Live Webinar
on
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant
Date & Time: Tuesday, October 04, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Charles H Pierce
Location: Online
Price : $245.00
Register Now
(for one participant)
Instructor Profile:
Overview:
Charles H Pierce Consultant, Clinical Research / Drug-Device Development
This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing misconduct on the part of the investigator is handled.
Why should you attend: Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study. Forewarned is forearmed.
Areas Covered in the Session: l
How to know when the protocol is not followed (PNF)?
l
What is the difference between a protocol deviation and a violation? Importance of the "Protocol" in the number of deviations occurring How to ensure that the protocol will be followed exactly? What is in the Regs about following the protocol? When may the Investigator make changes in the protocol? What are the causes of Protocol Deviations and Violations? How are Protocol Deviations managed? Examples of Protocol Violations and Deviations
l
l l l l l l
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. ...more
Suggest a Topic
More Webinars
Your Necessity is our Priority
Click here to register for this webinar Who Will Benefit: l
Principal Investigators / Sub-investigators.
l
Clinical Research Scientists (PKs, Biostatisticians,) Safety Nurses Clinical Research Associates (CRAs) and Coordinators (CRCs)
l l l l l
Recruiting staff QA / QC auditors and staff. Clinical Research Data managers
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe