Successful Medical Writing

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals and the quality of documentation submitted to the regulatory authorities. This intensive practical medical writing course will benefit participants by enabling them to achieve this standard.

18-20 May 2020

& 5-7 Oct 2020

GBP 1,849
EUR 2,589
USD 2,884

Book now

Course overview

Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring success. This intensive practical medical writing course will benefit participants by enabling them to achieve this standard.

Aims and objectives

This intensive and interactive event combines presentations with practical exercises to provide a thorough introduction to the basics of medical writing that goes beyond the usual ‘overview’ courses. It will provide in-depth training in general writing and data presentation skills, and specifically in the kind of documents most frequently encountered in clinical research. Participants will learn both the theoretical and practical aspects of writing for regulatory authorities as well as the sensible use of international guidelines, standards and useful writing tips. Many illustrative examples will be used, drawn from the course leaders’ wide experience of the pharmaceutical industry

Who should attend

This three-day course will be of interest to all those in the pharmaceutical industry who prepare research reports and documentation intended for regulatory authorities. Although the focus of the seminar is on clinical research documentation, many of the principles will also apply to other types of reports, including pre-clinical, CMC and veterinary documentation. The practical training will benefit not only those new to medical writing, but also those wishing to perfect their existing writing skills, including full-time medical writers and those who only occasionally write research documentation or regulatory submissions.

Programme day one

Overview of writing: substantive and technical aspects

Improving readability – being kind to your reader

  • Punctuation specifics
  • Verb force and tense

Paragraphing and word order

  • Verbosity
  • Prepositions
  • Abbreviations
  • Text review, edit or rewrite

The Clinical Study Report (CSR)

  • General aspects
  • CSR templates
  • Opening chapters and synopsis
  • Investigational plan
  • Results – efficacy
  • Results – safety

More on the CSR and improving readability

Programme day two

CSR – postscripts: after the main text

Quality control

Designing tables

  • Table types
  • Elements of table design

Statistics for medical writers

  • Statistical basis of clinical studies
  • Misuse of p-values
  • Primary vs secondary efficacy variables
  • Developing confidence in confidence intervals

Programme day three

The Common Technical Document

  • Introduction to clinical submission dossiers
  • Purpose and types of clinical summary documents
  • Writing the clinical overview and the clinical summary
  • Recent regulatory developments: really a common technical document?

Writing publications, including abstracts

  • Publications vs clinical study reports
  • Consort guidelines for reporting randomised controlled clinical trials
  • Maximising acceptance
  • Understanding instructions to authors

Advanced data presentation

  • Graphs, plots, charts and diagrams
  • Design and use of flowcharts

Just how perfect does your document have to be?

  • How important is ‘perfect’ grammar?
  • Suiting language to the audience
  • Is word order really important?
  • Quality vs time

Final checks – proofreading Writing tips and tools

Working with co-authors and reviewers

General discussion and end of course

Presenters

Barry Drees

Dr Barry Drees has a PhD in molecular biology and he is an experienced trainer of medical writers today. He graduated from the University of California Santa Barbara and the University of California San Francisco (USA), was president of the European Medical Writers Association, was editor-in-chief of the Journal of the European Medical Writers Association, and has been a Senior Medical Writer since 1989.

Barbara Grossman

Barbara Grossman has a passion for proofreading, quality control, and education. She is a biochemist by training and a medical writer, editor and teacher by profession, with 20+ years’ experience in the pharmaceutical industry. Before starting her own medical writing and consultancy business (Hawkeye Medical Limited), she built up and managed the medical writing group at Covance, the contract research organisation, working in a wide range of therapeutic areas. She has given professional development training at educational institutions and organisations such as the DIA (Drug Information Association – Europe and USA), EMWA (European Medical Writers Association) and NICE (National Institute for Health and Care Excellence), and has led many company-internal training courses. Barbara is an honorary member of EMWA, was Treasurer 1998–2005, has been an EMWA workshop leader since 2001, served on EMWA’s Education Committee 2010–2018, was the Education Officer for 2 years until 2016, and since May 2019 is EMWA’s President. In addition, she is an Associate Editor of Medical Writing, EMWA’s journal.

James Visanji

Dr James Visanji PhD MCIL works at Trilogy Writing & Consulting GmbH. James is a trained medical scientist and linguist. He has postdoctoral research experience in oncology and cell biology at the University of Manchester and European Institute of Oncology (Milan), following which he worked as a freelance translator, before discovering medical writing in 2006.
In 2013, James moved from Deputy Director of Medical Writing at Accovion (Clinipace) to become a manager at Trilogy Writing & Consulting, in Frankfurt. James focuses on regulatory and clinical documentation, in particular submission dossiers, study protocols, and reports. In addition James provides training in regulatory writing and medical communications to clients worldwide.
James has been an EMWA workshop leader since 2012, and treasurer since 2013.

Book now

18-20 May 2020
18-20 May 2020 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now
5-7 Oct 2020
5-7 Oct 2020 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

You may also be interested in

Previous customers include...

