In both a paper and electronic TMF environment, massive challenges delay the successful development, management and monitoring of an inspection-ready TMF. Are you looking to:

– Represent a complete TMF and ensure inspector readiness

– Effectively manage internal and external correspondence

– Successfully convert to a cost-effective eTMF system

– Ensure positive CRO oversight that ensures TMF completeness, quality and timely delivery

– Implement an effective change management strategy

In this 100% case study and discussion based event running in Barcelona on the 7th to 9th September, we are joined by keynote speaker, Andy Fisher (MHRA), who will clearly define inspector expectations and the MHRA’s position on TMF completeness. With a purely regulatory focused Q&A, challenge ideas, identify common pitfalls and build on successful strategies to ensure inspector readiness.