Programme

44th EMWA Conference - Birmingham

2-6 May 2017

See Fees and Registration for details of fees for events (including EPDP workshops) and waiting lists for events that are full.

Note that most EPDP workshops have pre-workshop assignments, which you can download directly using the links below. If you attend EPDP workshops and successfully complete the assignments you can gain EPDP credits, which can allow you to apply for an EMWA certificate. See the EPDP brochure for details. However, you are welcome to attend workshops without doing them for credit.

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Tuesday 02 May

16:00
to
20:00

Registration
17:30
to
19:00

Content

17:30 Chair and Conference Director’s welcome including presentation of awards

17:40 Portuguese People and Saudade
Maria João Pisco Almeida

18:30

19:00 Close of opening Session
19:00
to
20:45

Networking Reception
Social

Wednesday 03 May

08:00
to
08:30

Content

(formerly called Working in and on Your Business)
This seminar is free-of-charge and is primarily for freelance medical writers who have to juggle client demands with those of their business. Many freelancers struggle to find time to manage their personal and business needs whilst meeting client demands and deadlines. This seminar will introduce and explore the concepts of working ‘on your business’ as well as ‘in your business’, describing processes, systems and practices which may be implemented to help freelancers manage their business more efficiently while managing their clients more effectively.
08:45
to
11:45

PTF24
Information Sources for Medical Writers
Professional Techniques - Foundation

Participant Profile

Medical writers often need access to up to date relevant information in order to complete their writing tasks. The workshop will be useful to all writers ranging from those working for pharmaceutical companies and CROs with large medical information departments, to freelance medical writers with no information support. This workshop was previously run under the code PTF2 but it has changed significantly.

Objectives

The aim of this workshop is to enable writers:
• to determine how and where to obtain the information they require
• to identify reliable information sources
• to be more confident and effective in searching the internet

Content

This workshop will discuss the different types of information sources available including on-line databases, and web sites. It will provide information on the different database providers, what type of information is available from on-line databases and how to choose the most relevant databases and web sites.
It will provide tips on the use of search engines, including some specific medical search engines, and provide a practical example of how to use PubMed to search MEDLINE, (one of the major bibliographic databases for medicine).

The workshop will include a practical exercise in identifying appropriate sources to obtain information.

Attendees will need access to the internet in order to complete their pre-workshop assignment and post-workshop assignment. However no previous experience of internet use is required and access to fee based services will not be required.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
11:45

PTF4

Participant Profile

The workshop is aimed towards medical writers at all levels of experience, and whether working in a freelance capacity, or within a CRO environment, or for a pharmaceutical company. It will be an ideal forum for those who either have no quality control (QC) system in place, or are looking to develop one, whilst those with experience of working with, or implementing QC systems will be able to explore and share best practice. It is not necessary to have attended any other workshops.

Objectives

For a medical writer the correct application of a QC process minimises errors in the factual presentation of data, rectifies spelling mistakes and ensures accurate document structure. At the end of the workshop, participants should have an understanding of why it is important to have a QC procedure in place for written documents including clinical study reports, when in the writing process QC should be implemented, and how to document the results.

Content

The importance of QC in medical writing will be covered. The consequences of not implementing and following a QC process will be discussed. QC requirements, who should perform the task, and how to carry it out will all be addressed. The workshop is designed to both inform and share experiences; therefore interaction of participants will be actively encouraged. Although the workshop is applicable to other types of medical writing it will primarily use clinical study reports as working examples.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

DDF20
GCP Training for Medical Writers
Drug Development - Foundation

Participant Profile

This workshop is intended for writers with little Good Clinical Practice (GCP) experience whose work involves clinical trial documents e.g. informed consent forms, protocols and reports.

Objectives

An understanding of the principles of GCP and how they can be applied in the writing and reviewing of clinical research documents e.g. informed consent forms, clinical study protocols, and regulatory documents e.g. clinical study reports, clinical overviews and summaries.

Content

The first part of the workshop will provide an overview of the principles of GCP, including the Declaration of Helsinki, the ICH E6 GCP Guideline and the Clinical Trial Directive 2001/20/EC and its amendments. The second part of the workshop will focus on how to ensure that documents are GCP-compliant, and the cross-checks that can be made, particularly when writing clinical study reports.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

Content

See ESS page for further details
08:45
to
12:15

PTF28
Powerpoint for Medical Writers
Professional Techniques - Foundation

Participant Profile

This workshop is aimed at medical writers looking to begin using Microsoft PowerPoint, or to refresh their basic skills.

Objectives

The objective of the workshop is to give an overview of some of the functions of Microsoft PowerPoint, beginning from the very basics, and provide a practical guide to their use. There will be several hands-on exercises during the workshop for which a laptop with PowerPoint installed would be helpful, although is not essential.

Content

The workshop will begin with the basics of creating a new slideshow, adjusting slide formatting and using master slides, and inserting text and graphics. We will then examine the use of animations, including how to apply different effects to an object, and how best to animate graphs to enhance the presentation of scientific data. Finally, the use of hyperlinks and custom shows will be explained.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:00hrs

08:45
to
12:15

DDA21

Participant Profile

Medical writers with experience in regulatory writing. Experience and understanding of the regulatory requirements for the market approval of medicinal products is expected. Participants should know how medical devices are classified or have participated in the workshop “Introduction to Writing for Medical Devices”.

Objectives

To provide insight into the Clinical Evaluation of Medical Devices, which is an essential requirement for introducing a new medical device to the European market and is also a “vigilance” document which has to be updated regularly.

Content

Focusing on medium and high risk medical devices, the workshop will introduce:

• The Technical or Design Dossier (equivalent to the CTD for medicinal products)
• The Clinical Evaluation and its role in the market approval process
• The “literature” based Clinical Evaluation (when it can be used and how to write it)
• The Clinical Investigation and the Clinical Investigation Plan for high risk devices, including when it is necessary to run a clinical investigation with a new medical device.
• The most common sources for the scientific and vigilance data required for a Clinical Evaluation.

The workshop will include group exercises and discussions as well as evaluations of real documents.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

DDF35
Introduction to Writing about Efficacy
Drug Development - Foundation

Participant Profile

This workshop is aimed at medical writers with little or no experience of writing about efficacy in clinical and regulatory documents. Basic knowledge of the clinical development process is expected.

Objectives

The workshop aims to give participants a basic understanding of the general principles by which efficacy is evaluated in clinical trials. Participants will gain a broad awareness of the different kinds of efficacy endpoints and statistical analyses they are likely to encounter. The focus is not on detailed statistical theory, but on practical approaches to understanding efficacy analyses and reporting their results in a clinical study report, regardless of clinical indication. The workshop includes exercises designed to give participants hands-on practice at using statistical analysis plans to understand and describe efficacy analyses, and at interpreting data tables for efficacy. After completing the workshop, participants should be better equipped to write the efficacy sections of clinical documents.

Content

The workshop will cover: Introduction to efficacy • How is efficacy evaluated? The relationship between study objectives, endpoints, and assessments • How are efficacy endpoints chosen? • Different categories of efficacy endpoint and associated data • How are efficacy endpoints analyzed? • Writing efficacy methodology sections • Reporting efficacy results

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
12:15

DDA5
The CTD Clinical Overview
Drug Development - Advanced

Participant Profile

This workshop is aimed at writers with experience in writing study reports but who are new to writing Clinical Overviews for the Common Technical Document (CTD).

