Programme

46th EMWA Conference - Barcelona

1 - 5 May 2018

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.

 

Click here to see room allocations

 

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Tuesday 1 May

16:00
to
20:00

Registration

Content

Welcome from the EMWA President and Conference Director, presentation of awards, and opening lectures by Art Gertel and Juan Torrent

17:00 Treatment of peritoneal carcinomatosis. Juan Torrent.

Peritoneal carcinomatosis is a tumoral dissemination from different cancer origins inside the abdominal cavity. Most common types are from colorectal, gastric and ovarian cancer.
Natural history studies show that peritoneal carcinomatosis is fatal with median survival ranging from 6 to 24 months when treating the patients with the best chemotherapies.
For more than 2 decades, a handful of centers have pursued agressive cytoreductive surgery with or without hyperthermic intraperitoneal intraoperative chemotherapy (HIPEC) as an alternative approach to this disease, with favorable results in survival rates, close to 60 months.
Agressive surgery +/- HIPEC should be the standard treatment to treat peritoneal carcinomatosis.


17:40 Shackleton’s Ghost Writer — Are Authorship Standards Always Important? Art Gertel

Many of us have read and enjoyed popular literature, without giving a second thought to issues of authorship. As professional medical writers, we are acutely aware of the guidelines and standards that govern authorship of medical and scientific documents and manuscripts. Using the historical drama of Sir Ernest Shackleton’s Endurance voyage, Art Gertel will juxtapose authorship criteria between popular and scientific/medical literature. Please join him on this journey, and come away with a taste for adventure!

18:20 Barcelona's hidden places. Juan Torrent. 

18:45 Presentation of awards
19:00
to
21:00

Networking Reception
Social

Wednesday 2 May

07:00
to
07:30

Easy morning yoga session
Drop-in Session

Content

From natural catastrophes to terrorist acts to cyber attacks – serious threats to business continuity are ever more present in our environment. Ensuring readiness to respond to an unpredicted and unprecedented interruption of “business as usual” requires planning and practice. This presentation will address considerations for disaster preparedness and include lessons learned from an actual experience of cyber breach as a platform to stimulate discussion among participants.
08:45
to
11:45

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
11:45

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

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
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
11:45

MCF23
Congress Coverage
Medical Communication - Foundation

Participant Profile

Medical writers working in the pharmaceutical, biotech, healthcare or other related industries who would like to know more about the best practices for medical congress coverage. There are no prerequisites for the workshop.

Objectives

Some of the most common research deliverables (i.e. abstracts, posters, and slide decks) are presented throughout the year at scientific congresses. Although medical writers can produce these documents, they may also need to attend the congress and develop a congress coverage report. Participants in this workshop will gain an understanding of how to develop key resources before arriving onsite, how to use technology to their advantage at the meeting, and how to capture key messages in their reports.

Content

The workshop will begin with the basics of scientific congresses and consider all aspects of preparation, including pre-congress planning, project management, logistics, and best practices. We will then examine the use of technologies and apps to facilitate gathering information. Finally, the different types/styles of congress reports will be explained.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

DDF7
Introduction to Pharmacokinetics
Drug Development - Foundation

Participant Profile

This workshop is aimed at medical writers, both new and experienced, who need to understand the basics of pharmacokinetics. Participants will normally have had little if any previous formal instruction in pharmacokinetics, or may not have understood what instruction they have received (or may even have received such instruction before they realised they would need it).

Objectives

The objective of this workshop is to demystify pharmacokinetics for those who are terrified of mathematics. On completing the workshop participants should understand the meanings of some of the key terms and symbols used in pharmacokinetics, have some understanding of what the different terms tell us about the properties of drugs and be able to write competently about basic pharmacokinetics.

Content

Participants will be given straightforward explanations and derivations of the key pharmacokinetic principles and equations. These explanations will be largely conceptual rather than mathematical, with worrisome mathematical terms and techniques explained in simple terms.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

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 as well as 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. The workshop leader sees herself primarily as a facilitator and guide in achieving results. That is to say there will be almost no lecture content. Based on examples provided by the workshop leader, participants will work together in small groups to improve a text after which feedback will be provided all together. This workshop demands team work and your active participation. Obviously, therefore, it is necessary that you yourself are a confident speaker of English. 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 feedback 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

DDA15a
Development Safety Update Reports
Drug Development - Advanced

Participant Profile

This workshop is aimed at medical writers with little or no experience of writing a Development Safety Update Report (DSUR). Participants should have some experience of collection of safety data, analysis of safety data, and a basic understanding of safety monitoring during clinical trials.
Participation in DDF32 - Introduction to Pharmacovigilance Writing would also help writers with little or no experience.

