Medical Writing Post-Approval Regulatory Writing Out On Our Own
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Volume 23, Issue 4 - Post-Approval Regulatory Writing

Out On Our Own

Abstract

In these dark winter months, how many of us have day-dreamed about moving to an exotic, sunny location? Janet Davies describes how she did exactly that when she resigned from her job in Holland and moved to the Azores to start a new life as a freelancer. Alistair Reeves and Suzanne Geercken provide more useful language resources for non-native speakers in the final part of their series, which has filled our bookshelves with many helpful references.

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Articles

Post-approval regulatory writing
President's Message
Responding to concerns over the PSMF: Inspectors offer key insights
Post-approval regulatory writing – How different is it from writing pre-approval documents?
Strategic medical writing in the post-authorisation phase
Non-interventional Post-Authorisation Safety Studies (NI-PASS): A different type of report
Writing publications for advisory boards
The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance
Profile: An interview with Esther Moreno Barriuso: On some fundamental concerns of medical interpreting
English Grammar and Style
News from the EMA
The Webscout
In the Bookstores
Out On Our Own
The Light Stuff

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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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