Objectives

The purpose of this workshop is to look at creating the optimal CTD Clinical Overview that achieves its purpose. On completion of the workshop package, participants should be able to approach writing a CTD Clinical Overview with a better understanding of the expectations of a Regulatory Authority Assessor.

Content

The workshop will begin with a brief presentation on what a Clinical Overview is and how it fits into the dossier as a whole. This will then be followed by an overview of the Clinical Overview structure and the important points within each section. Finally there will be some pointers about what a regulatory reviewer wants from a Clinical Overview. Participants will then have the opportunity to take part in a group exercise drafting a Product Development Rationale section based on information provided in the workshop.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

MCF2a
Developing a Communication Strategy for your Brand
Medical Communication - Foundation

Participant Profile

Medical writers and other professionals working in pharmaceutical, medical devices or communication agency environments who want to know more about the processes involved in developing a communication strategy for a brand.

Objectives

For many people, communication strategy is perceived to be a ‘dark art’. Although it drives the tactics we implement in our everyday work life, such as manuscripts and symposia, the processes through which the communication strategy for a brand is developed can remain elusive. This workshop will present a stepwise process that can be used to develop an effective and meaningful communication strategy for a brand and then, through interactive mock strategy workshop sessions, show how this process can be implemented in practice.

Content

The objective of this workshop will be achieved by providing participants with an overview of the key elements of strategy development within a framework of a mock strategy workshop. Participants will be taken through the five key steps of strategy development: (1) audience identification and segmentation; (2) market and competitive overview; (3) defining product attributes and positioning; (4) identifying commercial opportunity and critical success factors; and (5) defining communication objectives and themes. The participants will be able to put into practice what they have learnt, taking part in a series of interactive mock strategy workshop sessions to identify unmet clinical needs and target audiences, assess the strengths and weaknesses of Product X, rate and rank differentiating product attributes, and develop a unique positioning for Product X. As part of the pre-workshop assignment, participants will be asked to review some pre-reading on the therapeutic area, so that the benefit of participating in these interactive workshop sessions can be maximised.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

Participant Profile

This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).

Objectives

The objective of this workshop is to equip you with the essential skills required for the management and preparation of high quality CSRs. This includes in-depth sessions on both the writing of CSRs as well as their project management. The workshop will include group exercises and discussions so that participants can develop new skills attained and learn from each other’s experiences.

This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the production of CSRs.

Content

The course will cover:
• CSR project preparation and timelines
• Writing a CSR according to International Conference on Harmonisation (ICH) E3 guidelines and CORE reference
• Writing the methods sections: brief overview and advice
• Interpreting data, describing results: demography and baseline characteristics
• Interpreting data, describing results: efficacy; using the statistical report
• Interpreting data, describing results: safety and safety narratives
• Different types of CSRs: abbreviated CSR, full CSR, post-marketing reports, medical device reports
• CSR review and quality control
• Appendices: an overview

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

10:15
to
11:00

Refreshment break
11:45
to
13:15

Lunch
12:45
to
13:15

EMWA/AMWA/ISMPP Joint Position Statement
13:30
to
16:30

DDF6b

Participant Profile

This workshop is designed for medical writers who are new in the field of regulatory writing and clinical development. The workshop will provide an overview of the conduct of a clinical trial. Although the workshop does not go into detail about each of the topics addressed, it will serve as a basis for more specialised workshops.

Objectives

After the workshop the participants 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 study results. This workshop aims to provide an overview of the different steps of a clinical trial (clinical phase, data management, statistical analysis) with an emphasis on the handling of patient data. Based on this overview a medical writer should be able to improve the description of study conduct and study results in an integrated study report.

Content

Based on pre-workshop reading of the most relevant ICH guidelines, the different steps of a clinical trial will be discussed. This will include the clinical phase (basic regulatory requirements, monitoring), data management (data entry, data cleaning, coding, electronic data capture) 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.

Pre-Workshop Assignment Length: 4:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
16:30

DDF39
An Overview of Healthy Volunteer Studies
Drug Development - Foundation

Participant Profile

This workshop is for medical writers who would like to gain insight into the unique aspects of clinical trials conducted with healthy volunteers rather than patients (such as Phase 1, thorough QT, and bioequivalence studies).

Objectives

Healthy volunteer studies make up a large proportion of studies in most clinical development programmes. Medical writers working on documents for these studies need to understand how they differ from clinical trials in patients. After attending this workshop, the participant will understand the design issues and data collected in healthy volunteer studies.

Content

This workshop will cover the following topics for healthy volunteer studies:
· Key regulatory guidance documents
· Populations studied
· Study designs and objectives
· Types of assessments

Note: Phase I studies in patients will not be covered.

Note: Content in this workshop was previously included in Workshop DDA18. (Medical Writing for Healthy Volunteer Studies)

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:00hrs

13:30
to
16:30

PTF25
Patient Registries as a Source of Medical Information
Professional Techniques - Foundation

Participant Profile

This workshop addresses medical writers who prepare publications based on the data from research databases, patient registries and other real-life data sources. Basic knowledge of the design of observational studies, epidemiological research and statistics is not critical, but would be beneficial.

Objectives

To present the pros and cons of real-life research, to teach how to avoid over-interpretation of the study results, and to present these data effectively. Finally, to position patient registries as a complement to experimental studies.

Content

Nowadays, real-life medical data sources such as research databases or patient registries are gaining in importance as a source of medical information, and medical writers are often involved in preparing manuscripts based on these data. However, it should be highlighted that the way these data are reported differs from the way the data from experimental trials are presented. This workshop focuses on the basic concepts of real-life medical research, the differences between the data from real-life settings and experimental trials, the ways of publishing them, and the issues medical writer must think of while writing such papers. Furthermore, it will present the overview of the main aspects of analysis and interpretation of the registry data, including specific statistical problems (but without going into mathematical details). The workshop will include examples of registries and relevant papers to illustrate the potential of this kind of research.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:30hrs

Content

See ESS page for further details

Participant Profile

This workshop is intended for medical/scientific writers who work on different aspects of company-sponsored satellite symposia at scientific congresses.

Objectives

Satellite symposia are complex events and the medical writer might be involved, not just in developing content or preparing outputs, but may be required to help co-ordinate the event, secure company clinical, medical and legal review, facilitate slide rehearsals and liaise with the faculty panel. The purpose of this workshop is to consider the separate elements of organising and delivering company-sponsored symposia to thereby expose the writer to tasks which they might encounter.

Content

The workshop will start at the planning stage and consider all aspects of symposium preparation, including project management, working with logistics agencies and faculty, developing slides following company and country rules, writing proceedings, compliance with EFPIA and Sunshine Act requirements as well as financial reconciliation.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

DDF38a

Participant Profile

Regulatory medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers, who write or review clinical study reports (CSRs). The workshop will meet the needs of writers and reviewers in interpreting existing International Council for Harmonisation (ICH) guidelines that drive preparation of CSRs, and in ensuring that CSRs are written in accordance with the principles of responsible clinical trial data sharing. Participants must have written at least one CSR or reviewed several, and have working knowledge of International Council for Harmonisation (ICH) reporting guidelines.

