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
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
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.
Overview of writing: substantive and technical aspects
Improving readability – being kind to your reader
Paragraphing and word order
The Clinical Study Report (CSR)
More on the CSR and improving readability
CSR – postscripts: after the main text
Statistics for medical writers
The Common Technical Document
Writing publications, including abstracts
Advanced data presentation
Just how perfect does your document have to be?
Final checks – proofreading Writing tips and tools
Working with co-authors and reviewers
General discussion and end of course
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 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.
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.