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Glossary

Early Dialogues Working Party (EDWP)

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The Early Dialogues Working Party (EDWP) is a standing committee established by EUnetHTA to ensure robust high-quality HTA outputs. All EDWP members will participate in procedures selected for Consolidated Parallel Consultation.

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I

ISO 13485

ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and…

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e

eTMF/ TMF: electronic Trial Master File / Trial Master File

Electronic or paper filing system which must contains all study documents and at least essential…

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