Objectives

The current ICH guidance on CSR authoring is ICH E3 (1995) and the 2012 Questions and Answers (Q & A) Revision document. Inconsistencies in interpretation require clarification, and indeed this is recognised specifically for ICH E3 in the 2012 Q & A document. CORE Reference (see http://www.core-reference.org/) launched on 03 May 2016, provides interpretational guidance on CSR authoring that incorporates regional (EU and US) and real-world insights. These include guidance on writing CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements. Participants will acquire the knowledge and skills required to author or review fit-for-purpose CSRs that belong in the modern drug development arena.

Content

· Background to CORE Reference· Description of CORE Reference complete web-based resource
· Common inconsistencies in ICH guideline interpretation and how CORE Reference addresses these issues
· Background to transparency and public disclosure requirements
· How CORE Reference deals with the challenges of responsible clinical trial data sharing.

Pre-Workshop Assignment Length: 3:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

LWF8
Sharpen Up Your Writing Skills
Language and writing - Foundation

Participant Profile

This workshop will be useful for anyone who wants to make their writing more effective. It will be particularly useful for those who have come into medical writing without receiving any training in writing skills.

Objectives

The objective of the course is to help participants write clear, professional text that communicates effectively with their target audience. We will focus on writing for STM (scientific/technical/medical) audiences and for patients and the general public, but the skills taught are applicable to all types of written communication.

Content

If we do not persuade our audience to start and then continue reading, our effort as writers is wasted. It is also wasted if readers fail to understand the intended message, or if we lose credibility through poor presentation. The workshop looks at the principles of effective writing, and how to use them to achieve your communication goals. Topics covered include:
• Structure and style: the do’s and dont’s of effective writing
• Achieving clarity without ‘dumbing down’
• Common style traps in STM writing
• Writing for patients and the public
• Writing to persuade: make your writing powerful
• Say it concisely: tips for reducing word count
The course contains interactive class exercises, and learning points are illustrated using real examples of good and bad medical writing.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 1:00hrs

13:30
to
17:00

MSA1
Advanced Epidemiology
Medical Science - Advanced

Participant Profile

Experienced writers with basic knowledge of descriptive statistics. Participants are strongly recommended to take the “Basics of Epidemiology for Medical Communicators” workshop before enrolling in the advanced workshop.

Objectives

This workshop is designed for experienced medical writers. The underlying principle is that medical communicators have a key gatekeeper’s role in ensuring correct interpretation of medical findings. Participants will be provided with advanced data interpretation insights according to epidemiological concepts. Focus is on the critical appraisal of reported medical findings and the application of epidemiological tenets to improve their own writing. Commonly used measures of association including relative risk and odds ratios as well as research designs and causality development will be discussed. Contemporary examples from clinical medicine, public health and pharmacoepidemiology will be used in class format combining lectures with group exercises.

The main objectives are:
• Provide advanced data interpretation insights based on epidemiological principles
• Apply a checklist (STROBE) useful for the critical appraisal of medical communications and for sprucing up medical writing skills

Content

Three major topics will be covered:
• Basic measures of association
• Overview of “good” research design characteristics and common research designs used in epidemiology - pros and cons
• Association and causation - making sense of a confounding couple

Pre-Workshop Assignment Length: 3:00hrs

Post-Workshop Assignment Length: 1:00hrs

13:30
to
17:00

LWA12
Master Class: Taxonomic Analysis of Medical Writing
Language and Writing - Advanced

Participant Profile

Experienced medical writers.

Objectives

To enhance the recognition, analysis, and revision of writing distractions.

Content

Do you want to gain insight into your medical writing syntactic distractions—insight that will enhance their recognition and revision?
If so, the following 3 levels of activities may be for you.
1. Preworkshop: Revise the distractions in a set of 5 sentences and prepare to discuss your reasons for revision.
2. Workshop: from a compilation of all the submitted anonymous revisions, you (along with a workshop partner) will vote for the clearest and most succinct, then enter a discussion with all registrants and the workshop leader as to the reasons for the selection
3. Postworkshop: With the guidance of the workshop leader, prepare a taxonomic profile of the distractions in your revisions.

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

14:15
to
15:00

Refreshment break
17:15
to
18:15

Annual Meeting
19:30
to
23:30

EMWA Spring Dinner and Dance
Social

Thursday 04 May

Participant Profile

New to medical writing? Interested in making the switch from academia to pharma? This short presentation gives a brief introduction to the regulatory side of medical writing, compares and contrasts academic writing and regulatory writing, and gives a few tips on how to making the transition.

Participant Profile

Getting a first medical writing job is difficult because there are very few educational opportunities and because employers always want experience.This situation creates vicious cycle where it's seemingly impossible to get experience without already having some. Phil Leventhal, Editor-in-Chief of Medical Writing and member of EMWA's Executive Committee, will share how he got a foot in the door, and he will discuss ideas for building writing experience needed to land a first job in medical writing.
08:45
to
11:45

MSF11
Fundamentals of Haematology
Medical Science - Foundation

Participant Profile

Medical writers (and other interested professionals) with little or no background in haematology, and participants interested in refreshing or increasing their knowledge of haematology.

Objectives

The workshop has two main objectives. The first is to increase the participants’ knowledge of the basic principles of (clinical) haematology. The second objective is to support and improve the participants’ understanding of the development, approach and results of current therapies in haematology.

Content

This workshop will consist of a mixture of lectures and interactive elements. The basic principles of haematology, and the current clinical and laboratory practice will be introduced. Topics will include the development, structure and function of haematopoietic cells and organs, an overview of common haematological diseases and their therapies, and typical procedures and results of clinical studies.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
12:15

PTA11
Strategies for Improving Document Quality
Professional Techniques - Advanced

Participant Profile

This workshop is suggested for experienced medical writers, particularly those who are in a supervisory role, or who will soon be taking on that responsibility.

Objectives

This workshop is designed to provide insights into effective policies and procedures that contribute to document quality. On completion of the workshop and class exercises, participants should be better able to apply pragmatic methods and behaviours that enhance awareness of the elements of document quality and lead towards more effective management of the process.

Content

Improving the process of document preparation is crucial for medical writers. Discussion will include mechanisms for enhancing quality and accountability, and for ensuring adequate time allowances. These are organisational issues around which a medical writing group can build policies aimed at ensuring a higher degree of accountability among those with whom they work and upon whose input they depend. Quality measures established by authoritative standards, as well as those that may be developed internally, are explored. Suggestions for effective management and departmental structure will also be provided.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
16:30

LWF13+14
Editing and Proofreading Essentials (Double Workshop)
Language and Writing - Foundation

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.

Objectives

This workshop aims to give an overview of editing and proofreading. After completing this workshop, participants should be able to:
• Appreciate how editing and proofreading contribute to document quality
• Identify and correct substantive and technical errors
• Proofread and clearly show changes that need to be made
• Compile style guides and editing checklists

Content

In this workshop, we will:
• Review the need for both editing and proofreading
• Focus on substantive editing: reorganising and editing to ensure that the correct message is delivered effectively and specifications are met
• Discuss how to work effectively with the author
• Focus on technical editing: getting down to the detail, including checking for format and consistency
• Look at proofreading, to give a ‘final polish’
• Consider tools to help the editor

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 4:00hrs

09:00
to
13:00

Participant Profile

The Live Internship Forum will take place on Thursday 4th May 2017 (half day) at our next Spring conference in Birmingham, United Kingdom. This is an opportunity for companies and prospective medical writers to meet and network. Up to 10 companies will be invited to participate in the live event (selected on a first come first served basis). The first half is an informal meet-and-greet, whereby applicants can speak to any company of their choice. The second half of the forum will include pre-booked meetings.
09:00
to
17:00

Transparency and Disclosure of Clinical Regulatory Documentation
Symposium
10:15
to
11:00

Refreshment break
11:45
to
13:15

Lunch
12:45
to
13:30

Content

Abstracts accepted for poster presentation will be presented by authors in Hall 4 between 12:45-13:30
13:30
to
17:00

MCA5
Writing for the Public
Medical Communication - Advanced

Participant Profile

This workshop would suit medical writers who have had experience of preparing different types of regulatory documents, and who may be involved in producing documents for patients or other lay audiences. It would also benefit writers involved in medical communications who may be asked to produce written information aimed specifically at non-specialist audiences.

