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Tuesday 8 May Afternoon only Workshop 1: Targetting Your Audience Workshop 2: Using Statistics in Medical Writing Workshop 3: Writing Global Clinical Submission Dossiers Workshop 4: Understanding Research Ethics Committees Evening: Informal get-together
	10.00-19.00 Registration 14.30 WORKSHOPS
	Workshop 1: Targetting Your Audience Julia Forjanic Klapproth (Aventis), Jane Stock (Freelance) Objective The primary goal of writing is to convey information to a target audience. This workshop will explore the undamental concepts of how a writer can express the same story to vastly varied audiences. The pre-workshop material, the workshop and the post-workshop assignment will ntroduce, actively explore and exercise the different writing styles commonly used in medical writing, emphasising which style is most effective for each audience, and why. Participants will learn and develop one of the fundamental principles of good writing: recognise who you are writing for and write for them Workshop content The basic philosophy of considering the purpose of a document will be presented and discussed. Real-life examples (good and bad) and hands-on writing with discussion will demonstrate how to use different writing styles in different contexts, from manuscripts to marketing information. Participant profile Anyone who wants to develop their fundamental writing skills by building on the philosophy of writing and the writer’s role in expressing an idea in many ways. Anyone interested in gaining some practical insight into areas of writing (from PR to regulatory) they may not encounter on a daily basis. Homework Pre-workshop assignment: 1 hour Post-workshop assignment: 2–3 hours
	Workshop 2: Using Statistics in Medical Writing (Foundation*) Barry Drees (Aventis) Objective At the end of the course participants should be able to understand the following: Populations to be analysed: intention-to-treat, per-protocol, safety-evaluable, worst case Variables: response (dependent) and explanatory (independent) Levels of measurement: qualitative (nominal and ordinal) and quantitative (discreteand continuous) Descriptive statistics: mean, median, mode, range, percentiles, box plot, normal and non-normal distributions, parametric and nonparametric tests, coefficient of variation Estimates and confidence intervals: probability, standard deviation, standard error of the mean, p-values Sample size calculations and what they mean Statistical hypothesis testing (time permitting) Workshop content We all write about statistics, but how many of us really have an intuitive feel for what we're writing about? This workshop is designed for participants who have little or no background in statistics. The following statistical concepts will be covered in depth: types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and sample size calculations. Emphasis will be placed on understanding statistical presentations and reporting statistical information, not on calculations or mathematical explanations. Participant profile Medical writers and editors with any level of experience who wish to learn more about the statistics they work with. Homework Pre-workshop assignment: 2-4 hours Post-workshop assignment: 2 hours
	Workshop 3: Writing Global Clinical Submission Dossiers (Pharmaceutical) NB 14.00 start Stephen de Looze (Aventis) Objective This workshop is designed to introduce participants to the preparation of clinical submission dossiers required for submission to regulatory authorities around the world when applying for a product licence. The European dossier will be dealt with in detail, but the way in which general principles of summary writing can be applied to other dossiers, especially the American dossier, will be explained. The emphasis of the workshop will be on medical writing within the scope of a multidisciplinary team, and so it will focus on writing aspects rather than on, say, a detailed understanding of the regulatory submission process. Workshop content The course will cover: The components of a clinical submission dossier Different types of clinical summary documents Building summaries from individual study reports Regulatory guidance for preparing an American and a European clinical submission The European clinical expert report and written summary Customising ’global‘ summaries for submission dossiers in different regulatory regions The Common Technical Document (ICH M4) Assembly and quality control of clinical submission dossiers After the workshop, participants should be able to understand: the overall structure of clinical submission dossiers; the requirements and processes for writing clinical summary documents; the limits of the available regulatory guidance; the forthcoming ’Common Technical Document‘ from ICH. Participant profile The course is intended for medical writers with little or no experience of writing clinical submission dossiers, although participants should be familiar with the clinical development process and have had some experience of writing clinical study reports. Homework Pre-workshop assignment: 2 hours Post-workshop assignment: 2-3 hours
	Workshop 4: Understanding Research Ethics Committees (Pharmaceutical) Geoff Hall, Freelance, Vice-chairman, Research Ethics Committee, Royal Brompton and Harefield NHS Trust and The National Heart and Lung Institute, Imperial College, London, Member of the National Council of the Association of Research Ethics Committees (UK) Objective At the end of the course participants should: Understand the structure and composition of research ethics committees (RECs) Appreciate the origins of and need for independent ethical review of research involving human subjects (i.e. The Helsinki Declaration) Know the general principles under which ethical review is conducted Appreciate the deliberation process and priorities of RECs Understand some of the implications of the EU Directive on Good Clinical Practice in Clinical Trials for RECs   Workshop content The Helsinki Convention as revised in Edinburgh, October 2000 Structures, composition and functions of RECs The implications of the EU Directive on Good Clinical Practice in Clinical Trials for RECs and independent review The place of multi-centre research ethics committees (MRECs) Role play. Participants will form two committees, each of which will review a fictitious application for ethical approval Discussion Participant profile Medical writers and project managers involved in clinical studies; new or aspiring members of RECs. Homework Pre-workshop assignment: 1-2 hours Post-workshop assignment: 1-2 hours * Workshop approved for credit for the indicated option in the EMWA Professional Development Programme
	Evening: Informal get-together