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Live Webinar
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How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant
Date & Time: Tuesday, February 5, 2013
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Charles H Pierce
Location: Online
Price : $195.00
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Instructor Profile: Charles H Pierce Consultant, Clinical Research / Drug-Device Development
Overview: Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a wellwritten protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct. As the Principal Investigator is responsible for the conduct of the study according to the protocol she/he signed, it is imperative that they ensure that all staff know the protocol and follow it to the letter. If and when a deviation or violation of the protocol is found, meaning that the protocol was not followed (PNF) it must be reported, reviewed and acted upon for Corrective and Preventative Action (CAPA). Also, the differences between and differing significances of "Deviations" and "Violations" must be clearly understood by all persons involved in the conduct of clinical research studies.
Areas Covered in the Session:
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How to know when the protocol is not followed (PNF)? 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
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
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Click here to register for this webinar Who Will Benefit: l l l l l l l l l
Principal Investigators and sub investigators Clinical Research Scientists (PKs, Biostatisticians) Research managers Safety Nurses Clinical Research Associates (CRAs) and Coordinators (CRCs) Recruiting staff QA / QC auditors and staff tudy Monitors 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 MentorHealth About MentorHealth MentorHealth is a comprehensive training source for healthcare professionals. Our trainings are high on value, but not on cost. MentorHealth is the right training solution for healthcare professionals. With MentorHealth, healthcare professionals can make use of the best benefits relating to their professional training. MentorHealth www.mentorhealth.com 43337 Livermore Common, Fremont, CA 94539, USA
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