Objectives

The workshop aims to explain the challenges posed by low health literacy and numeracy and will explain why this topic is of such importance to the healthcare professions and the pharmaceutical industry. Participants will be given practical examples and shown ways to address these challenges, including how to clarify and improve communication of benefit/risk.

Content

The workshop will outline the difficulties involved in writing for audiences with lower health literacy and numeracy than specialist audiences, and will explain the potential impact this can have on the understanding of concepts such as benefit/risk. The leaders will give examples of how these issues can be addressed, along with general guiding principles. The participants will have the opportunity to practise these in two workshop exercises, one a discussion of their ‘translation’ of a complex text into a more lay-suitable one (an analysis of their pre-workshop assignments), and the other an outline of what should be included in a Risk Management Plan (RMP) lay summary (to be completed as their post-workshop assignment).

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

MCF16
Publication Ethics
Medical Communication - Foundation

Participant Profile

This workshop is intended for all medical and scientific writers who are involved with the preparation of medical publications

Objectives

The purpose of this workshop is to introduce medical and scientific writers to current ethical controversies in biomedical publication and the guidelines that have been developed to help avoid such ethical issues.

Content

The workshop will cover ethical issues that may be encountered when publishing biomedical research. Plagiarism, authorship, ghost writing, prior publication, over- and under-reporting, conflicts of interest and the role of industry, are amongst the topics that will be examined. The guidelines that impact upon medical writing and their practical application will be explored. Participants will discuss recent examples that highlight ethical dilemmas. The two presenters will provide an author and journal perspective.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

14:15
to
15:00

Refreshment break
17:15
to
19:00

Freelance Business Forum
Discussion Forum
19:30
to
22:30

Tour options
Social

Friday 05 May

08:00
to
08:30

Participant Profile

We are delighted to offer another opportunity for EMWA members to learn from each other.
People who work from home often find that they miss the support of an IT department and office colleagues who can answer a quick question on how to do something, or show them a useful shortcut. Solutions to problems can often be shown quickly compared with the hours that can be spent using internet searches, help lines etc. Useful tips on making the most of software can be demonstrated in a moment. It is also easy for freelancers and other home workers to miss out on new software and Apps that could be very useful tools. So, in the EMWA spirit of sharing what we know, why not come along to this informal session of demonstrations and mini master classes. The precise content will depend on who takes part but will include social media, other Apps that can be particularly useful for medical writers, and ‘work horse’ software such as Word.
08:45
to
11:45

PTF21
Health-related Quality of Life
Professional Techniques - Foundation

Participant Profile

This workshop is aimed at medical writers who deal with health-related quality of life instruments (HRQoL) in clinical studies or document writing. No prior experience with HRQoL instruments is needed.

Objectives

The workshop will give an overview of the different types of HRQoL instruments and the main issues to be considered when using these measures in clinical studies. Participants will learn how to appraise HRQoL measures and acquire a better understanding of HRQoL data.

Content

1. What is HRQoL and why measure it?
2. Instruments for measuring HRQoL (generic vs. specific, profile vs. preference-based measures)
3. Using HRQoL instruments in a study
- choice of measure
- modes of administration
4. Reporting and interpreting HRQoL data

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

MCF22
Developing Effective Oral Presentations
Medical Communication - Foundation

Participant Profile

This workshop is suitable for participants looking to improve their skills in the development of medical communication materials for scientific oral presentations. Previous experience in this area is not required; participants will benefit from this workshop whether they are already working in medical communications and would like to improve their skills, or are looking to move into this area.

Objectives

The objective of the workshop is to equip participants with the skills necessary to produce effective oral presentations, whether working on behalf of clients or authors, or looking to improve their own presentations.

The workshop will consider the purpose of presentations as a means of communicating scientific findings, and how this can best be achieved through the use of effective data presentation and slide layout, and eye-catching visuals.

The workshop will consider the purpose of presentations as a means of communicating scientific findings, and how this can best be achieved through the use of effective data presentation and slide layout, and eye-catching visuals.

Participants will learn:
· Efficient and striking ways of presenting data
· How to prioritise information to avoid over-crowding a presentation
· Practical approaches to managing presentation projects and the development process
· How to gain maximum engagement from presentation attendees, and communicate the key messages

Content

Through a mixture of lectures, interactive group activities and group discussions, participants will learn:
· Efficient and striking ways of presenting data
· How to prioritise information to avoid over-crowding a presentation
· Practical approaches to managing presentation projects and the development process
· How to gain maximum engagement from presentation attendees, and communicate the key messages

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:00hrs

Content

See ESS page for further details

Participant Profile

This workshop is for medical writers who want to engage in the writing of lay summaries of study results as mandated by the EU regulation. Participants should already have an understanding of CSR structure (ICH E3) and should know the basics of clinical research (trial design, efficacy and safety analysis, basic statistics).

Objectives

Writing lay summaries is a difficult and challenging task. Medical writers with an interest in lay writing are well suited for this new and upcoming activity. However, the provision of lay summaries requires a lot more than good lay language writing. The workshop will introduce the many different aspects of providing lay summaries: the available regulatory guidance, the positions of various stake holders (pharma and patient organisations), the intricacies of actual the writing of lay summaries, and considerations for appropriate distribution of the lay summaries.

Content

The workshop will introduce the requirements for lay language summaries of study results according to the EU regulation. The various guidance documents from stakeholders (HRA, TransCelerate, MRCT, European Commission) will be reviewed, appraised, and discussed. The content requirements for lay summary will be presented and possible solutions will be discussed. As lay language writing is difficult and complex, only the basic principles of plain language writing will be covered. To appreciate the complexity of lay language writing in a confined context, the workshop will have a practical exercise as participants will be asked to write a short paragraph of a lay summary. In addition the various distribution options for lay summaries and the issue of translations will be discussed.

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

MSF4a
Pharmacogenomics
Medical Science - Foundation

Participant Profile

This workshop is aimed at medical writers with little or no understanding of the basics of pharmacogenomics and its applications in drug development, and those who may be working on projects that include pharmacogenomic substudies. A basic knowledge of genetics is essential, however, the three main principles of genetic theory (replication, transcription and translation) will be reviewed.

Objectives

The objective of this workshop is to provide participants with an understanding of how drug response is affected by inherited differences, and how this knowledge is applied to drug development. Implications to medical writers (including issues such as ethics and regulations) will be addressed.

