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Going from Pharma to Medical Devices

Level:
Foundation
Area:
Medical Devices
Code:
MDF2
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 skills between pharma and medical devices.
Content:
The workshop will explain the following: · Definition of Terms: Pharma vs Medical Devices; · The EU Regulatory Pathway: Pharma vs Medical Devices; o Product development steps; o Regulations and guidelines; · The Documents: Pharma vs Medical Devices; · Transferable Skills; · Case Studies.