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Successful Medical Writing Training Course: face to face & live webinar

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.

5-7 Oct 2020

& 24-26 May 2021 , 4-6 Oct 2021

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 a positive outcome. This intensive three-day medical writing course will help you to improve your skills and achieve this standard.

Aims and objectives

This event combines presentations from our expert faculty 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.

You 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?

The 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, 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 1

Overview of writing: substantive and technical aspects

Improving readability – being kind to your reader

  • Punctuation specifics
  • Verb force and tense

The CSR

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

More on the CSR and improving readability

Programme - day 2

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

Writing the investigator’s brochure

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

Programme - day 3

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

Presenters

Barry Drees (More...)

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 (More...)

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 (More...)

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 Medical Writing 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

  attend Face to face attend Live webinar
5-7 Oct 2020, Rembrandt Hotel, London
5-7 Oct 2020 Rembrandt Hotel, London GBP 1,549.00
EUR 2,169.00
USD 2,416.00
Until 24 Aug*
Enrol now
to attend
Face to face
GBP 1,249.00
EUR 1,809.00
USD 2,056.00
Until 24 Aug*
Enrol now
to attend
Live webinar
24-26 May 2021, Venue not yet confirmed
24-26 May 2021 Venue not yet confirmed GBP 1,549.00
EUR 2,169.00
USD 2,416.00
Until 12 Apr 21*
Enrol now
to attend
Face to face
GBP 1,249.00
EUR 1,809.00
USD 2,056.00
Until 12 Apr 21*
Enrol now
to attend
Live webinar
4-6 Oct 2021, Venue not yet confirmed
4-6 Oct 2021 Venue not yet confirmed GBP 1,549.00
EUR 2,169.00
USD 2,416.00
Until 23 Aug 21*
Enrol now
to attend
Face to face
GBP 1,249.00
EUR 1,809.00
USD 2,056.00
Until 23 Aug 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • 3X Consultants
  • Acino International AG
  • Actelion Pharmaceutical Ltd
  • Actelion Pharmaceuticals Ltd
  • Albihns Malmo AN
  • AMERSHAM HEALTH
  • BAUSCH & LOMB INC
  • Chiesi Espana
  • Chiesi Farmaceutici S.p.A.
  • EGIS Pharmaceuticals PLC
  • Ferring Pharmaceuticals A/S
  • Galderma R&D
  • Genzyme Europe BV
  • GlaxoSmithKline Consumer Healthcare
  • Idorsia Pharmaceuticals Ltd
  • Ismar Healthcare
  • Janssen Biologics B.V.
  • Janssen Biologics BV
  • Keyrus
  • Leo Pharma A/S
  • Medfiles Ltd
  • PHARMACEUTICAL RESEARCH ASSOCIATES
  • Q-Med AB
  • RB
  • RICHMOND PHARMACOLOGY LTD
  • Terumo BCT
  • TRIAL FORM SUPPORT AB
  • Unomedical a/s - A Convatec Company
  • Vetcare Oy
  • Zentiva Group AS

I love this course and have recommended it to my colleagues.

Nisha Patel, Clinical Research Principal Scientist, GlaxoSmith Kline, Oct 19

Each speaker was very inspiring.

Natasa Fischbach Simunic, Medical /Pharmacovigilance Advisor, Xellia d.o.o., Oct 19

Absolutely perfect. I was personally looking for a change in my career and medical writing is definitely my first choice. The presentations were very interactive and fun!

Bouchta Karrich, Scientific Information Officer, Laboratoires THEA, Oct 19

The content is highly relevant for new medical writers and the speakers are engaging. I would recommend it for anyone entering the profession.

Maria Dzialo, Medical Writer, Data Investigation Company Europe, Oct 19

The content of the talks was appropriate and useful, the topics were clearly presented and the practical exercises helped to learn efficiently.

Katrin Vögtlin, Manager Clinical Affairs, Richard Wolf GmbH, Oct 19

It surpassed my expectations in every way.

Vasco Cluny, Freelancer Science/Medical Writer, Built by Doctors, May 19

I was very happy with the course. 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, May 19

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, May 19

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

Marga Paterson, Senior Medical Writer, Vennlife Sciences EDS, May 19

Really great course with very useful content and excellent speakers.

Janne Walmod, Medical Communication Specialist, Cook Medical, May 19

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, May 19

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 and 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), May 19

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, Oct 18

The training was of good quality and the speakers succeeded in making it dynamic and practical. It will be very helpful for my future work.

Adeline Pierre, Medical Manager, Bayer Consumer Care, Oct 18

Great course, I learned a lot.

Danielle Rieks, Regulatory Affairs Officer, Beaphar B.V., Oct 18