When does GCP Non-compliance at an investigator site compromise a regulatory submission?
October 26, 2012 - Palo Alto CA US
This webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application. Why Should You Attend: GCP Non-compliance at the investigator site remains the sponsor’s primary liability for the rejection of the regulatory application. Fifty percent of all FDA study related investigational site inspections incur some level of GCP noncompliance observations. Most of these GCP non-compliance observations do not result in a rejection of the sponsor regulatory application. Sponsors must be able to make this assessment. While risk management is a sponsor multi- functional process that begins before the study site is set; there is a single sponsor decision that exposes the sponsor to regulatory consequences beyond simply filing the study data in a regulatory application. The determination of GCP compliance, or the significance of any noted investigator non-compliance, should guide the decision to file the efficacy study data in a regulatory application, or not. This webinar will include a discussion of two real case studies with significant GCP non-compliance where sponsor regulatory, clinical, and ultimately management decisions were associated with two very different outcomes. One of these companies was the subject of a regulatory agency enforcement action and closed down. The other company successfully brought the study product through an approved NDA.