2014 - To file or not to file an NDA Application: When GCP Noncompliance Compromises your Pivotal Trial

Instructor: Stephen Schwartz, CIC
Description:
Risk management is the operative system in the pharmaceutical product development process. 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 is 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.
Objectives of the Presentation:
How to confirm and enable the CQA conclusions
Which of the 7 GCP compliance objectives directly compromise data integrity
Which of the 7 GCP compliance objectives impact acceptability of the submission regardless of the integrity of the study data
How the management decision process determined the outcome in these cases
How to identify the risk factors associated with filing this data in a regulatory submission in terms
Of identification of the specific risks
Of evaluation of the liability of incurring those risks
Of exposure to those risks
How to determine the cost for NOT submitting the data
How to assure that the perspectives of investigator, the sponsor, and the regulatory agency are all part of the final decision
The role of the sponsor in causing the GCP non compliance for each of the cases
What sponsor risk management process applied proactively could have avoided this non compliance
What functions should be represented on the core team
Which function makes the final file/no file decision
Does management really want to know the bad news?
How the risks associated with filing the data compromised by the GCP non Compliance may vary from FDA, MHRA, EMA, and SFDA
If success is the best teacher- what worked and what did not work for these two companies.
Who can Benefit:
CQA Managers
Clinical Research Managers
Project Management
Regulatory Affairs
Risk Management
Clinical Operations
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