Content

Participants will learn the basics about pharmacogenomic studies and their impact on drug development, and document (protocol, clinical study report and informed consent) writing. Animations will be used as much as possible to illustrate genetic concepts. A few successful stories (case studies) of marketed pharmacogenomic drugs (e.g., oncology) will give a glimpse of what the industry has achieved so far.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

Participant Profile

This workshop is intended for all medical writers, both native English speakers and those for whom English is a second language, who edit the work of authors who are not native speakers of English. The workshop will be of interest both to those who edit occasionally for colleagues and to people who edit extensively.

Objectives

Editing the work of others is a common component of medical writing. This activity can be especially challenging if the original author was not a native speaker of English and problems of poor writing skills are compounded by lack of fluency in the language. This workshop will give medical writers training and feedback in this sensitive task.

Content

This workshop will take the form of a master class, with a maximum of 12 participants. The workshop leaders see themselves primarily as facilitators and guides in achieving results. That is to say there will be almost no lecture content. Based on examples provided by the workshop leaders, participants will work together in small groups to improve a text after which feed back will be provided all together. Depending on availability it is hoped that other experienced editors will join the class as facilitators. At the end there will be a discussion session on providing feed back to the original author. The emphasis will be on generating texts that communicate clearly rather than reviewing grammar rules.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

MCA4
Manuscript Writing: from Good to Excellent
Medical Communication - Advanced

Participant Profile

Participants should have some experience with writing scientific papers. The workshop is relevant for those who write or edit articles for others, and for those who wish to improve their own research articles.

Objectives

To get a better understanding of how to effectively develop and improve manuscripts.

Content

Formulating research questions, establishing the storyline and developing content, with focus on structuring arguments by use of the Toulmin method; i.e. explaining why or how data support a conclusion and arguing that strengths are stronger than limitations.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
12:15

MCF21
Promotional Medical Writing: the Dark Side
Medical Communication - Foundation

Participant Profile

• Medical writers that have worked primarily on the regulatory side with a desire to expand into promotional medical writing
• Medical writers starting out in a healthcare communications and/or advertising agency

Objectives

Hundreds of thousands of words and pages are dedicated to the process of getting pharmaceutical products tested, approved and in the hands of doctors. Near the end of this process, you will find marketers. The people who are working to get these products prescribed for patients. Participants in this workshop will gain understanding about what goes on behind the scenes in pharmaceutical marketing and the role of the medical writer, learn about the wide variety of materials produced at this stage, and be equipped to communicate appropriate effective, consistent selling messages across media.

Content

The objective of the workshop will be achieved by providing participants with an overview of medical communications and where marketing and promotion fits into the bigger picture, going through the basic structure of agencies that work in this field and the role of the medical writer, covering the profile of clients and the end audience, clarifying the difference between pre- and post-launch materials, detailing the types of materials to be created and the regulations that guide pharmaceutical promotions. We will also get into the creative side of things by learning how to craft effective messages that fit into the limitations of what can and cannot be said based on science, ethics and available data. We will conclude by summarising the keys to becoming a successful medical writer in the field of promotional marketing.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

DDF21

Participant Profile

Medical writers who want to know more about quality aspects relating to Clinical Study Report (CSR) development.

Objectives

To provide an introduction to quality awareness in CSR development.

Content

The workshop will explain:
- the important differences between quality assurance and quality control
- the audit process – what we do and don’t do in CSR audits
- common audit observations relating to CSRs
- quality considerations for the CSR process – timelines, documents to provide pre-audit, how to respond to audit findings, audit follow up, and corrective and preventative actions (CAPAs)
- SOP requirements for CSR preparation, review and approval

Workshop participants should be aware that the format is that of a presentation with opportunity provided for questions, answers and discussion. There will be two short interactive exercises to complete during the workshop.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

MCF17
Using Writing Guidelines for Manuscripts
Medical Communication - Foundation

Participant Profile

This workshop is aimed at any scientific writer working for scientific journals or congresses.

Objectives

The growing availability of guidelines and checklists makes identification and use of the most appropriate guideline for any specific disclosure more difficult. This workshop will help the writer to identify what is available and understand how to choose the most appropriate guidelines for their purpose.

Content

The Consolidated Standards of Reporting Trials (CONSORT) statement, issued in 2001, was the first example of a comprehensive and structured guideline on how to communicate the results of randomised clinical trials. In addition, different guidelines and checklists to use for the results of observational, health outcome, quality of life, mixed-method, and many other types of studies have been published. To complement all of these, pharmaceutical companies have developed Good Publication Practice, individual editors have developed their own guidelines, and most journals have their own instructions for authors. In this workshop we will review the main guidelines to identify when and how they can be used by medical writers to improve the productivity and quality of their job.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:00hrs

10:15
to
11:00

Refreshment break
11:45
to
13:15

Lunch

Content

As of 21 July 2014, it will become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by the European Medicines Agency (EMA). This date corresponds to the finalisation of the programming of the database as referred to in a European Commission guideline [1], in application of the current clinical trials Directive 2001/20/EC [2], and the Paediatric Regulation, comprised of two documents [3]. Under these frameworks, since the result-related information is fed into the publicly accessible European Union Clinical Trials Register clinical trial database (EudraCT), summary results of clinical trials performed with European Union (EU)-approved and unapproved drugs will become available to the public as sponsors start to comply with their legal obligations. The current presentation will builds up on the summary document that was prepared by EMWA in 2014 [4] and will update on what these legal obligations mean for the sponsors of clinical studies and in particular for the medical writers. A brief information will be provided on the proposed Policy 0070 regarding disclosure of individual participant data from clinical trials performed with EU-approved drugs [5].
1) Commission Guideline — Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006 ; (2012/C 302/03). http://ec.europa.eu/health/files/eudralex/vol-10/2012_302-03/2012_302-03_en.pdf
2) Directive 2001/20/EC of the European parliament and of the council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF
3) Paediatric Regulation: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf; and http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1902/reg_2006_1902_en.pdf
4) Transparency of Clinical Trial Data – Where Does Medical Writing Fit In? Report on the 2nd European Medical Writers Association Symposium. EMWA Budapest 2014 http://www.emwa.org/Documents/Transparency%20Symposium%20Budapest%20Final.pdf
5) European Medicines Agency policy on publication of clinical data for medicinal products for human use. 2014
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf
13:30
to
16:30

LWF9
Summarising
Language and Writing - Foundation

Participant Profile

This workshop is intended for medical writers who work mostly on regulatory documents. Participants should have a basic knowledge of the most common regulatory documents (e.g. clinical study reports, protocols, and investigator’s brochures).

Objectives

Medical writers spend most of their time summarising information. The purpose of the workshop is to provide a structured approach to identifying key information so that they can prepare a summary of any regulatory document that meets the needs of the reader and includes appropriate information.

Content

The workshop will start by clarifying what is meant by summarising and the summary documents that we produce. Identifying key messages will be discussed and this will help us to decide what to leave out. Some general guidance will be given on concise writing and on planning the document. The importance of review and revision will be described and discussed, and we will work on reducing the number of words needed to express a point. Workshop exercises will be used to illustrate the points raised and to give participants the opportunity to practise the methods suggested during the workshop.

Pre-Workshop Assignment Length: 0:30hrs

Post-Workshop Assignment Length: 3:00hrs

Participant Profile

Mindfulness is a way of paying attention, on purpose and non-judgementally, to what goes on in the present moment in our bodies, our minds, and in the world around us. Mindfulness-Based Stress Reduction (MBSR) is the largest and best-known stress reduction programme in the world which has been embraced by many large corporations and educational institutions. MBSR is recommended by the National Institute for Health and Clinical Excellence in the UK and has been shown to be effective treatment for a wide range of medical disorders, as well as improving quality of life in healthy individuals. Recent studies have shown that taking time to do mindfulness meditation at work can improve concentration and productivity.

