How to Monitor Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance

By the end of this course, participants will have a detailed understanding of how to:

• Identify and define the principles and requirements for GCPs
• Define the roles and responsibilities of sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials
• Recognize clinical trial documentation differences for drug, device, and biologic studies
• Recognize how GCPs can impact clinical research programs
• Put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
• Understand what happens during a GCP inspection
• Detect and prevent fraud and misconduct in clinical trials
• Ensure that your data and supporting documentation are accurate and in the right format for inspectors

This GCP compliance training course provides a solid understanding of GCP requirements and a clinical compliance overview for clinical trials. Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites. This course teaches you how to ensure that your data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and interactive case studies. 

Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in drug development, clinical research and regulatory affairs for over 30 years. He has worked in pharmaceuticals, contract research, government, and biotech industries, in domestic and international regulatory affairs and clinical research. Dr. Hamrell also worked in the Division of AIDS in NIAID at the National Institutes of Health, and as a reviewer in the Center for Drug Evaluation & Research at the Food and Drug Administration (FDA), in the Divisions of Antiviral Drug Products, Oncology Drug Products, and Bioequivalence.

Dr. Hamrell spent a number of years doing basic research, first as a Research Fellow at Duke University and later as an Assistant Professor of Pharmacology at the McGill University Cancer Center. Dr. Hamrell has a Ph.D. degree in Pharmacology from the University of Southern California and a B.S. in Biochemistry from the University of California, Los Angeles. Dr. Hamrell has received numerous awards for his research, teaching and professional work and is recognized in Who's Who. Dr. Hamrell also holds an appointment as Adjunct Professor of Molecular Pharmacology and Toxicology at the University of Southern California School of Pharmacy, as Adjunct Associate Professor at the Massachusetts College of Pharmacy & Health Sciences, the School of Nursing at the University of North Carolina Wilmington and Adjunct Assistant Professor at George Washington University School of Medicine, Clinical Research Program.