Regulatory Science Symposium: Monitoring and Auditing Session 4: Sponsor Audits: Data Handling and Reports (2016)
In this series, we will discuss what a sponsor does with data after a clinical trial finishes at a site, focusing on audits.
Regulatory Science Symposium: Monitoring and Auditing Session 3: Auditing GCP Systems for Data Integrity (2016)
In this series, we will discuss data integrity, GCP systems, regulatory framework enforcement, and auditing for data integrity
Regulatory Science Symposium: Monitoring and Auditing Session 2: FDA Inspections - Getting Ready (2016)
In this series, we will discuss regulatory complexities regarding clinical trials.
Regulatory Science Symposium: Monitoring and Auditing Session 1: Introduction to Monitoring, Auditing, and FDA Inspections & GCP (2016)
In this series, we will discuss regulatory complexities regarding clinical trials.
Clinical Trials Hurdles Session 5: Clinical Trial Data Disposition, Results, and Transparency Group (2015)
In this series, we will discuss how to successfully support and manage clinical trials
Clinical Trials Hurdles Session 4: Trial Master Files (2015)
In this series, we will discuss how to successfully support and manage clinical trials.
Clinical Trials Hurdles Session 3 : FDA GCP Inspections (2015)
In this series, we will discuss how the FDA investigators would conduct their GCP investigation.
Clinical Trials Hurdles Session 1 and 2: Challenges of Clinical Trial Management (2015)
In this series, we will discuss how to successfully support and manage clinical trials.