Medical Writing Regulatory Writing Basics Message from the President

Volume 23, Issue 2 - Regulatory Writing Basics

Message from the President

These two years in the Executive Committee flew by. They will remain in my heart for ever. It is difficult to summarise the emotions and the things we accomplished these last two years. When this adventure started in Cyprus, Susan Bhatti, the previous EMWA President, and me met to discuss EMWA's situation and its objectives. We realised that EMWA is an excellent organisation with a great reputation and a clear strategy for its development, thanks to our previous presidents and Executive Committees.

Because we met most of our objectives we have a bright future. Thanks to excellent work by the Executive Committee and Head Office, we have improved the branding of EMWA, renewed the website, installed a new voting system, carried out several surveys, revised bank and insurance agreements, improved the productivity of Executive Committee meetings by adding winter and summer face-to-face meetings, increased the distribution of the journal, and added member benefits by building agreements with software vendors and other professional associations. By adding new sponsors, more members, and greater attendance at conferences, we have been able to maintain the annual fee and to offer discounts for those referring new EMWA members. This healthy situation, together with the great work of the Head Office, have also allowed us to begin planning conferences all the way until 2017, to create e-learning modules, and to put into place a new 3-year plan. Our collaborations with the European Medicines Agency and other professional associations show that EMWA is clearly a reference organisation for medical writing in Europe.

I will conclude by saying that governing the wonderful Executive Committee and Head Office has been a great pleasure. They have worked hard, but always with a smile, to make all of this happen.

I am more than confident that the new Executive Committee will continue the initiatives to better serve our members and the organisation and that Julia will be a great president!

I look forward to meeting you all in Florence.


Thank you, Andrea, for guiding me through the past year on the Executive Committee and for preparing me for the role of President.

First, a little about my background and what I bring to the position of EMWA President. I am a PhD pharmacist who has worked in the pharmaceutical industry and medical communications for 25 years (how scary is that?). For the last 10 of these years, I have been freelance and have enjoyed a good work-life balance as a medical writer, stand-in editorial director, and out-contracted publication manager.

I have been a member of EMWA for 15 years and gave my first workshop in 1999. Although I spent several years on the EMWA Professional Development Committee, my last year on the Executive Committee has been a true education on the complexity of the organisation and the dedication and commitment of our Head Office and my fellow committee members.

EMWA is already a successful organisation as evidenced by our recent spring conference in Budapest, which included an excellent symposium on transparency, comprehensive educational programme, and smooth logistics. We also have the impressive new website, a highly regarded journal and, of course, our growing public relations offerings. As the new President, I want to build on this success by supporting membership growth, expanding our association into e-learning and new media, and promoting links with other professional organisations. I am keen to ensure that EMWA can meet the needs of the membership now and in the future. I have already presented the vision for EMWA over the next three years and am currently working on the key areas and action points.

Our autumn conference this year will be in Florence (Andrea's home town!) – a fantastic opportunity to combine a beautiful and cultural setting with education, networking, and fun. I look forward to meeting even more of you there, but if you do want to get in touch before November, I would be delighted to hear from you.

Julia Donnelly

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Regulatory writing basics
Message from the President
A guide to pre-approval regulatory documents
Effective authoring of clinical study reports: A companion guide
The clinical study protocol and medical writing: A good fit?
The Investigator's Brochure: A multidisciplinary document
An overview of the Common Technical Document (CTD) regulatory dossier
Good clinical practice (GCP): A universal call for ethics in biomedical research
Adverse event reporting: A brief overview of MedDRA
The approval process of medicines in Europe
Recommended procedures for retracting articles: Inadequate and patchily applied? Analysis of a recent article in PLoS One
The needs assessment in continuing medical education
Origin and development of English for Medical Purposes. Part II: Research on spoken medical English
Did minor flaws in a new drug reveal major flaws in company publication practices?
What every medical writer needs to know
Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy
In the Bookstores
Journal Watch: Dedicated medical writing rotation for pharmacists, publication of drug industry funded research, and evidence-based medicine for clinical decision making
Regulatory Writing: The essence of regulatory writing as defined by its jargon
Medical Communication
News from the EMA
English Grammar and Style: Points of view
The Webscout
Gained in Translation: Science at the multilingual crossroads
Out On Our Own
The Light Stuff


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

Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Brooks Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


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


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


Tiziana von Bruchhausen


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