Not Specified. Charles H Pierce, MD, PhD, FCP, CPI

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Profile

Enjoys making presentations and Webinars on a variety of GCP subjects such as Investigator Responsibility in Clinical Research, The Role of Adverse Event Determination and Reporting in Drug Safety, Data and Safety Monitoring Board set-up and use, Importance of Conflict of Interest Avoidance, What is "GCP", How to Document to have a good FDA Inspection, How to prepare for an FDA BIMO Inspection, The Importance of effective Phrmacovigilance.

Specialties

  • Developing Phase I, IIa Clinical Pharmacology Units (CPU) -
  • The safety of the results of Clinical Research - Phase IV (Pharmacovigilance)is essential
  • Clinical Research study conduct from the Regs to practice - including post-market safety
  • Giving Lectures and Webinars on the GCP of Clinical Research - Value of Lab and EKG results on subject safety - How to avoid Protocol Deviations - Importance of good Post-market Pharmacovigilance

2 results Found
Live Webinar

Importance of Protocol Deviations and Clinical Research

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. This talk, by ...

  • Basic & Advanced
  • 90 Mins
  • Jan 16, 2019
Recorded Webinar

Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How

Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices.  Depending on the nature of the test agent, the length of the study or the number of sites conducting the c ...

  • Basic & Intermediate & Advanced
  • 90 Mins