Medical Writing Careers in medical writing Regulatory Public Disclosure

Volume 28, Issue 1 - Careers in medical writing

Regulatory Public Disclosure

Abstract

EMA published their first report on the Policy 0070 publication of clinical data ( July 16, 2018): https://www.ema.europa.eu/documents/report /clinical-data-publication-policy-0070-reportoct- 2016-oct-2017_en.pdf. Over the period October 2016 to October 2017, EMA’s report provides information on the total number of docu ments published, the amount of commerc - ially confidential information (CCI) redacted and the anonymisation techniques used.

Download the full article

References

  1. RPD SIG members’ page Available from: https://www.emwa.org/members/ special-interest-groups/regulatorypublic- disclosure-sig/
  2. “Anonymizing Health Data: Case Studies and Methods to Get You Started” by Khaled El Emam and Luk Arbuckle, ISBN number 978- 1-449-36307-9, is available as an eBook. Précis: “Updated as of August 2014, this practical book will demonstrate proven methods for anonymizing health data to help your organization share meaningful datasets, without exposing patient identity. Leading experts Khaled El Emam and Luk Arbuckle walk you through a risk-based methodology, using case studies from their efforts to de-identify hundreds of datasets.”
  3. “Guide to the De-identification of Personal Health Information” by Khaled El Emam, ISBN number 978-1-4665-7906-4, is available as an eBook. Précis: “Offering compelling practical and legal reasons why de-identification should be one of the main approaches to protecting patients’ privacy, the Guide to the De- Identification of Personal Health Information outlines a proven, riskbased methodology for the deidentification of sensitive health information. It situates and contextualizes this risk-based methodology and provides a general overview of its steps.”

Search

Articles

Careers in medical writing
President’s Message
EMWA News
How to get your first job as a medical writer
Educating the medical writer: A 5-year update
Cheeky medical writers: Transitioning from academia to medical writing
Making the leap: My move from academia to medical writing
From bench to pen: Life as a new medical writer
The grass is always greener on the other side
Pharmaceutical writer or CRO writer – choosing the right path
Career shift: Employment to freelancing
Medical writing and medical translation – two crossing paths
Career opportunities in medical device writing: Employee and freelance perspectives
Career shifts – surviving a change in geography
Grant writing and editing
1000 words in 1 picture
Medical writing at the management level
Thriving (and not just surviving) in a VUCA healthcare industry
Elevate your medical writing team to success
Clinical trial disclosure landscape and awareness in Japan
News from the EMA
Regulatory Matters
Gained in Translation
In the Bookstores
Medical Devices
Journal Watch
Veterinary Medical Writing
Good Writing Practice
Medical Communication
Regulatory Public Disclosure
Out on Our Own
Vignettes - Life After Medical Writing

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk