Tuesday | Thursday | Friday | Social | Overview

Wednesday 9 May Morning Workshop 5: Essentials of Editing and Proofreading Workshop 6: Writing Clinical Study Reports Using ICH E3 Workshop 7: Punctuation Workshop 8: From Protocol to Study Report: What’s In Between? Afternoon Workshop 9: The Package Leaflet Workshop 10: Do More With Less Faster: Project Management for Biomedical Communications Workshop 11. Information Sources for Medical Writers Workshop 12. Pharmacology for Medical Writers
	07.30 Registration begins 09.30 WORKSHOPS
	Workshop 5: Essentials of Editing and Proofreading Barbara Grossman (Covance), Marian Hodges (Freelance) Objective After completing this workshop, participants should understand how editing and proofreading contribute to the production of a high-quality document. They should be aware of the key processes involved, and be able to identify errors in text and to compile a simple editing checklist. Workshop content The workshop will focus on editing and proofreading as part of the work of a medical writer. Our aim is to give an overview of why editing should be part of document production and to discuss the procedures involved. We will consider the editorial process in terms of: substantive editing – rewriting and reorganising the document to ensure that the message is delivered effectively to the intended audience technical editing – checking for correctness, consistency and completeness proofreading to give a ‘final polish’. We will also discuss editing to a specified style (e.g. for submission to a journal) and how developing checklists and style sheets can increase efficiency in editing. Participant profile The workshop is intended for medical writers who edit or proofread their own work or that of their colleagues; it is not intended for people who specialise in medical editing. Previous attendance at another workshop is not required. Homework Pre-workshop assignment: 1-2 hours Post-workshop assignment: 3 hours
	Workshop 6: Writing Clinical Study Reports Using ICH E3 (Pharmaceutical) NB 09.00 start Stephen de Looze (Aventis) Objective This workshop is designed to introduce participants to the preparation of clinical study reports (including synopses and appendices) required for submission to regulatory authorities around the world, usually when applying for a product licence. 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, an understanding of statistical evaluation. Workshop content The course will cover: The elements of clinical study reports The application of ICH E3 and other regulatory guidance Typical problems and pitfalls when writing clinical study reports Quality control of clinical study reports The role of the individual report in a regulatory submission dossier After the workshop, participants should be able to: understand the requirements and processes for writing and assembling clinical study reports, synopses and appendices for all phases of clinical development; understand the role of individual clinical study reports in regulatory submission dossiers, and their role in developing summary documentation. Participant profile The course is intended for medical writers with little or no experience of writing clinical study reports, although participants should be familiar with the clinical development process. Homework Pre-workshop assignment: 2 hours Post-workshop assignment: 2-3 hours
	Workshop 7: Punctuation (Foundation) Alistair Reeves (Aventis) Objective Many writers are unsure about punctuation, and both native and non-native English speakers often misuse even the most common elements. The pre-workshop assignment, content of the workshop, and post-workshop assignment will provide participants with a solid grounding in the use of all punctuation marks in scientific texts, enabling them to approach writing and editing work with greater confidence. Workshop content The workshop will review the use of common - and uncommon - elements of punctuation, with the emphasis on English used in the pharmaceutical industry. It will provide hints on how to use commas, semi-colons, dashes and other members of the punctuation family, in order to improve readability and enhance style. Problem areas of punctuation will also be considered. Participant profile This workshop offers an opportunity for all native and non-native speakers of English - regardless of their experience and whether or not they earn credit - to refresh their knowledge of punctuation and take a critical look at some problems areas of punctuation. Homework Pre-workshop assignment: 1 hour Post-workshop assignment: 1.5 hours
	Workshop 8: From Protocol to Study Report: What’s In Between? Beate Wieseler (Kendle) Objective To be able to prepare a clinical trial report, a medical writer should have an understanding of how a clinical study is conducted and how individual patient data collected at an investigational site are converted into the results of a study. This workshop aims to provide an overview of the different steps of a clinical trial (clinical phase, data management, statistical analysis, report writing) with an emphasis on the handling of patient data. Workshop content Based on pre-workshop reading of the most relevant ICH guidelines, the different steps of a clinical trial will be discussed. These will include the clinical phase (basic regulatory requirements, monitoring), data management (data entry, data cleaning, coding) and statistics (analysis plan, steps of analysis). The flow of data from the investigational site to the study report will be summarised. Participants will identify relevant information needed for the preparation of a study report. Participant profile This workshop is designed for medical writers who are new in the field of regulatory writing. The workshop will provide an overview of the conduct of a clinical trial and cannot go into detail about each of the topics addressed. However, it may serve as a basis for other more specialised workshops. Homework Pre-workshop assignment: approximately 4 hours Post-workshop assignment: approximately 2 hours
12.30 Buffet lunch
