Tuesday | Wednesday | Friday | Social | Overview

Thursday 10 May Morning Workshop 13:Strategies for Improving Document Quality Workshop 14: Medical Writing and Drug Safety Workshop 15: Maximising Presentation Performance Workshop 16: Syntax, Meaning and Word Order Buffet lunch: Eat & Think - roundtable discussions Afternoon Workshop 17. Ethics for Biomedical Writers and Editors Workshop 18. The Clinical Expert Report Workshop 19. Data Presentation I Workshop 20. European Regulatory Procedures for Medical Writers Evening: See social programme
	09.30 WORKSHOPS
Workshop 13:Strategies for Improving Document Quality (Editing/Writing) Art Gertel (iKnowMed) Objective Improving the process of document preparation is critical for medical writers responsible for pharmaceutical registrations. Elements of quality will ultimately have an impact on the reviewability and approvability of the application. Prior to the workshop, participants will assess their current knowledge about building quality into the documents they produce. During the workshop, they will consider strategies and suggestions for ‘re-engineering’ the organisational culture of quality in their workplace. The follow-up assignment will call upon the participants to report on any success they may have had in changing the dynamicsof document preparation. Workshop content Discussion will include mechanisms to enhance quality and accountability and to ensure adequate time allowances. A medical writing group can build communication policies around organisational issues. These may lead to a higher level of quality consciousness among those with whom they work and upon whose input they depend. Both paper and paperless documentation will be discussed. Participant profile Appropriate registrants would include medical writers, particularly those who work within, or for, pharmaceutical companies. Participants should have at least 1 year’s experience working within a matrix environment and have had responsibility for the preparation of component documents for registration dossiers. Homework Pre-workshop assignment: approximately 2 hours Post-workshop assignment: approximately 2 hours
Workshop 14: Medical Writing and Drug Safety (Pharmaceutical) Mike Matthews (Icon Clinical Research) Objective Writing a clinical trial report often means facing up to an enormous volume of safety data. This workshop is intended to help writers understand how and why so much safety data are generated, and acquire strategies for identifying and reporting the key data without overlooking anything potentially important. Workshop content A comprehensive presentation will be coupled with pre- and post-course assignments using actual (anonymised) safety data from a clinical trial analysis: adverse events, serious adverse events and reactions, laboratory safety data. The emphasis will be on the medical writer’s point of view. Participant profile Medical writers with some experience of writing clinical trial reports who wish to gain confidence in their approach to safety data. No prerequisite EMWA workshops Homework Pre-workshop assignment: 2 hours Post-workshop assignment: immediately before the meeting participants will be sent (preferably by e-mail) a set of safety analyses (some 500 pages). IT IS ESSENTIAL THAT EACH PARTICIPANT PRINTS THIS MATERIAL AND COMES TO THE WORKSHOP WITH A PAPER COPY OF IT. Time needed 2–3 hours
Workshop 15: Maximising Presentation Performance (Foundation) Gerold Wilson (Schering AG) Objective This interactive session, combined with your pre- and post-workshop assignment, will give you the knowledge and confidence to make presentations, brief, and otherwise dazzle audiences. Make no mistake: this is hard work! Mark Twain once said that a 10-minute impromptu talk takes only about 3 weeks of preparation. He exaggerated a bit, but he was still right about the need to plan and prepare. Workshop content The workshop will consist of short lectures on visual aids and presentation techniques and a lot of first-hand experience in presenting materials that you will prepare; in other words, as many participants as possible will deliver short presentations. These will be discussed in the workshop to maximize the learning experience. This will boost your confidence and enable you to apply the lecture information immediately. Participant profile This workshop will be of benefit to all who must present findings or ‘sell’ ideas to groups, especially those with little or no experience in presenting. All participants, even those with a few presentations under the belt will learn to survive – and, in fact, enjoy – presentations of all kinds. There are no prerequisites for this course. Homework Pre-workshop assignment: 3 hours Post-workshop assignment: 2-3 hours
Workshop 16: Syntax, Meaning and Word Order Replacement workshop (Foundation) Alistair Reeves (Aventis) Objective To motivate writers to look more critically at what they and others write in order to improve comprehension and ease of reading, in other words: to be kind to their readers (and themselves!). Structure conveys and affects meaning and should therefore match meaning. The audience addressed must also be taken into consideration. Workshop content The workshop will present basic concepts of sentence construction and word order with the emphasis on written English, and will also explore how other languages can interfere with expected word order in English and disturb the reader. Using good – and bad – examples from everyday medical and pharmaceutical texts, areas such as: Aggregation and separation of ideas Parallelism Verbal nouns and verbs Positioning of modifiers in sentences Paragraph structure Emphasis will be covered. Participant profile From beginners to experts. Homework Pre-workshop assignment: about 1 hour Post-workshop assignment: about 1 hour
