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

Duration: 60 Minutes
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.
NDA Application
Product ID: 500335

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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  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
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Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
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Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Founder of Commonwealth Clinical Research Services (later as Solaris Research Corporation), a full service CRO from 1989 to 2009. He has a degree in microbiology/infectious disease. Steve worked in clinical project development for Pharma for 16 years and for 20 years as a CRO with experience in devices, biologicals, diagnostics, and therapeutics in most of the areas of clinical research for all study phases, as well as pre-clinical activities.

Steve has extensive field experience as a CRA and as a CQA auditor, He has expertise in Clinical Operations, including the functions of clinical monitoring, program management, product development, CQA, and inspectional operations. He has recently retired from Pharma where he was Sr Manager, Global Clinical Operations. His current activities as a consultant include CQA inspections and training, Gap Analysis Audits, and Clinical Project Oversight.

Steve has served on an IRB and has served as PI on several phase four studies. He has published a monthly international clinical trial conduct newsletter (2000-2008) and has been a frequent presenter of webinars, and seminars over a broad range of topics for FDA News and Thompson Publishing and Bioforum. GCP, Regulatory, and CQA training of academia, government (US and Canada), and pharma staff have been a large part of his activities since 1994.

His many years of experience and expertise and his interactive presentations enable participant interaction and exchange of information/options.
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