Medical Writing Good Pharma Regulatory Writing

Volume 22, Issue 4 - Good Pharma

Regulatory Writing

Abstract

The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports included in a common technical document submission, along with the accompanying summary documents and overview. The varied stakeholders (pharmaceutical companies, patients) will have different opinions on the draft. The European Federation of Pharmaceutical Industries and Associations, a major representative of the pharmaceutical industry, have been particularly critical. While greater transparency is to be welcomed, inappropriate analyses of the data causing unwarranted public alarm and identification of anonymised information remain major concerns.

References

  1. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. Trials 2010;11:9. Available from: http://dx.doi.org/10.1186/1745-6215-11-9
  2. Steinbrook R. The European Medicines Agency and the brave new world of access to clinical trial data. JAMA Intern Med 2013;173(5):373–4. Available from: http://dx.doi.org/10.1001/jamainternmed.2013.3842

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Message from the President
Transparency and the healthcare industry: The Sun is shining
Sunshine spreading across the Atlantic and over Europe
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If a misinformed voice speaks out in the wilderness and no one refutes it, does it make a sound? A call to advocacy
The Big Pharma conspiracy theory
Editorial: Pharmaism
Legal remedies for medical ghostwriting: Imposing fraud liability on guest authors of ghostwritten articles
A decade of change: A new ISMPP has arrived
Selling evidence over the counter: Do community pharmacists engage with evidence-based medicine?
Good regulatory practice and the role(s) of a regulatory affairs professional
Profile: An interview with Dr Gustavo A. Silva on the concept of public health in medical writing and translation
AuthorAID: An international service and chance to serve
India as a hub for ethical and evidence-based medical communications
Providing value for medicines in older people
In the Bookstores
Journal Watch
The Webscout
Regulatory Writing
Medical Communications
Manuscript Writing
Out On Our Own
Erratum
The Light Stuff

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk