Medical Writing Risk Management Regulatory Writing: Review process in regulatory writing
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Volume 24, Issue 2 - Risk Management

Regulatory Writing: Review process in regulatory writing

Abstract

Recently, Phil Leventhal posed the question ‘What does it take to go from being a good medical writer to an excellent one?’ on EMWA's LinkedIn Discussion Group. My impression is that the responses were written largely with medical communications (that is, texts for publication) in mind rather than regulatory writing per se. Posters made plenty of useful suggestions such as a focus on the target audience and forward planning. Given the involved debate about ghost writing, I was perhaps a little surprised though that there was no mention of ensuring that the thoughts and opinions of (all) named authors are included. According to my understanding, medical writers are channels through which the intellectual authors can express themselves appropriately. This presumably involves interacting and negotiating with authors during review rounds to ensure that the text is representative of the desires of the headline authors.

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Articles

Risk Management
President's Message
The changing face of (benefit-)risk management
Pharmacovigilance medical writing: An evolving profession
A shot at demystifying the risk management plan for medical writers
Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?
Special section: Winners of the Geoff Hall Scholarship essay competition
News from the EMA
Profile: An interview with Ingrid Edsman on why attending EMWA conferences is so rewarding!
The Webscout
In the Bookstores
Regulatory Writing: Review process in regulatory writing
Lingua Franca and Beyond
Gained in Translation
Manuscript Writing
English Grammar and Style: Revising medical writing Reasons not rules: Backtracking, pronoun-induced Part 3 - Double syntactic unit revision and syntactic position revision
Out On Our Own

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