Medical Writing Post-Approval Regulatory Writing Post-approval regulatory writing – How different is it from writing pre-approval documents?

Volume 23, Issue 4 - Post-Approval Regulatory Writing

Post-approval regulatory writing – How different is it from writing pre-approval documents?

Abstract

Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information presented to the regulators. Submission package should comply with the required guidelines and report structure. In addition, they should be written in a style that allows regulators easy access to the safety and efficacy information needed for making a decision on marketing the drug. Post-approval writing can present some interesting situations and challenges to the sponsor and the medical writer. It is important for a medical writer to be aware of these situations and make the necessary plans to surpass them, working with experts in different domains to ensure timely availability of the right drug to the right patients. The article describes in detail some of these situations.

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References

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  2. European Medicines Agency. Dossier format: regulatory and procedural guidance [Internet]. [cited 2014 Aug 6]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000102.jsp&mid=WC0b01ac058002c599
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Articles

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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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Raquel Billiones

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Evguenia Alechine

Jonathan Pitt

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Victoria White

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Alicia Waltman

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Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

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Somsuvro Basu

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Aurélie Gobet / Paolo Rega

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Raquel Billiones

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Wendy Kingdom / Amy Whereat

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Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

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Lisa Chamberlain-James

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Namrata Upadhyay

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Evguenia Alechine

My First Medical Writing

Anuradha Alahari

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Laura Kehoe

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Jennifer Clemens

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Sam Hamilton

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Claire Gudex

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Kimi Uegaki

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Karim Montasser

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Elise Langdon-Neuner

Phil Leventhal

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Chris Monk