Medical Writing Medical Writing in Paediatrics Regulatory Writing

Volume 21, Issue 2 - Medical Writing in Paediatrics

Regulatory Writing

Abstract

In October 2010, the American congress passed the Physicians Payment Sunshine Act, which will force drug and medical device manufacturers to disclose their payments to healthcare professionals (HCPs). Starting this year, drug makers are required to track all payments to HCPs and from September 2013 onwards, details of these payments will be made freely available on the Internet for all and sundry to analyse. In other countries too, for example the UK with the new Association of the British Pharmaceutical Industry (ABPI) code of practice update, drug companies will be forced into disclosure, though the requirements are usually somewhat less stringent. In response, pharmaceutical companies have been scrambling to become compliant. This is no mean feat, given the complexity and extent of the relationship between drug companies and HCPs. In particular, large drug companies operate in many different countries with many different business cultures and attitudes, and under many different legislative frameworks.

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Articles

Medical writing in paediatrics: Children and the future
Message from the President
Challenges of paediatric drug development and impact of paediatric legislation
Writing applications for Paediatric Investigation Plans and waivers
Preparing the Paediatric Investigation Plan application
ADHD: A true neurodevelopmental disorder?
Medicines information for patients: Insights into research and practice for medical writers
The MHRA perspective on the new pharmacovigilance legislation
Are stem cells the future of healthcare?
O, safety, quo vadis?
Crowdpower in the era of ‘health 2.0’
Networking effectively: Essential for being successful in business
The moving image and your business
Forgive me for repeating myself: Self-plagiarism in the medical literature
In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
Regulatory Writing
English Grammar and Style
Out On Our Own

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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

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

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Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

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

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Morris

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk