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.

21-23 May 2019

& 14-16 Oct 2019

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 course combines lectures 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 seminar 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 & Technical Aspects

  • The Clinical Study Report (CSR): General Aspects*

Punctuation Specifics

  • CSR Templates

Improving Readability – Being Kind to Your Reader

  • Verb force & Tense
  • Paragraphing & Word Order
  • Verbosity
  • Prepositions
  • Abbreviations

CSR: Opening Chapters & Synopsis

  • Investigational Plan
  • Results – Efficacy

More on Improving Readability Results – Safety

Programme Day Two

CSR – Post-scripts: 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

Writing the Investigator’s Brochure

  • ICH E6 guidance
  • Organising multiple author contributions
  • Project management
  • Consistency within and between topics

Abstracts

Programme Day Three

09.00 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

  • 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 versus time

Final Checks – Proofreading

Writing Tips & Tools

Working with Co-authors & Reviewers

Presenters

Barry Drees (21-23 May 2019)

1976 – 1980 B. A. in Molecular Biology at the University of California, Santa Barbara, USA
1980 – 1986 Ph.D. in Genetics at University of California, San Francisco, USA
1986 – 1989 Research fellow of the American Cancer Society, at the “Biochemischen Institut der Universität Freiburg“
1989 – 2001 Medical Writer in Hoechst AG, (later HMR, Aventis)
1992 Appearance in German television: SWF 3 “Schau rein, Schulfernsehen – Gentechnologie”
1994 Certified as “Editor in the Life Sciences (ELS)”
1995 – 1999 Ombudsman for Clinical Operations, HMR
1996 Vice-president European Medical Writers Association (EMWA)
1996 Manager, Medical Writing Phase I – IIa
1997 President European Medical Writers Association (EMWA)
1998-2004 Editor-in-chief of “The Write Stuff, The Journal of the European Medical Writers Association”
2002 Deputy Director Medical Writing, Covidence GmbH
2002 Managing Director, Trilogy Writing GmbH
Since 2011 Senior Partner, Trilogy Writing GmbH

Barbara Grossman (21-23 May 2019)

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 2018 is EMWA’s Vice‑President. In addition, she is an Associate Editor of Medical Writing, EMWA’s journal.

James Visanji (21-23 May 2019)

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

21-23 May 2019
21-23 May 2019 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now
14-16 Oct 2019
14-16 Oct 2019 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now

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  • Bayer Healthcare
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  • Celgene GmbH
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  • Leo Pharma A/S
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  • Q-Med AB
  • SCHERING OY
  • Sheffield University
  • Terumo BCT
  • Teva Pharmaceutical Industries Ltd
  • University of Copenhagen
  • XPE Group NV
  • Zentiva ks

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.

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

The course met all of my expectations

Fida Issa, Safety Specialist, H. Lundbeck A/S

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

Emma Biggs, Clinical Research Scientist, GlaxoSmithKline

Great speakers with a very deep knowledge on the subject

Jone Iriondo, Medical Writer, Insitut Bergonié

All great speakers, very knowledgable

Mike Mueller, Medical Writer, Scinopsis Ltd

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

Professional, interesting and relevant

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

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

Karin Jackson, Regulatory Coordinator, Hansa Medical AB

Inspiring yet realistic

Ghazaleh Karimi, Drug Safety Manager, AbbVie

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

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

Agathe Caruso-Vares, , CEVA Sante Animale

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

Louise Harkness, Medical Writing Scientist, GlaxoSmithKline

An informative course with entertaining sessions

Anna LeMoine, Project Leader, Tissue Regenix Ltd

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.

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

Solange Van de Moortele, Clinical Project Manager, Wright

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