To file or not to file an NDA Application: When GCP Noncompliance Compromises your Pivotal Trial 2014
08 Jul 2014
Webinar
Description
Topics
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
Who should Attend
Clinical Research Managers
CQA Managers
Regulatory Affairs
Project Management
Clinical Operations
Risk Management
Past Events
To file or not to file an NDA Application: When GCP Noncompliance Compromises your Pivotal Trial 2014 - 08 Jul 2014, Webinar (45455)
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
