ComplianceOnline

The GCP/ICH Obligations of Sponsors, Monitors, and Investigators - Barriers and Solutions

Instructor: Charles H Pierce
Product ID: 701668
  • Duration: 90 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$499.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This GCP/ICH regulations training will focus on the regulatory requirements that Sponsors, Monitors, and Investigators must follow to be GCP compliant.

"This course is certified by Regulatory Affairs Professional Society (RAPS). Attendees of Live Webinar are eligible for 1.5 RAC Points up on full completion of the course."

Why Should You Attend:

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.

All of the players have responsibilities to insure both the integrity of the data collected but also, and most importantly, the safety of the human study subjects.

The 9 “Commitments” on the FDA Form 1572 serve as the PI’s guide to how “GCP” is viewed by the Regulatory Authorities. In addition the ICH E6 Guidelines very clearly spell out the responsibilities of both the sponsor (who in turn is responsible for monitoring of studies) and the Investigator. This webinar will ensure that you are clear as to what the practices are that ensure subject safety and credible data, which are the hallmarks of GCP.

Areas Covered in the Seminar:

  • 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?

Who Will Benefit:

This Webinar will provide invaluable assistance to the pharmaceutical industry and to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
  • 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

Instructor Profile:

Charles H. Pierce , MD, PhD, FCP, CPI Has 20+ years experience in bringing the message (via webinars, lectures and seminars) of Clinical Risk Management through knowledge 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. He has been involved in Investigator and staff GCP training, and medical monitoring in both drug and device studies.

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