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • ALK
  • AMGEN LTD
  • ARCOMED
  • Baxter Healthcare Ltd
  • Biotest AG
  • British Technology Group
  • CYTOS Biotechnology AG
  • Evrokontakt Plus
  • Fresenius Kabi AB
  • Fujirebio-Europe NV
  • Glaxo Smithkline Biologicals
  • Grunenthal GmbH
  • H. LUNDBECK AS
  • LINK MEDICAL RESEARCH AS
  • Medicines and Medical Devices Agency of Serbia
  • Merial SAS
  • Molnlycke Healthcare AB
  • Novartis Vaccines & Diagnostics SRL
  • OCT Group
  • Octapharma Pharmazeutika Prod.Ges.m.b.H.
  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Orion Corporation Orion Pharma
  • Pfizer Limited
  • PHYTOPHARM PLC
  • RICHARD WOLF GmbH
  • SGS Belgium NV Life Science Services
  • TRIAL FORM SUPPORT AB
  • UCB Pharma SA
  • University of Surrey

The course was very informative and provided ample guidance on how to approach writing various documents. I found the examples and exercises very useful. The presenters were very engaging. The course met all my expectations.

Anuradha Marla, Medical Writer, LEO Pharma A/S

It surpassed my expectations in every way.

Vasco Cluny, Freelancer Science/Medical Writer, Built by Doctors

Really great course with very useful content and excellent speakers.

Janne Walmod, Medical Communication Specialist, Cook Medical

I really liked the course overall. The content was new and exciting and the speakers and presentations high quality.

Stine Spray, Specialist, Medical Communication, Regulatory Affairs, William Cook Europe

The intensive course gave a comprehensive overview on the topic of medical writing. Each of the lecturers were interesting, dynamic and very professional, with a good sense for humour also. You can gain a new perspective on the differences of various European languages and on the way the English language has developed throughout the years, and can also pick-up various tips&tricks to become a successful medical writer.

Maja Culjak, Associate for Medicinal Product Information Review, Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

I have enjoyed this course very much. It was a nice atmosphere. The content of the course was overall good. The presentations were helpful and the speakers were nice and have a good knowledge of the topics.

Marga Paterson, Senior Medical Writer, Vennlife Sciences EDS

I was very happy with the course and terms of all three parameters. For me with 2 years of experience interpreting clinical data but no MW experience it was the exact level I needed. I got a lot of new information but i felt like I could still follow everything.

Thea Christensen, Medical Writer , ALK-Abelló

The training was of good quality. The speakers succeeded to make it dynamic and practical while it's not easy for this type of content. Good rhythm (exchange of speakers, breaks etc.). It will be very helpful for my future work.

Adeline Pierre, Medical Manager, Bayer Consumer Care

Speakers were highly engaging. Content and presentation were straight to the point with useful examples/exercises. This course was very helpful.

Elsa Sirou, Regulatory Affairs Specialist, Alexion Pharma GmbH

Great course, I learned a lot.

Danielle Rieks, Regulatory Affairs Officer, Beaphar B.V.

The course met all of my expectations

Fida Issa, Safety Specialist, Lundbeck

Really well organised sessions, good break up of topics. Excellent course!

Emma Biggs, Clinical Research Scientist, GlaxoSmithKline

Very good, knowledgable, clear, supportive of medical writers and the battle they have with clients.

Ruth Forster, Post Marketing Project Manager/Medical Writer, ProductLife

I attended previously EMWA workshops where the speakers had presented - so I knew previously that they are good! The course was vey good, interesting topics and good interaction between attendees and presenters.

Helen Thorne, Medical Writer , Tillotts Pharma AG

All great speakers, very knowledgable

Mike Mueller, Medical Writer, Scinopsis Ltd

Great speakers with a very deep knowledge on the subject

Jone Iriondo, Medical Writer, Insitut Bergonié

A really excellent course that has given me a lot more confidence in my job

Karin Jackson, Regulatory Coordinator, Hansa Medical AB

The workshops were very comprehensive and I'm glad there was time for group exercises, which added great value to our discussions/learning

Joana Fernandes, Medical Writer, Scinopsis Ltd

Inspiring yet realistic

Ghazaleh Karimi, Drug Safety Manager, AbbVie

Professional, interesting and relevant

Birgitte Sonne Rasmussen, GCP-Coordinator, GCP-Unit, Denmark

Very good quality content and presentations. I am pleased and satisfied by this course

Louise Harkness, Medical Writing Scientist, GlaxoSmithKline

The course provided a good overview of the medical writing, I liked the way that the information was split among the three days and the speakers were really good

Soteroulla Ioannou, Medical Information Specialist, Janssen Biologics B.V.

Adequate content. Interesting presentation. Dynamic, clear, competent and experienced speakers.

Agathe Caruso-Vares, CEVA Sante Animale

Content is good for newbies like me but it seems that other participants that are working in the area benefited. The presentations are easy to follow and right on point. Barbara, James, and Barry are inspiring.

Bettina Overgaard, Bettina Overgaard

An informative course with entertaining sessions

Anna LeMoine, Project Leader, Tissue Regenix Ltd

Very useful on a daily basis, long lasting learning, lively speakers and presentations

Solange Van de Moortele, Clinical Project Manager, Wright

Was excellent, interactive, and the exercises were very useful to apply what was learnt in the course

Jane Holland, Scientific Writer, Ganymed Pharmaceuticals AG

Very long and intensive days, more shorter breaks would be nice. The course material was not always easy to navigate in.

Vibeke Kildegaard Knudsen, Senior Medical Writer, Novo Nordisk