Inspection Trends and TMF Management Workshop Day
9:30 am - 10:00 am Morning Coffee
10:00 am - 12:00 pm Morning Workshop
The regulations governing clinical trials have not changed radically for several years, with the exception perhaps of the R2 update to ICH GCP. However, the focus of TMF inspections is constantly evolving. This workshop will identify some of the key issues that regulatory agencies seem to be focussing on, providing an opportunity for in-depth discussion to understand the perspective of the agencies. In addition, the workshop will provide an opportunity for attendees to raise specific TMF management topics from the conference for further detailed discussion.
Attend this workshop to:
-Understand how to proactively prepare for future TMF inspections
-Understand what actions need to be taken to be future-proof
-Get answers to difficult questions that were not resolved from the conference sessions or that arose as an outcome of the conference sessions