Whether we like it or not, inspections are a crucial part of clinical trials. It...
Phlexglobal will collaborate with Trial Master Files Europe 2015.
With regulatory authorities becoming stricter on incomplete TMFs, the fear of being dealt a ‘critical finding’ is driving the rapid advancement of eTMFs.
It is on this basis that Pharma IQ brings Trial Master Files Europe, creating a new industry platform for the development of best practices and ensuring regulatory compliance.
Join more than 70 TMF experts at Europe’s only case study driven TMF event and build upon real examples of successful TMF management and eTMF implementation.
The event will include:
- Phlexglobal’s Karen Roy, who will present an in-depth case study on how sponsors can work with CROs to achieve a centralised eTMF. Karen will be delving into managing expectations, contractual obligations, managing the process, options for contemporaneous integration and end of study transfer process
- Andy Fisher from MHRA gives expert insight into the MHRA’s expectations on TMF completeness, working through examples of common pitfalls and how to address them with a one hour session and Q&A
- TMF Reference Model Version 3 will be broken down in a workshop scenario with Eldin Rammell, looking at how it can be incorporated into a paper and electronic TMF system
- CSL Behring’s Markus Wotruba will break down the process of converting to an eTMF system, examining implementation processes, challenges and outcomes
- Lisa Pabion from Sanofi Pasteur will deliver practical examples on how to prepare for inspections and technologies that can advance the management of TMF and ensure compliance
- Claire Mooney from Quintiles will address the challenges of working with a sponsor and benefits and burdens of using CRO TMF systems versus sponsors
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