概要
For many organisations, clinical trial regulatory inspections are obligatory for achieving new, or maintaining existing market authorisations. However, it can be challenging for organisations to sustain the required level of Trial Master File (TMF) preparedness while simultaneously dealing with data integrity, data privacy and Good Clinical Practice (GCP).
This course shares with you TMF management and oversight strategies for ensuring that you can sustain your TMF inspection readiness throughout the clinical trial development process.
Using practical examples, we will provide insights into helping your organisation prepare your TMF for an inspection in this digital era.
We will also show you those areas of TMF quality, data integrity and process improvement where you should focus your attention if you are to be ready to meet specific EMA, FDA and MHRA requirements.
Participant Testimonials
Very good training. Very good trainers. The contents and trainers' knowledge covered my needs. This was more than an overview of the TMF management process, it helps improve your process. – Christopher Bushell King – Clinical Quality and Compliance Auditing Lead, UCB Biopharma SRL, Belgium
