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

  • 08 Jul 2014
  • Webinar

Description

To file or not to file an NDA Application: When GCP Noncompliance Compromises your Pivotal Trial 2014 is a webinar that covers topics such as:

  • How the management decision process determined the outcome in these cases
  • How to confirm and enable the CQA conclusions
  • How to determine the cost for NOT submitting the data
  • How to identify the risk factors associated with filing this data in a regulatory submission in terms
  • The role of the sponsor in causing the GCP non compliance for each of the cases
  • How to assure that the perspectives of investigator, the sponsor, and the regulatory agency are all part of the final decision
  • How the risks associated with filing the data compromised by the GCP non Compliance may vary from FDA, MHRA, EMA, and SFDA
  • What sponsor risk management process applied proactively could have avoided this non compliance
  • If success is the best teacher- what worked and what did not work for these two companies

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

  • Clinical Research Managers
  • CQA Managers
  • Regulatory Affairs
  • Project Management
  • Clinical Operations
  • Risk Management

Past Events

Important

Please, check "To file or not to file an NDA Application: When GCP Noncompliance Compromises your Pivotal Trial" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance, Risk Management
Health & Medicine: Medical device, Medical technology

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