PPT-1 Pediatric Clinical Investigator Training

GCP Tips on Clinical Trial Conduct and Preparing for FDA Inspection Susan Leibenhaut MD Office of Scientific Investigations OSI CDERFDA February 28 2019 Good Clinical Practice GCP. Drug companies are required to provide substantial evidence that the drug is effective This has generally been defined as at least 2 adequate and well controlled investigations or clinical trials FDA has been flexible within the statutory requiremen Overview of Pediatric Clinical Research Resources. April 8, 2016. Objectives. Understand the purpose of PEARLS. Identify key contacts from pediatric clinical research. Discuss educational and training opportunities . of the . Clinical Research . Team. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. Learning Objectives:. Name the required and possible members of the research team. Career. Henry Khachaturian, Ph.D.. Training Program Policy Officer. Division . of Biomedical Research Workforce . OEP. , OER, . NIH. hk11b@nih.gov. National Institutes of Health. 2. NIH is made up of 27 Institutes and Centers, each with a specific research . . . Trainee:. . . . Name. Trainer:. Mr. . Jean-Paul Eycken. CEO . FormaliS. SA. This ICH . E6(R2) . GCP Investigator Site Training meets . the Minimum Criteria for . NY State Sepsis Initiative Update. May 24. th. , 2017. Marcus Friedrich, MD, MBA, FACP. Medical Director. Office of Quality and Patient Safety. NYSDOH. Marcus.Friedrich@health.ny.gov. Disclosures. Nothing to report. Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Purpose:. To . provide an overview of Investigator Responsibilities and GCP. to study sites. x0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x0000Clinical Investigator Training Coursex0000x00008x/MCIxD 0 x/MCIxD 0 --- but the diagnosis of so n and Research or CBER conducting clinical research are also referred to as Good Clinical Practices or regulations for nonclinical laboratories compliance regulations during inspections sure that Based on ICH . E6. GCP Guidance (. Sections1.24. &. 6) . and 45 . CFR. 46: Protection of Human Subjects . Purpose:. To . provide an overview of Investigator Responsibilities and GCP. to study sites. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. Stephen . Klasko. , MD, MBA. President and CEO of TJU AND Jefferson Health System. Dartmouth CO-OP PBRN. January 26, 2020. ECHO. (Environmental influences on Childhood Health Outcomes) - . Mission & Vision. “To enhance the health of children for. generations to come (through)…”. ��2 &#x/MCI; 0 ;&#x/MCI; 0 ;teaching and research, they have little or no direct patient contact, unlike pediatric hematologistsoncologists. Other specialists with whom pediatri 1 For Competency Based Training Programme In F NB - Pediatric Intensive Care NATIONAL BOARD OF EXAMINATIONS Medical Enclave, Ansari Nagar, New Delhi - 110029, INDIA Email: mail@natboard.edu.in Phone: