PPT-Quality Issues for Clinical Trial Materials

The Chemistry Manufacturing and Controls CMC Review Dorota Matecka PhD Office of Pharmaceutical Quality OPQ CDER Outline Pharmaceutical Quality CMC Requirements for INDs CMC Safety Concerns. Presented by:. Jo Greengrass, Deputy Director of Nursing, Quality & Safety. Simon Hawkins, Quality Improvement Support Manager. A Brief Background. Since July 2013 Clinical Concerns has dealt with over . By- Dr. . Sushrut. . Varun. . Satpathy. MBBS, MD. Assistant Professor. Department of Pharmacology. Sikkim . Manipal. Institute of Medical Sciences . Good . Clinical Practices:. An overview. 28. th. 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. Susan S. . Ellenberg. , Ph.D.. University of Pennsylvania. SCT/ICTMC Joint Meeting. Liverpool, UK. May 8, 2017. CLINICAL TRIALS TIMELINE. 1948: First randomized clinical trials of modern era. 1962: Amendments to U.S. Food, Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. CLINICAL TRIALS IN THE TWENTY-FIRST CENTURY: ONGOING CHALLENGES AND EMERGING ISSUES Susan S. Ellenberg , Ph.D. University of Pennsylvania SCT/ICTMC Joint Meeting Liverpool, UK May 8, 2017 CLINICAL TRIALS TIMELINE Industry and CRO Perspective on Clinical Trial Quality David J. Hewitt Vice President of Medical and Scientific Affairs Vice President and Global Head MSA Neurology and Pain IMMPACT June 2015 Currently working for inVentiv Health a CRO/CCO Susan S. . Ellenberg. , Ph.D.. University of Pennsylvania. SCT/ICTMC Joint Meeting. Liverpool, UK. May 8, 2017. CLINICAL TRIALS TIMELINE. 1948: First randomized clinical trials of modern era. 1962: Amendments to U.S. Food, Drug and Cosmetic Act requiring demonstration of efficacy as well as safety. “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 No policies existed to make sure that the public had access to results from unpublished NIH-funded research . What is the Patient Engagement Open Forum. A series of virtual events (in 2020) where we will work together, in a multi-stakeholder context, . to turn patient engagement into reality. .. The Forum aims to provide . Monitoring concepts and CRC development training. Amelia Spinrad, MS 18’ . Eunjoo Pacifici, . PharmD. , PhD. Nancy Pire-Smerkanich, . DRSc. , MS . USC Southern-California Clinical and Translational Sciences Institute . 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?. 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. Lalitha K. Shankar, MD, PhD,. Cancer Imaging Program, NCI. March 26, 2018. NCI Planning Committee. Jeff Abrams, Barry Kramer, Paul Jacobsen (DCTD, DCP & DCCPS) . Lalitha Shankar, Bhupinder Mann, Carmen Allegra, Shakuntala Malik, Larissa Korde, Nita Seibel, Worta McCaskill-Stevens and Anne Menkens. 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.