How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant? (March 10, Thursday 11:00 AM PST | 02:00 PM EST)

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

For More Information:
Note: Use this promocode(117660) for 10% discount.