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The GCP-ICH Obligations of Sponsors, Monitors, and Investigators - Barriers and Solutions Date: Tuesday, July 09, 2013 Duration:
90 Minutes
Time: 10:00 AM PDT | 01:00 PM EDT Location: Online
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Instructor: Charles H Pierce
Overview: There is an increasing frequency of real-time FDA Audits of trials and it seems that no one is well prepared. It is the obligation of the major players in the drug development process (the Investigator and the study Sponsor) to be sure studies are carried out correctly so that errors and mistakes are found and corrected by them (CAPA) and not by an FDA Investigator.
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The historical background of why the GCP standards were developed Who is responsible for what The ICH definition of "GCP" and how it is applied The Regulatory requirements to follow to be GCP compliant Who, in the clinical research team is responsible that GCP is followed? How to be sure CPU / Site staff know their role in maintaining GCP
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Principal Investigators and sub investigators Clinical Research Scientists (PKs, Biostatisticians) Safety Nurses Clinical Research Associates (CRAs) and Coordinators (CRCs) Study Monitors Recruiting staff QA / QC auditors and staff Clinical Research Data managers.
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About Speaker Charles H Pierce Consultant, Clinical Research / Drug-Device Development Charles H Pierce MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been in the Clinical Research Industry for 20 years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, ... more
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