How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
10 Mar 2011
Webinar
In this GCP compliance webinar learn how to prevent and handle protocol deviations and violations
Areas Covered in the Seminar:
The Primacy of the study Protocol.
What are Protocol “Deviation” and other terms / categories.
The many cause of protocol deviations.
The Regulatory requirements for handling protocol deviations and violations.
The importance of documentation of protocol deviations as well as violations.
How to define and handle instances of PNF.
What is the reason different IRBs define deviations and violations differently.
What is the basis of the difference between a “Deviation” and a “Violation”.
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 / Sub-investigators.
Clinical Research Scientists (PKs, Biostatisticians,)
Safety Nurses
Clinical Research Associates (CRAs) and Coordinators (CRCs)
Recruiting staff
QA / QC auditors and staff.
Clinical Research Data managers
Past Events
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant? - 10 Mar 2011, Webinar (8652)
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant? 2026
Important
Please, check "How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?" official website for possible changes, before making any traveling arrangements