Objectives

The regulatory authorities in the ICH regions require submission of annual safety reports during a clinical trial and medical writers are increasingly being asked to prepare these reports. ICH E2F introduced the DSUR format in 2011 as a harmonized format for annual safety reports. The aim of this workshop is to explain what the DSUR is, when it needs to be produced, which data to include, how to present them, and project management of stakeholder parties involved.

Content

The workshop will give a brief overview of pharmacovigilance during the clinical trial, including the role of the annual safety report, and the need for a harmonized report format. Practical experience gained since the implementation of the DSUR in Autumn 2011 will be used to help writers prepare for the different DSUR sections.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

PTA13
The Art of Mentoring
Professional Techniques - Advanced

Participant Profile

Participants who already mentor other writers or those who may soon be given the role will benefit from this workshop, including those who take on the role voluntarily and those who are more hesitant about their abilities. Most participants will have been medical writing for at least 2-3 years and will have a good foundation in their chosen career path.

Complementary workshops: PTA11 – Strategies for Improving Document Quality and PTA12 – Interpersonal Skills for Medical Writers.

Objectives

The aim of this workshop is to give both new and experienced mentors an open and encouraging environment for learning, developing and sharing mentoring skills. The workshop has been devised to inspire and enthuse participants in what is at times a challenging, yet highly rewarding role. After completion of the workshop and class exercises, participants should have a raised awareness of their role as mentors and the impact they may have on their mentees, teams and product quality. The workshop will also discuss strategies to diplomatically manage the varied situations that mentors may encounter.

Content

This workshop will cover how mentoring can add significant value to teams and drive improvements in product quality; how to mentor in a holistic manner; how to vary mentoring style according to different mentee personalities; how to allow mentees to develop individually; and how to learn from mentees and develop personally through the mentoring role. Setting up and coordinating mentoring systems is outside the scope of this workshop.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:30hrs

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

10:00
to
10:45

Refreshment break
11:45
to
13:15

Lunch
12:45
to
13:15

PV Roundtable discussion
Not for credit

Content

The PV SIG will be holding a table discussion during the lunch break. The relevant tables will be sign posted in the lunch area.

Content

See ESS page for further details
13:30
to
16:30

PTF23
Subgroup Analysis
Professional Techniques - Foundation

Participant Profile

This workshop is targeted at medical writers who are aware of clinical studies, protocols, and clinical study reports.

Objectives

The objective of this workshop is to understand the concept of subgroup analysis in clinical studies, and how to appropriately apply it to protocol and clinical study report writing. This workshop will also familiarise participants with the current European Medicines Agency (EMA) regulations on subgroups.

Content

This workshop will cover the importance of subgroup analysis, based on the current EMA regulations, and the associated limitations. This workshop will illustrate the implications of inappropriate emphasis on subgroup findings, the implications of false-positives and false-negatives when making claims on the efficacy and safety of drugs, and discuss the considerations for protocol and clinical study report writing.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
16:30

DDF32a
Introduction to Pharmacovigilance Writing
Drug Development - Foundation

Participant Profile

Writers who want to better understand the different types of pharmacovigilance (PV) documents, when and why they are needed and how they interact with each other. It is recommended that this workshop is completed before attending the advanced workshops for writing Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and Periodic Benefit-Risk Evaluation Reports (PBRER).

Objectives

After completing this workshop, participants will have basic understanding of the different PV documents required by the regulatory authorities both prior to marketing and post-marketing. They will understand the purpose of the documents, when they are required, how they interact and overlap with each other and what guidance is available to help in preparation of them. In addition, they will be introduced to the difference of the safety data collected in clinical trials and post-marketing.

Content

In depth document content and format is covered in other document-specific workshops. This workshop will provide a basic overview of RMP, DSUR and PBRER, and explain the standard terms and definitions routinely used in PV documents. It will discuss overlaps and links between these documents, available guidance, when and why the documents are needed, who uses them, and what the roles medical writers in clinical development and PV have in developing the documents.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

Participant Profile

This workshop is intended for writers or editors who already work on different aspects of company-sponsored symposia, such as slide preparation, or those who might wish to get involved with their organisation in the future.

Objectives

Company-sponsored symposia (e.g. satellite symposia) are complex events and the medical writer might be involved, not just in developing content or preparing outputs, but also 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 introduce the participants 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

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 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

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

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 identification, analysis, and revision of writing distractions.