There are many techniques that can help us to learn to be mindful. These include ‘meditating’ (i.e. focusing) on the breath, our body, or on any activity that we are doing. We will practice a few simple techniques during the seminar so that participants can experience how it feels to be mindful.

We will encourage the participants to share their experiences, challenges, and stresses of working as medical writers. We will then investigate how mindfulness techniques could help in these situations so that work becomes more enjoyable even when deadlines are looming.

Numerous clinical trials that have been performed on the effects of mindfulness in healthy volunteers and on various diseases. The seminar will include an up-to-date literature review of the scientific evidence for the positive effects of mindfulness on our physical and mental health.
13:30
to
17:00

MCF8a
From Clinical Study Report to Manuscript
Medical Communication - Foundation

Participant Profile

Medical writers who write or expect to write manuscripts based on Clinical Study Reports (CSRs). Participants ideally should have already attended the EMWA workshops on ‘Writing a Clinical Study Report Using ICH E3’ and ‘Writing a Manuscript for Publication’, or should have equivalent experience in at least one of these areas of medical writing.

Objectives

To acquire effective strategies and techniques to write a manuscript for publication based on a CSR.

Content

• Examine differences between CSRs and manuscripts (pre-workshop assignment)
• Prepare a document checklist for writing a manuscript from a CSR
• Discuss timelines and review cycles for manuscript writing
• Determine which sections of a CSR (ICH E3) are relevant for a manuscript
• Establish guidelines for writing a manuscript based on a CSR
• Analyse examples of CSR text and convert to manuscript format (post-workshop assignment)

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

DDA18a
Medical Writing for Healthy Volunteer Studies
Drug Development - Advanced

Participant Profile

This workshop is for medical writers who would like to learn more about writing the documents needed for clinical trials conducted with healthy volunteers rather than patients (such as Phase 1, thorough QT, and bioequivalence studies). Participants should have basic knowledge of healthy volunteer study objectives and design (participants who do not have this knowledge should first take Workshop DDF39 An Overview of Healthy Volunteer Studies) and some experience in writing key clinical trial documents (informed consent forms, protocols, clinical study reports, lay summaries).

Objectives

Healthy volunteer studies make up a large proportion of studies in most clinical development programmes. Medical writers need to understand how these studies differ from clinical trials in patients and how the differences affect the documents required for these studies. After attending this workshop, the participant will understand the unique structural and content requirements of documents related to healthy volunteer studies.

Content

This workshop will cover the following topics for healthy volunteer studies:
• Key regulatory guidance documents
• Protocols
• Informed consent forms
• Clinical study reports
• Lay summaries
Note: Phase I studies in patients will not be covered.Note: This workshop has been revised to give more time to focus on writing the documents needed for clinical trials conducted with healthy volunteers.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

PTA10
Effective Reporting of Scales, Questionnaires and VAS
Professional Techniques - Advanced

Participant Profile

This workshop addresses writers dealing with or interested in areas of clinical research, such as psychiatry, pain, quality of life, or health outcomes, where “soft” endpoints are often used to assess treatments. Participants should have at least 1 year of medical writing experience and should already have written a study report or a manuscript based on the results of clinical studies.

Objectives

This workshop explains the use of assessments in treatment outcomes that cannot easily be measured objectively. Typical examples are patient or physician questionnaires and visual analogue scales. These are often used in psychiatry, pain studies, or quality of life research where objective measurements are not possible or difficult. The reporting of these “soft endpoints” has some pitfalls, often providing a huge amount of data that is difficult to analyze and interpret. Given the growing importance of psychiatry and quality of life research, scales and questionnaires are becoming more and more important for medical writers.

Content

Why are “soft endpoints” used in clinical research? What are typical examples of questionnaires? How should the measurements be selected (validation, generic vs. specific measures, acceptance)? How can results be evaluated and interpreted, including calculation of scores and subscores, and frequently used statistical analyses? How can results be communicated effectively without overwhelming the reader by the sheer amount of data? What needs to be taken into account when interpreting and discussing the results of questionnaires?

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

DDA20

Participant Profile

Aimed at medical writers with some experience of writing risk management plans (RMPs) or other safety documents (e.g. Periodic Safety Update Reports), or who have attended the foundation workshop on RMPs (the latter may be helpful for those with no experience of RMPs). Participants may also find the workshop “Introduction to Pharmacovigilance writing” (DDF32) helpful.

Objectives

To learn about the regulatory requirements and the main changes introduced by the revision of the RMP guidance and template (expected in January 2017). At the end of the workshop, participants will be able to identify the right format and content for each section and deal with some major challenges of the new RMP format.

Content

This workshop will provide an overview of the changes introduced by the revision of the Good Pharmacovigilance Practice (GVP) module V on Risk Management Systems, particularly focusing on the RMP format.Participants will learn how to choose the right format for RMPs in different scenarios. A brief overview of the structure and contents of the RMP according to the revised GVP Module V will be provided. Major challenges of the new format will be explored in exercises. Particular emphasis will be given to the new definition of important risks, to common pitfalls when updating existing RMPs written in the old format, and to the summary of the RMP for the lay public.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

Participant Profile

This basic workshop is intended for participants directly or indirectly involved in the planning, analysis and/or reporting of clinical trials, or in the design of clinical development programs, or those with little or no background in this area who are interested in learning the basics.
Previous experience or background knowledge of clinical trial disclosure is not required.
This workshop will benefit newcomers to the topic, but also those simply wishing to update their knowledge of this topic.

Objectives

Upon completion of the workshop, the participants will understand the regulatory requirements (e.g., EMA Policies 043 and 070) and industry commitments for clinical trial disclosure, understand how patients and investigational sites may benefit from this clinical trial disclosure, be introduced to the new documents required due to clinical trial disclosure (EMA Policy 070 anonymisation report, lay summaries, etc.), and be aware of the challenges created by clinical trial disclosure for when drafting clinical documents (e.g., protocols, clinical study reports) for use during clinical development.

Content

This will be an interactive workshop combining classical presentations with quizzes and exercises to introduce the topic. The aspects of clinical trial disclosure most relevant for medical writers, including potential new deliverables and challenges during protocol and CSR writing, will be highlighted. This workshop will enable attendee to embark upon workshops covering specialized topics such as the drafting of lay summaries, trial registration and results reporting in EudraCT/clinicaltrials.gov, and the protection of protected personal data and commercially confidential data.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:00hrs

13:30
to
17:00

DDA2b

Participant Profile

Medical writers with knowledge of MAA or NDA preparation who are interested in expanding their knowledge of authority review processes and the role of medical writing after dossier submission in Europe and the US.

Objectives

While the Common Technical Document harmonises the structure of regulatory documents submitted to the European EMA and the US FDA for marketing approval, the review processes leading to the decision on whether to approve or not still differ markedly between the two authorities. In both cases, though, the demand for medical writing skills in the broadest sense (linguistic, scientific, organisational, diplomatic) can be high. The objective of this workshop is to familiarise participants with the post–submission review processes of these two authorities and illustrate the pivotal role medical writers can play in helping to optimise a sponsor’s chances for obtaining a successful drug approval.

