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Speaker Profile


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, Investigator and staff GCP training, and medical monitoring in both drug and device studies.

Upcoming Webinars
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Recorded Webinars
Why is Drug Induced Liver Injury an Important Mirror of Drug Safety
The recent media publicity of the FDA warnings about the OTC drug acetaminophen, which is the most common drug cause for liver transplants, has brought into focus the effects of drugs on the liver.
Recorded August 12, 2009 ,
$295.00

What is the role of Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How?
All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol.
Recorded ,
$295.00

The Secret of Study Conduct Documentation to ensure 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.
Recorded ,
$295.00

How does compliance with 21 CFR Part 11 help ensure data integrity and subject safety in clinical research
Electronic medical records and electronic handling of study data is increasingly common.
Recorded ,
$295.00

How the Investigator's responsibilities and Legal commitment's in drug and device clinical research affects Study Conduct – The FDA point of view
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.
Recorded ,
$295.00
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