Content

Do you want to gain insight into your medical writing syntactic distractions—insight that will enhance your syntactic fluency?
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 analyse and 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: Respond to the workshop-identified distractions in your 5-revised sentences.

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
17:00

MCF1a
Introduction to Manuscript Writing
Medical Communication - Foundation

Participant Profile

This workshop is intended for medical writers who have little or no experience in writing peer-reviewed manuscripts. No prior experience in manuscript writing is necessary.

Objectives

The goal of the workshop is to give medical writers the confidence to begin writing manuscripts and to improve their chances of getting their manuscripts accepted for publication. After completing the workshop, participants should be familiar with the goals, structure, and content of manuscripts destined for peer-reviewed journals; simple steps to take to avoid immediate rejection and improve the chance of getting a manuscript accepted; the step-by-step process of writing a manuscript; how to select data to include in a manuscript; and how to handle the peer review process both practically and emotionally.

Content

This workshop will cover:
• Before you start writing a manuscript: choosing a journal
• Instructions and guidelines for manuscripts
• The parts of the manuscript: what belongs where
• Selecting which data to put in a manuscript
• Common pitfalls and how to avoid them
• Step-by-step instructions for writing a manuscript
• The peer review process and how to learn to love it
• The role of the professional medical writer in manuscript writing

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

Participant Profile

Medical writers with experience in medical communications or regulatory writing. Some experience and understanding of the regulatory requirements for the market approval of medicinal products is expected.

Objectives

To introduce the field of medical devices and associated document requirements. Areas covered include: classification of medical devices, basic regulatory issues regarding the approval and marketing of medical devices, recent changes in regulatory requirements and how these impact the medical writer’s role, as well as some of the most common medical communication documents.

Content

A syringe, a knee prosthesis, a computerised tomography (CT) scanner, an external defibrillator, and a pacemaker are all medical devices, but they belong to different risk classes. The new regulations (MEDEV rev. 4 and Medical Device Regulation) define a core documentation set required for regulatory compliance of these devices. And this can be challenging for the industry and the medical writer.

Focusing on a set of different medical devices, the main elements of the workshop will introduce:

• What is a medical device and why and how they are classified
• Key documentation for regulatory compliance and market release of a medical device
• Medical communication texts: particularities for medical devices

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: 2:30hrs

13:30
to
17:00

PTA3c
Slippery Slopes: Survival Analysis
Professional Techniques - Advanced

Participant Profile

The workshop is for everybody who has come into contact with the statistical technique of Kaplan-Meier survival analysis and who wants to know more about what it means. Ideally you should have encountered such analyses in the context of clinical trials.
Some minimal statistical understanding is needed and terms like ‘median’, ‘mean’, ‘confidence interval’, ‘risk’ , and ‘p-value’ should not terrify you.

Objectives

The objective is to acquire a basic understanding of Kaplan-Meier analyses and to be able to interpret the resulting graphs.

Content

The workshop will give participants an understanding of the analysis of survival in the context of clinical trials. We will learn the basics of creating and interpreting Kaplan-Meier graphs and the different elements of reporting Kaplan-Meier analyses. The appropriate graphical and tabular presentation of these analyses will be discussed, but always the focus will be on the interpretation. There will be a few group exercises during the course.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

15:00
to
15:45

Refreshment break
17:15
to
19:00

Annual Meeting
19:30
to
22:30

Dinner with friends
Social

Thursday 3 May

07:00
to
07:30

Easy morning yoga session
Drop-in Session
08:45
to
11:45

PTF13
Critical Appraisal of Medical Literature
Professional Techniques - Foundation

Participant Profile

This workshop will be of use to all medical writers who need to read published medical papers and interpret their findings. Participants should have a basic grasp of trial design (parallel groups, crossovers, etc.) and recognition of (but not necessarily practical experience of using) common statistical tests (e.g. chi-squared, t-test).

Objectives

After attending this workshop, participants should be able to assess the strengths and weaknesses of papers they read in the medical literature and be able to judge whether the published conclusions of the paper are valid.

Content

The workshop will explain what to look for when reading published papers, with emphasis on assessing strengths and weaknesses of the research described. This will include considerations of study design, sources of potential bias, use of appropriate statistical methods, choice of endpoints, and generalisability. The workshop will include practical exercises in critiquing papers in a group discussion format.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

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 increase the likelihood of producing readable research papers with good research questions/purpose statements and well-structured in-depth discussions.

