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Going from Pharma to Medical Devices

Level:
Foundation
Area:
Medical Devices
Code:
MDF2a
Duration:
03:30:00
Workshop profile:
This workshop is primarily intended for medical writers who have some knowledge of regulatory guidance and are interested in working with medical devices. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.
Objective:
The aim of this workshop is to understand the EU regulatory pathways, to become familiar with the documents used for medical devices to see these in the light of those used for pharma, and to identify transferable medical writing skills between pharma and medical devices.
Content:
The workshop will compare and contrast Pharma vs Medical Devices with respect to · definition of terms · product development steps · EU regulatory pathways, guidelines and requirements · documents · medical writing transferrable skills