Management Forum courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

Successful Medical Writing Training Course

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.

11-13 Jul 2022

& 11-13 Oct 2022

Book now

Details

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

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

Statistics for medical writers

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

CSR – postscripts: after the main text

Quality control

Designing tables

  • Table types
  • Elements of table design

More on the CSR and improving readability

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

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 was EMWA's President for 1 year until May 2020. In addition, she is an Associate Editor of Medical Writing, EMWA’s journal.

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.

James Visanji (More...)

James holds a PhD in Medicine from the University of Manchester, Masters in Clinical Genetics from the University of Sheffield, Chartered Linguist status from the Chartered Institute of Linguists, and the European Medical Writers Association Nick Thompson Fellowship.

After postdoctoral work at Istituto Europeo di Oncologia, James started his medical writing career in 2006. Based in Frankfurt, he is currently Associate Director of Regulatory Services at Synchrogenix, and was previously Medical Writing Manager at Trilogy Writing, and Deputy Director of Medical Writing and Electronic Publishing at Accovion.

James focuses on clinical and regulatory documentation, in particular, submission dossiers and subsequent regulatory interactions. James has been training medical writers and physicians since 2012, and claims to get his biggest buzz from making the next generation of writers as effective as possible, as quickly as possible.

Book now

Book now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
11-13 Jul 2022
Live webinar
09:15-17:30
UK (London)
11-13 Jul 2022
Live webinar
09:15-17:30
UK (London)
GBP 1,549.00
EUR 2,229.00
USD 2,524.00
+ VAT @ 20.00%
Enrol now
to attend
Live webinar
11-13 Oct 2022
Live webinar
11-13 Oct 2022
Live webinar
GBP 1,549 1,249
EUR 2,229 1,809
USD 2,524 2,056
Until 6 Sep*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 18 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

You may also be interested in

Previous customers include...

  • ALK
  • Alkaloid AD Skopje
  • Almirall S.A.
  • Baxter Innovations GmbH
  • Biotop Medical
  • Bracco Imaging SpA
  • Celgene International Sarl
  • CEVA Sante Animale
  • Debioclinic SA
  • Dr Anny-Odile Colson
  • Galderma R&D
  • Gilead Sciences
  • Glycorex Transplantation AB
  • Grindeks JSC
  • Guidant Europe NV
  • GW Pharmaceuticals
  • HAL Allergy BV Leiden
  • Idorsia Pharmaceuticals Ltd
  • Independent Clinical Research Consulting
  • JOHN PAUL II HOSPITAL
  • Kyowa Hakko Kirin UK Limited
  • McDonough Clinical Research Ltd
  • medac GmbH
  • Mercury Pharmaceuticals Ltd
  • MRN
  • Pfizer Ltd
  • ProductLife Limited
  • Sintetica SA
  • Stiefel Labs (UK) Limited
  • Zentiva ks

I wanted to get some hints and tips on general improvements in writing style when compiling regulatory dossiers - and interested to know more about the required content in the clinical section of the eCTD, which I believe was delivered.

Judith Rowland, Senior Regulatory Affairs Manager, Nerudia Limited, May 21

Good, engaging and knowledgeable speakers.

Marit Sorum, Regulatory Affairs Manager, Pharmaq, May 21

I was really satisfied with the webinar. It reflected my expectations and it addressed my needs.

Roberta Grimaldi, Clinical research principal scientist, GSK, May 21

I got what I hoped for - i.e. an introduction to the types of documents I will come across, how to select the right content, and how to write it. On top of this, it was extremely useful for me to receive all the little tips and tricks. I think all presenters were very generous in sharing their experience. This includes how to manage difficult stakeholders, when to stick to guidelines and when to use common sense, where to find links on correct use of English, and even be able to ask questions in the future on how to present data.

Lone Helboe, May 21

A fantastic training, a "must-do".
The training via live webinar is working very well, less resource-demanding (time and costs).

Tifany Desprez, Medical Writer, PhD, Laboratoires THEA, Oct 20

Overall, very interesting and enjoyable.

Tyrnnon Steffen, Medical Writer, DICE-CRO, Oct 20

What a wonderful training course, especially for medical writers beginning their career. So much information is packed in this webinar and is presented in a very professional and entertaining way. Warmly recommended.

Cristiane Jensen, Senior Electronic Submissions Coordinator, H. Lundbeck A/S, Oct 20

The interactive exercises and polls were very useful, in the future you could include more of these.

Julia Peics, Medical Writer, ALK, Oct 20

This webinar had a broad array of topics and was delivered in a very interesting manner. The courses were nicely illustrated by a large number of examples and exercises. The speakers managed to deliver their messages efficiently, involving and keeping the interest of the audience along the 3 days.

Ophelie Poujade, Regulatory Affairs Specialist, Alexion Pharma GmbH, Oct 20

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

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

Nisha Patel, Clinical Research Principal Scientist, GlaxoSmith Kline, 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

Each speaker was very inspiring.

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

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