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EMA New TMF Guideline

A new TMF guideline on GCP compliance in relation to TMFs was recently published by the European Medicines Agency (EMA). The guideline incorporates previous guidance in the EMA draft reflection paper on TMFs and includes guidance based on industry experience, and in addition further guidance from the latest ICH E6 revision.

This is still a draft for consultation, offering useful additional direction on important topics within the TMF/eTMF industry such as the management of numerous electronic systems and the destruction of original paper documents after digitization.

The draft guideline can be downloaded from the EMA website:

By Gillian Gittens, Phlexglobal

What our customers say about us...

"There are CROs that have the capability to do it, some do have the electronic systems. But there isn’t anybody I know who provides as good a solution as Phlexglobal."
Senior Director in Clinical Operations, top 20 global pharma
"Phlexglobal has experience in handling eTMF documents and has this as its core competency. It makes sense to outsource to them."
Associate Director of MRP Management, US pharma

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