDI / MITSUBISHI SECURITIES / KABU.COM Only the English text is available and authentic. REGULATION (EC) No 139/2004 MERGER PROCEDURE Article 6(1)(b) NON - OPPOSITION Answers to Knowledge Check in the post-event surveySME and academia Clinical Trials Information System CTIS two-part training webinar day 2Classified as public by the European Medicines Agency Europe 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 No policies existed to make sure that the public had access to results from unpublished NIH-funded research . 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. Clínica Universidad de Navarra, Madrid. GEICO (Grupo Español de Investigación en Cáncer de Ovario). ENGOT (. European. Network of . Gynecological. . Oncological. . Trials. . groups. ). Who we are. 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.