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Risk-Based Monitoring and GCP Compliance in Pharmaceutical, Biologic and Medical Device Clinical Trials

 
  March 29, 2016  
     
 
Center for Professional Innovation & Education, Inc., Los Angeles, CA
July 13 & 14, 2016


This GCP compliance training course provides a solid understanding of GCP requirements and a clinical compliance overview for clinical trials. The FDA supports clinical trial sponsors to use risk-based site monitoring. That's a plus for many sponsors, but you have to have the quality risk management system in place to make it work. 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. This will include practical knowledge on how to implement a risk-based monitoring approach to quality in clinical trials.

Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites by maximizing risk-based considerations. 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.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers:

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.

 
Deadline for Abstracts: n/a
 
Registration: CLICK HERE TO REGISTER
E-mail: info@cfpie.com
 
   
 
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