12.30 Buffet lunch: Eat & Think - roundtable discussions There will be special ‘topic tables’ in the lunch room, each with a different medical writing theme. The idea is to have roundtable discussions during an extended lunch. This will be an opportunity for delegates to pick out a topic in which they are interested, to share experiences with other writers and to gain new perspectives. Each table will prepare a one-page summary of their discussion, consolidating the general viewpoints, and these summaries will be published in the post-conference issue of The Write Stuff. A sign-up board will be put up ahead of time for you to reserve a seat at the topic table of your choice. Seats will be given on a first-come, first-served basis, so sign up early to be sure to get in on the discussions. 14.30 WORKSHOPS
Workshop 17. Ethics for Biomedical Writers and Editors (Editing/Writing) Faith McLellan (Praxis Press) Objective This workshop will familiarise medical writers and editors with ethical issues and current controversies in biomedical publication. Workshop content In the first third of the workshop, major ethical issues will be reviewed, as well as current analyses of the problems. The pre-course readings will be discussed. The heart of the workshop is small-group work on cases submitted by the participants. After participants have analysed their cases in small groups, the entire group reconvenes to discuss the cases. A few minutes are devoted to the beginning and end of the workshop for introductions, clarifications, and post-workshop assignment instructions. Participant profile Writers and editors involved in any aspect of biomedical publication, loosely construed, are welcome. The issues discussed are generally more familiar to those whose work involves the peer-reviewed literature, but many issues are germane to all aspects of medical writing. Homework Pre-workshop assignment: 3-5 hours Post-workshop assignment: 2 hours
Workshop 18: The Clinical Expert Report (Pharmaceutical) Ben Young (Freelance) Objective Participants will become familiar with the aim and scope of the clinical expert report (CER), and will have the opportunity in the workshop to learn and compare practical approaches to the detailed CER sections. The homework consists of background reading and a written assignment, and the post-workshop exercise consists of a written assignment. Both exercises provide first-hand practical experience. Workshop content During the workshop, interpretations and practical considerations for the detailed sections of the CER are presented and discussed. Participant profile Medical writers with some experience writing clinical documents, not necessarily with previous experience in preparing CERs and dossier submissions. Homework Pre-workshop assignment: 2-4 hours Post-workshop assignment: 3-5 hours
Workshop 19: Data Presentation I (Foundation) Barry Drees (Aventis) Objective At the end of the course participants should be able to: Compose a table or graph when given data in raw form or in paragraph style Recognise the basic parts of a table and a graph and identify the various types of tables and graphs Understand the functions of tables and graphs Identify the strengths and weaknesses in the design of a given table or graph and modify it accordingly Workshop content The role of a medical writer is to be able to present data in the clearest and most understandable form possible. The best way to present and communicate data, however, is not prose but rather by using some form of graphical presentation. This course will challenge and stimulate the participants’ ability to think clearly about the data they present and write about. The aim of this course is to familiarise participants with the basic tools of data presentation, tables and graphs, their types and components, and when - and when NOT - to use them. It will introduce the participants to the fundamental tools of data presentation, tables and graphs, in all their myriad forms and uses. This course is an introduction to data presentation and should be taken before taking Data Presentation II: Flow Charts, Box Plots, and Other Advanced Graphics. Participant profile Medical writers and editors with 0–5 years of experience. Homework Pre-workshop assignment: 1-2 hours Post-workshop assignment: 1-2 hours
Workshop 20: European Regulatory Procedures for Medical Writers Stuart Woods (SmithKline Beecham Biologicals), Susan Bhatti (Merck dura) Objective To provide an introduction to the European regulatory institutions and European regulatory procedures. The course will explain the requirements for the use of the Centralised and the Mutual Recognition Procedures and explore the reasons for choosing a specific submission strategy. Emphasis will be focused on the differences between the processes and the contribution that medical writers can make to a successful submission. Workshop content The course will provide: An overview of current European regulatory procedures An introduction to European regulatory institutions An outline of the content of European dossiers Discussion of the Centralised and Mutual Recognition Procedures. How to use them most efficiently, and why and how the medical writer can contribute to this Participant profile Medical writers with no prior experience of regulatory affairs who are interested in obtaining a basic knowledge of European regulatory processes. Homework Pre-workshop assignment: 1 hour Post-workshop assignment: 2 hours
	Evening: See social programme