Content

The workshop will navigate you through the post–submission review processes you can expect to encounter, and through the numerous medical writing activities that can arise during EMA and FDA reviews of a submission dossier (e.g., drafting responses to the authority’s questions, preparing safety updates and NDA amendments, writing briefing documents, organising and preparing presentation materials for CHMP Oral Explanations and FDA Advisory Committee meetings). The workshop illustrates salient points and potential pitfalls by recalling personal experiences working on a European–US approval team. The workshop exercise focuses on how FDA and sponsor can differ in their interpretations of the same data, which will give participants some insight into the FDA Advisory Committee hearing process and into the preparations that need to be made for it by the sponsor.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

LWA14

Participant Profile

This workshop is at an advanced level, but is accessible to all medical writers interested in the journal article.

Objectives

This workshop is designed to enhance understanding the writing distractions pertinent to conceptual components of the journal article. The distractions are syntactic (structure, order, number, grammar, punctuation, paragraph) of words, phrases, and clauses.

Content

You will test the clarity and appropriateness of many syntactic options, beginning in the pre-workshop exercise and continuing in the workshop discussion. We will use a clarity-testing option approach, whereby you will decide between two sentence options—one with a presumed distraction and the other with a revision. In the workshop, participants will justify their selections; the workshop leader will reveal the tally of the individual selections and will discuss their taxonomic analysis. For the post-workshop assignment you will receive another set of options that test those principles of clarity and appropriateness that were determined during the workshop to be controversial.

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
17:00

MCA3a
Systematic Reviews
Medical Communication - Advanced

Participant Profile

The workshop was developed for medical writers with little or no experience in preparing systematic literature reviews of clinical studies. Participants should have a good understanding of study design in clinical research as well as of analysis and presentation of data from clinical studies.

Objectives

The objective of the workshop is to give an overview of the purpose of systematic reviews of clinical studies and of the methods and processes used to develop these reviews. After the workshop, participants will be familiar with the requirements for publication of systematic reviews and will understand how to evaluate the quality of systematic literature reviews of clinical research.

Content

The workshop will discuss the following topics:
• Purpose of systematic literature reviews of clinical studies
• Definition and characteristics of systematic reviews
• Methods of developing a review
• Writing a publication on a systematic review

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

14:15
to
15:00

Refreshment break
17:15
to
18:15

Objectives

It has been 10 years since the first approval of biosimilars but as the use of these products in Europe continues to grow, unique challenges remain.  Medical writers need to understand the  processes for the development and approval of biosimilars in Europe, and the current opportunities and challenges in this field. This seminar will provide a basic understanding of the clinical development and regulatory pathways for biosimilars, provide guidance on interpreting clinical data for biosimilars, and touch on some current hot topics including automatic substitution and extrapolation.

Content

This workshop will consist of a mixture of lecture and interactive elements. The following topics will be covered:
1.       EMA definition of a biosimilar
2.       Why biosimilars matter
3.       The development process: Originator vs. biosimilar
4.       Demonstrating biosimilarity: From characterization studies to clinical confirmation of similarity
5.       Regulatory guidance in Europe: naming, substitution and extrapolation
6.       How to  provide information to prescribers and patients to enable informed, shared treatment decisions
19:30
to
23:30

Tour options
Social

Saturday 06 May

08:45
to
11:45

PTF26
Medical Information: an Opportunity for Medical Writers
Professional Techniques - Foundation

Participant Profile

This workshop is designed to increase awareness and knowledge of Medical Information within the pharmaceutical industry, providing Medical Writers an alternative option in their Medical Writing career. Whilst no prerequisites workshops are required, participants are expected to have a basic understanding in drug development, dealing with US and EU regulations and medical education.

Objectives

This workshop will provide participants an insight to how Medical Writers are contributing to Medical Information departments across the globe; including the creation and maintenance of medical standard responses, dealing with new data releases at congresses, and the overall distribution of Medical Content to key stakeholders. Participants will be able to evaluate how their existing writing skills can be transferred when creating medical content for healthcare professionals.
This workshop will deliver an alternative option to Regulatory Writing and Medical Communications, a much needed option for those participants wishing to increase their development in Medical Writing.


This workshop will deliver an alternative option to Regulatory Writing and Medical Communications, a much needed option for those participants wishing to increase their development in Medical Writing.

Content

The objectives will be achieved by providing an introduction to Medical Information, and the purpose of such departments existing in institutions whereby drug development occurs. Further, the workshop will consider the structure of Medical Information – Global and Local markets – and the natural flow of medical content, touching on US and EU regulations. Much of the workshop will focus on medical content, and how multiple forms of communications are employed to educate customers on a particular product (medical standard responses, slide decks etc.) in a non-promotional manner. Simultaneously, the workshop will illustrate the role played by Medical Writers from writing responses to creating slide decks, as well as becoming specialists in a particular therapy area and/or products.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

MSF6

Participant Profile

Participants should, ideally, have already completed Introduction to Pharmacokinetics (DDF7) and Pharmacology for Medical Writers: Part 1 – The Basics (MSF1), or have equivalent experience or knowledge.

Objectives

This workshop is designed to explain the reasons behind the commonest types of adverse effects of drugs and medicines. This is intended to enable participants to understand and often predict adverse effects of new drugs and medicines. This will make it easier for participants to write accurately and effectively about the adverse effects of the drugs and medicines they will meet in their work.

Content

All effective drugs (and hence the medicines that contain them) have adverse effects. To be useful, therefore, the effective (i.e. therapeutic) dose of a drug or medicine must produce only acceptable adverse effects. Adverse effects can arise in several ways, and this workshop seeks to describe these in a systematic way. The mechanisms can be broadly summarised as follows:
(1) Extended normal pharmacology
(2) Parallel pharmacology
(3) Idiosyncratic reaction
(4) Pharmaceutical
(5) Pharmacokinetic interaction
(6) Pharmacological interaction
(7) Chemical interaction

Each of these mechanisms will be described with suitable examples, and the clinical significance of the different types of interaction will be discussed. Because of its largely factual content, the workshop will be mainly didactic. However, attendees will be expected to participate by answering questions as the presenter develops the explanations.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

PTF18a
Writing for the Internet
Professional Techniques - Foundation

Participant Profile

This workshop is suitable for any medical writer with an interest in writing for the internet, whether already involved in this type of writing or not.

Objectives

Medical writers are increasingly asked to provide text for online use. The objective of this workshop is to outline the basic principles of writing for the internet. The emphasis will be on understanding how online content differs to more traditional media. We will NOT cover technical aspects of website design, style sheets, coding, hosting, and related issues.

Content

We will review the basic principles of writing for the internet and consider how it differs from writing for print. We will also think about how readers use the internet, and the visual and structural aspects of presenting information online. We will examine different online writing structures such as the inverted pyramid technique. The importance of headings and sub-headings are also outlined. Other topics such as Search Engine Optimisation (SEO), metadata and calls to action will also be briefly covered. The workshop will include practical exercises on creating internet text. A selection of post-workshop assignments will be published on the EMWA website!

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

PTF22
Managing the Clinical Study Protocol Writing Process
Professional Techniques - Foundation

Participant Profile

This workshop is aimed at staff and freelance medical writers who are interested in learning how they can make an effective contribution to the protocol writing process by taking a leading role. Previous participation in the workshop on The Clinical Study Protocol is recommended.

