With Michael A. Pierro in our Virtual Classroom - Register Now!
Next Course Date
October 28 - 31, 2024 Lived Stream Classroom 7:00 to 12:00 ET / 12:00 to 17:00 CET |
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| For over 12 years, Michael A. Pierro has provided consulting services to the Biotechnology, CRO and Pharmaceutical Industry in the areas of clinical operations (Standard Operating Procedures, Project Management and Clinical QA GCP auditing) and GCP/SOP training (live & Internet delivery). In this work, he draws on over 35 years of experience in clinical research and training in the pharmaceutical industry. |
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Course runs 7:00 to 12:00 ET / 12:00 to 17:00 CET 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. |
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Upon completion of this course, each participant will have a thorough understanding of the latest updated GCP requirements for monitoring and oversight of clinical trials described by FDA and EU Regulations, ICH and ISO Requirements for Sponsors, Monitors, and Investigators. In addition, the significance of these regulations will be correlated to protocol and case report form development for all phases of clinical research. Information regarding in-field and in-house auditing (i.e., Quality Assurance (QA) procedures compared to FDAs Bioresearch monitoring system) will be presented. Investigational Review Boards (IRBs) and Informed Consent (IC) as required by the FDA and ICH regulations are discussed in detail and compared with GCP and ICH regulations. |
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