	Workshop 9: The Package Leaflet (Pharmaceutical) Susan Bhatti (Merck dura), Julia Cooper (PAREXEL) Objective A package leaflet (also known as a patient information leaflet) must now be included in the packaging of all medicines. The clinical information in this leaflet should correspond to the relevant parts of the approved Summary of Product Characteristics and must be approved by the regulatory authorities. Surveys have indicated that many patients have difficulty understanding the information in these leaflets. As a result, the regulatory authorities are placing increasing emphasis on a user-friendly style. The medical writer can play an important role in producing a patient leaflet that is not only user friendly but also meets the regulatory requirements. This workshop will enable medical writers to achieve a basic understanding of the requirements for package leaflets in the EC and how to write a package leaflet, and how to identify the strengths and weaknesses of a package leaflet. Workshop content The workshop will cover the content of the European package leaflet and differences in the package leaflet for the Mutual Recognition and Centralised Procedures. Testing the package leaflet for readability will also be discussed. Participants will learn about the pitfalls of patient leaflets by producing a mini patient leaflet in small groups. Participant profile Medical writers with no prior experience of writing package leaflets and with basic knowledge of regulatory requirements. Homework Pre-workshop assignment: 2 hours Post-workshop assignment: 2 hours
	Workshop 10: Do More With Less Faster: Project Management for Biomedical Communications (Pharmaceutical) Art Gertel (iKnowMed) Objective Biomedical communications professionals, whether employed by the pharmaceutical industry, academia, government, or commercial enterprises, usually find themselves at the end of the documentation process. At this point they often have less time, lower quality source information, and fewer resources than originally planned. Applying sound project management theory and practice may actually go a long way toward minimising the discomfort of the ’eleventh hour‘. The pre-workshop assignment will assist the registrants in identifying their experiences of roadblocks to successful projects. During the workshop, strategies and suggestions for ’re-engineering‘ the organisational culture will be discussed. The value of the conversion of the medical writer to de facto project manager will be described. The follow-up assignment will call upon the participants to report on any success they may have had in applying project management techniques to their projects. Workshop content Discussion will include project management theory and practical applications both within the context of a matrix organisation and as an independent. A medical writing group may also adopt these practices to better control their own destiny. Participant profile Appropriate registrants would include medical writers, particularly those who work within, or for, pharmaceutical companies. They should have at least 1 year’s experience working within a matrix environment with responsibility for the preparation of component documents for registration dossiers. Homework Pre-workshop assignment: 3 hours Post-workshop assignment: 2 hours
	Workshop 11. Information Sources for Medical Writers (Foundation) Alison Rapley (PAREXEL) Objective Medical writers often need access to up-to-date relevant information in order to produce good quality documents. This workshop will help writers to decide how and where to obtain the information they require and at what cost. Workshop content Participants will discuss the role of published biomedical reference tools, CD-ROMs, on-line databases and Internet sources, and examine examples from each of these four areas. Strengths and weaknesses of each source will be discussed as well as approximate costs.The workshop will provide tips on the best databases and Internet sites to use and how to search them effectively; however detailed information on search techniques for specific databases is outside the scope of this workshop. Specific information problems can be raised in the pre-workshop needs analysis questionnaire for discussion during the workshop. Participant profile All medical writers who need to obtain specific medical information in order to complete their writing tasks. The workshop will be useful to writers ranging from those working for pharmaceutical companies/CROs with large medical information departments to freelance medical writers with no information support. Resources/material required Attendees will need access to the Internet in order to complete their pre-workshop assignment and post-workshop assignment. Homework Pre-workshop assignment: 2.5 hoursPost-workshop assignment: 2 hours
	Workshop 12. Pharmacology for Medical Writers John Carpenter (Oxford Clinical Communications) Objective This course is designed to provide medical writers with a sound background knowledge of the way drugs work and how their properties should be described. It is aimed primarily at those who have not had any formal instruction in pharmacology (and those whose knowledge is now out of date). Workshop content This workshop will cover: The main ways in which drugs produce their effects (in general terms, and with specific understanding of key drugs in some important therapeutic groups) The ways in which new drugs are investigated and tested The properties of drugs in important therapeutic groups How to use internationally agreed terminology for describing drug actions and the properties of drugs. There will be a 30-minute period at the end of each session during which delegates will be given appropriate exercises.During these periods they will also have the opportunity for further discussion of issues raised during the session. Participant profile Participants will normally be writers who either: Have had no formal instruction in pharmacology Have undertaken formal instruction in pharmacology in the past but who wish to update their knowledge. Homework Pre-workshop assignment: None Post-workshop assignment: 1 hour
	Evening: Conference banquet