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GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

 
  March 29, 2016  
     
 
Center for Professional Innovation & Education, Inc., Los Angeles, CA
July 11 & 12, 2016


This GCP training course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites.

Additionally, attendees will learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover misconduct, as well as, dealing with its consequences, while identifying proactive solutions to prevent further problems. Included in the course work are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation through presentation and interactive case studies.

Additionally, the course will cover methods to detect misconduct and deal with fraud in clinical trials by:

  • Defining the basic requirements of Good Clinical Practices
  • Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial
  • Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials
  • Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection
  • Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials
  • Building trial guidelines/structure which will easily identify any misconduct and which is capable of quickly addressing any issues that arise in order to avoid regulatory consequences
 
 
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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