PPT-The IND and Clinical Trial Management

Frances Richmond Director International Center for Clinical Trials And you are The principal investigator of a companysponsored trial The principal investigator of an investigatorsponsored trial. Week 1 2 2 3 4 5 5 6 7 8 8 9 10 11 11 12 13 14 14 15 Ind team ind team ind team ind team ind team Mountain biker Vince Steger 25 12.5 12 49.5 Ron Knutowski 24 12 11.5 47.5 Jim Toombs 23 11.5 11 45.5 J 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. 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. : . The Chemistry, Manufacturing and Controls (CMC) Review. Dorota Matecka, Ph.D. . Office of Pharmaceutical Quality (OPQ), CDER. Outline. Pharmaceutical Quality. CMC Requirements for INDs . CMC Safety Concerns. Leonard Sacks. Office of Medical Policy. CDER, FDA. 2. Mission of regulatory agencies. Protection of people. Most countries in the world have regulatory institutions. Various levels of complexity. 3. Fortæl om en eller flere konkrete opgaver hjemmefra, der er løst (. fx plænen er slået/der er lukket for vandet i sommerhuset. ). . Fokus. : . Støt talen ved [. de vigtigste IND-teknikker repeteres sammen. NOTE A stay is in effect for partsof subsection VID of this guidance dditional information about this staycan be found inthe Notice of Stay that published in the Federal Registerof October 30 201580 Infoshort. August 2013. IND. An Investigational New Drug is a drug that has not yet been approved by the FDA for marketing and is available only for use in research to determine safety and effectiveness.. M P Vijay Kumar . FCA, FCMA, FCS. INSURANCE !!. This presentation should only be read along with the text of . Ind. AS. . The views expressed are those of the presenter and, therefore, do not necessarily represent the views of either the Council or any Committee(s)/Board(s) of the Council of the Institute of Chartered Accountants of India (ICAI).. “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 No policies existed to make sure that the public had access to results from unpublished NIH-funded research . Preparing an IND Application: CBER Breakout Session. Donald W. Fink, Jr., Ph.D.. Division of Cellular and Gene Therapies. Office of . Tissue and Advanced Therapies. Center for Biologics Evaluation and Research. 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.