Objectives

The objective of this workshop is to present the process of study protocol preparation to medical writers as a type of project management. The emphasis will be on the process of how the medical writer can effectively lead the preparation, review, and finalization of a clinical study protocol as a member of a multifunctional team. Study protocol writing will not be discussed in detail.
Upon completion of this workshop, participants should be better prepared to work efficiently within a complex and at times quickly changing environment

Content

The workshop will cover the role of the medical writer in leading the protocol writing process as a member of a multifunctional team.
Best practices (do’s and don’ts) will be covered showing how a medical writer can best lead the team through the different steps in the process (from the kick-off meeting with the study team to the finalisation of the document).. Useful tools and practical approaches that can make the process easier will be presented.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
11:45

PTA12
Interpersonal Skills for Medical Writers
Professional Techniques - Advanced

Participant Profile

Anyone who wants to explore effective and diplomatic ways of overcoming common interpersonal hurdles that arise in the course of every day life as a medical writer.

Objectives

To think about the role of the medical writer as a team mediator and to learn how to solve common interpersonal problems, either by avoiding them in advance or by understanding the issues that need to be addressed once they have occurred.

Content

As medical writers, we deal with many different people (some with very large egos and very little diplomacy) to prepare the documentation we are expected to write. This workshop will present and discuss the basic philosophy of the role of a medical writer in the social context. We will look at our role on a project team in terms of team dynamics as well as how we interact with people on a one-on-one basis. Real-life examples (good and bad) and hands-on exercises followed by discussion will demonstrate how to use different approaches in different contexts to minimize interpersonal conflicts and overcome those that occur.

Pre-Workshop Assignment Length: hrs

Post-Workshop Assignment Length: hrs

08:45
to
11:45

DDF13

Participant Profile

This workshop is aimed at writers who wish to learn about the concepts underlying clinical development (e.g. the standard sections of a study protocol aimed at proving efficacy or the literature on clinical trials of efficacy). The workshop is suitable for those setting out to write regulatory documents as well as those who already have experience in medical communications or medical publishing who wish to understand the concepts underlying experimental study design.

Objectives

To raise basic understanding of both study design and study conduct issues and the importance of these for valid and relevant experiments in trials intended as confirmatory studies of efficacy.

Content

This workshop focuses on the theoretical concepts underlying good design and not the process of either protocol or report generation, nor the wider content of these documents.

The following topics are covered:
• The design characteristics of a confirmatory study of efficacy
• The relationship between the study objective, the study hypotheses, the choice of endpoint and choice of control group
• Factors governing the identification of the study population
• The basis of sample size and its relationship with ‘power’
• Robustness of data based on the example of the full analysis set (also known as ITT) and a per protocol analysis set
• Bias: blinding and randomising to treatment groups and identifying bias in data
• The relationship between statistical significance, clinical relevance and ‘generalisability’

There will be classroom-format presentations as well as group exercises. The approach is intuitive, not statistical.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

MCF5

Participant Profile

This workshop will benefit medical writers who want to know more about publishing articles in biomedical journals or who have encountered issues with journals.

Objectives

Publishing an article is becoming increasingly complicated as biomedical journals constantly develop and change their policies and working procedures—added to which the whole process is hampered by a shroud of mystery and inconsistency between journals. This workshop focuses on avoiding common pitfalls in writing, presenting and submitting manuscripts. It also gives tips on how to locate and keep abreast of journal policies and develop an effective relationship with editorial offices. After completing the workshop, participants will be armed with a better understanding of biomedical journals, their requirements and foibles. They will have the confidence to steer their manuscripts to successful publication in the shortest time possible with the least hassle.

Content

Previous title: Marketing your Manuscript and Dealing with Biomedical Journals

Participants are encouraged to highlight areas of concern for discussion and share the issues they have encountered. The workshop will cover:

• Keeping on track: policy and procedure sources, keeping up with changes

• Choosing the best journal: beyond looking at scope

• Avoiding common pitfalls in the manuscript preparation and submission process

• Adherence to reporting guidelines

• Effective communication with editorial offices: presubmission enquiries, speeding up review, dealing with reviewers’ comments, appeals against rejection

• Editors’ approaches to authors’ concerns: quality of reviews, authorship, abuse of privilege

• Editors’ concerns: conflicts of interest, plagiarism, duplicate publication, data splitting, data access

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

Participant Profile

This workshop is for medical writers at different stages of their career. There is no prerequisite in order to participate but a basic knowledge of clinical trial documents is expected.

Objectives

The EMA Policy 0070 and the accompanying guidance entail finding the right balance between disclosure of clinical trial (CT) data and protection of patient privacy. The objective of this workshop is to help medical writers deal with different documents impacted by the EMA Policy 0070 with particular focus on clinical trial documents. The participant will gain knowledge in identifying critical patient data and the “risk areas” of a CT document or project and in mitigating risks to patient confidentiality.
The workshop participants will be provided hands-on exercises to
· identify patient data that can lead to de-identification.
· identify the most critical CT documents impacted directly or indirectly by the guidance, as well as the specific sections in these documents that require scrutiny for data protection issues.
· identify the stage in a document life cycle wherein the MW should ideally take a proactive role in identifying the issues.
· come up with strategies to mitigate risks to patient confidentiality.

Content

The workshop will cover:
· Short introduction to clinical trial disclosure and EMA Policy 0070
· Challenges and risks to patient data protection
· CT documents impacted (with focus on the protocol and the clinical study report)
· The role of medical writers in identifying the “risk” areas of these documents· Data anonymisation techniques at the writing/document level
· Working with other functional groups to ensure patient data protection in CT documents

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

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.

Objectives

• To introduce participants to the preparation of clinical submission dossiers according to the CTD• To convey general principles and process of summary writing
• To facilitate understanding of the limits of the available regulatory guidance

Content

• Development and background of the CTD
• Purpose and types of clinical summary documents
• CTD Module 2.5 (Clinical Overview)
• CTD Module 2.7 (Clinical Summary)
• Integrated summaries of efficacy and safety for the USA

Pre-Workshop Assignment Length: 4:00hrs

Post-Workshop Assignment Length: 4:00hrs

09:00
to
12:00

Introduction to Medical Writing
Seminar - Not for credit

Participant Profile

This seminar is provided free-of-charge and is aimed at those considering a career in medical writing. It is open to conference delegates and members of the general public. It will also be interesting to those who have recently joined the profession who would like to know more.

Content

In addition to giving a presentation covering all aspects of medical writing, the seminar leader will act as a facilitator to optimise exchange of experience between participants, as well as providing insight based on her expertise in this area.

The aim is to provide information on the following:

• Definition of medical writing and its different categories
• Role of the medical writer throughout the life-cycle of a pharmaceutical product
• Explanation of the different types of documents that we write with detailed information on some of the most common (e.g. clinical study protocols and reports, investigator brochures, CTDs, manuscripts, posters)
• Timelines and project management
• Finding a job as a medical writer (qualities and qualifications required), types of companies that employ medical writers, recruitment process, working as a freelancer
• Training and networking for medical writers

Members of the public who wish to attend the seminar should approach the EMWA Staff at the Conference registration desk who will issue them with a temporary badge and direct them to the seminar room.
10:15
to
11:00

Refreshment break
11:45
to
13:15

Lunch