PPT-Industry and CRO Perspective on Clinical Trial Quality

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 CROCCO. Essential . and Virtuous Aspiration or . Mentoring . Virgins for the Whorehouse?. April 14th, 2014. David I. Quinn MBBS (Hons) PhD FRACP FACP. Associate Professor of Medicine. Chief, Section . f . GU Medical Oncology. cell based therapies in the UK. . Natalie Mount PhD. Chief Clinical Officer. Cell Therapy Catapult. Nov 2013. natalie.mount@ct.catapult.org.uk. UK Catapults. 2. Catapults . are core funded by the Technology Strategy Board as ‘not for profit’ companies to . to the . Integrity . of . Analgesic Clinical Trial . E. fficacy . D. ata. Sharon Hertz, MD. Division Director. Division of Anesthesia, Analgesia, and Addiction Products. FDA/CDER. Disclaimer. The content of this talk does not . 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. Erin Zook, PhD. Topics. My graduate and post graduate . c. areer . p. ath. Compare and contrast my experience in academia and industry. Academic Post-Doc vs. Intro position in industry. Application Process. : . 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. x0000x0000 x/Attxachexd /xBottxom x/BBoxx 7x2 21x036x 75 x368x04 x/Subxtypex /Foxoterx /Tyxpe /xPagixnatixon 0x/Attxachexd /xBottxom x/BBoxx 7x2 21x036x 75 x368x04 x/Subxtypex /Foxoterx /Tyxpe /xPagix “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 No policies existed to make sure that the public had access to results from unpublished NIH-funded research .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. 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.