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Charles H Pierce

Charles H Pierce, Keynote Speaker at Compliance Key INC. From an original Master's thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development. He is an APPI/APCR Certified Physician Investigator (CPI in 2003 and recertification's to 2016). He is frequently actively involved in Webinars, courses and workshops giving the clinical investigator and staff an understanding and appreciation of the ethics as well as the science and regulations governing clinical research with drugs or devices. The end must be knowledge and keen observation to ensure drug safety. Charles' active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU's). From experience and practical know-how the special needs of these units (from the floor plans to operational SOPs) has been of added value to those considering this venture. He has work experience in Device Studies and Pharmacovigilance. The later (PV) is of special interest as Phase I through Phase III do not guarantee drug safety. Actually this vigilance must start with the very first studies in human subjects.

 Webinar Id: CR0003
 View Anytime
 Duration 90 mins

The Secret of Study Conduct Documentation for a Successful Audit: What the FDA Inspectors Look for

All Clinical Research protocols have the procedures and processes needed to collect the data as it happens documented. The FDA guidelines and regulations for the conduct of research involving human subjects were developed to ensure complete and credible data and to safeguard the health and safety of human subjects. The ICH states: "All clinical trial information should be recorded, handled, and stored in a way that allows its accurate r........

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