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Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirements

  January 24, 2018  
CfPIE - The Center for Professional Innovation & Education, Boston, MA USA
November 7 - 9, 2018

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

This GCP training course is designed to provide individuals with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as, regulatory requirements.  The course consists of lecture and exercises designed to focus on the practical implementation of the GCP requirements.  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.  Participants will also discuss real life situations such as reviewing pre-study documents and informed consent form for completeness and compliance; conducting drug accountability; reviewing case report form for accuracy and adherence to protocol and performing source document verification.

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 for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and case studies.  The GCP training course will also provide the attendee with thorough knowledge of the following topic:

  • How drugs/biologics and devices are discovered and developed
  • The different phases of clinical research
  • What constitutes Good Clinical Practices (GCP)
    • How the requirements differ in the US, EU, India, China & Japan
  • The principles of ICH GCP
  • The IRB/IEC’s composition and role/responsibilities
  • The IRB study review & approval process
  • The role and responsibilities of the investigator & study site staff
  • The role and responsibility of the sponsor
  • Key requirements for GCP as defined by ICH and ISO Guidelines
  • Which sections of 21 CFR and ICH Guidelines govern conduct of clinical studies
  • The purpose for an IND / CTA and its composition
  • The IND/CTA reporting requirements
  • The requirements for Informed Consent
  • The process for Informed Consent review & approval
  • Risk based monitoring principles and goals
    • Designing and implementing a monitoring plan
    • The different types of study Monitoring visits & tasks
  • Adverse Events - the types and reporting requirements
  • How to perform product Accountability & compliance
  • How to detect and deal with potential fraud and misconduct
  • The purpose and composition of the marketing application
  • How marketing applications are filed, reviewed and approved
  • Sponsor responsibilities after approval
  • What happens during a FDA inspection

Who Should Attend

This three-day GCP training course is specifically designed for Clinical Operations Staff (Study Managers, Medical and Study Monitors) as well as GCP Auditors and others involved in conducting and monitoring and/or QA of clinical studies of new medications who require a working knowledge of the regulatory requirements (US and EU) and ICH Regulations for Good Clinical Practices (GCPs).  This three-day program will provide attendees with the training needed to improve clinical trials and ensure compliance with Good Clinical Practice, FDA Regulations, EU Directives and ICH Guideline.   

Clinical Research Managers and employees who work for Pharmaceutical or Biological firms, Contract Research Organizations, Medical Device companies and academic institutions involved with the supervision or oversight of clinical trial practices and policies will find this course of interest.  Other research professionals, (i.e., clinical investigators, research coordinators, regulatory and medical communications personnel) will also benefit from this GCP training program.

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

Michael R. Hamrell, Ph.D., RAC, FRAPS, RQAP-GCP

Specialties: Regulatory

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.

Other Courses:


He has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, computers and information systems. Dr Hamrell served as a founding Editorial Board member for Applied Clinical Trials and RA FOCUS, as the founding editor of the DIA Forum and as the Editor-in-Chief of the Drug Information Journal. He currently serves as a member of the Editorial Board of Applied Clinical Trials, Clinical Trials Advisor, ACRP Monitor and Editor-in-Chief of the GCP Q&A Reference Guide.

Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=301
E-mail: info@cfpie.com
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