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