Content

Participants will learn to create a storyline through formulation of a strong purpose statement, to clarify how a study fits into and strengthens the body of knowledge within a field, and to develop logical arguments in the discussion.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
17:00

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

Content

See the Internship forum page for more information.

Content

Please see the Symposium page for full details.
10:00
to
10:45

Refreshment break
11:45
to
13:15

Lunch
13:30
to
16:30

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.
13:30
to
16:30

MSF3

Participant Profile

Medical writers with basic knowledge of descriptive statistics who want to gain insight into the usefulness of epidemiological principles for medical writing.

Objectives

This workshop is designed for medical writers with little to no experience with epidemiology and its applications in the pharmaceutical business and public health. Participants will be provided with a general overview of relevant applications of epidemiology for medical writers. The scope and relevance of contemporary epidemiology for medical writers will be discussed using examples from clinical medicine, public health and pharmacoepidemiology. In addition, commonly used measures of disease occurrence – incidence and prevalence - and their use in research designs will be reviewed. The class format combines lectures with group exercises.

The main objectives are:
• Provide an overview of the applications of epidemiology in the business of medical writing
• Explain the use, significance and pitfalls of commonly used disease frequency indicators: prevalence and incidence

Content

Three major topics will be covered:
• Scope of contemporary epidemiology for medical writers
• Relevance of contemporary epidemiology for medical writers
• Basic measures of epidemiology for medical writers: prevalence and incidence

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 1:00hrs

13:30
to
17:00

PTA6

Participant Profile

Medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers often working to tight protocol and study report writing timelines because of inadequate scheduling of the processes leading up to and driving preparation of these documents. This is an ideal forum for writers whose organisations or clients have scope to improve their analysis and reporting processes and procedures.

Objectives

Protocol writing heralds the start of the trial documentation and reporting process; the study report is often the final document prepared by medical writers. Exacting and sometimes unrealistic timelines for deliverable preparation are often agreed without consultation with the medical writer. The workshop discusses the stages before and during preparation of these documents to show how achievable timelines may be scheduled, thereby facilitating good proposal writing. After completing the workshop, participants will understand the stages involved so they can make a valuable contribution to their organisation’s or client’s process improvement activities and are better equipped to manage client expectations with regard to efficient, effective and realistic proposal writing and project scheduling.

Content

• Bidding and project award process
• First steps on contract win and allocation of study
• Contract review and confirmation of scope
• Communication with client and functional groups
• Scheduling
• Study protocol: stages of preparation
• Clinical study report: stages of preparation
• Proposal writing
• Business advantages of effective scheduling, influencing the process, and managing expectations

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

15:00
to
15:45

Refreshment break
17:15
to
19:00

Freelance Business Forum
Discussion Forum
17:30
to
19:00

EMWA Editorial Board Meeting
Editorial Board Meeting
19:30
to
22:00

Tour options
Social

Friday 4 May

07:00
to
07:30

Easy morning yoga session
Drop-in Session
07:45
to
08:25

English Breakfast Session 1
Short Seminar - Not for credit

Participant Profile

Drop in on this interactive short seminar for a quick ‘English’ fix looking at major and minor issues with the use of English in our context to set you up for the day. Come with questions if you want, but remember we have only 40 minutes. Or send them to me upfront: alistair.reeves@t-online.de

Content

Topics today are:
· Using brackets (parentheses)
· Writing the time
· …..‘ise‘ or …..‘ize‘?
· The suffixes ‘-fold’ and ‘-free’
· Your questions

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.

Content

The ShowIT ShareIT Rise and Shine session on Friday 4th May at 8 am will include:
·         Perfectic editing software with Anne McDonough
·         Backups-dropbox with Adam Jacobs
·         Adobe Indesign with Mariella Franker
·         Readability software- hemingway app with Somsuvro Basu
·         Illustrator with Gabi Plucinska
08:45
to
11:45

MCF19
Medical Writing for Vaccines
Medical Communication - Foundation

Participant Profile

This workshop is intended for medical and scientific writers who are interested in developing clinical and peer-reviewed documents in the specific area of vaccines. Pre-attendance at the Introduction to Vaccines workshop (MSF-10) would be beneficial but is not essential.

Objectives

At the end of this workshop, scientific/medical writers should be able to:
• Correctly use specific vaccine terminology
• Apply specifics of the vaccine field to clinical documents and peer-reviewed publications

Content

The workshop will start with an exercise to identify vaccine-specific terms from a clinical study synopsis. The terms will be discussed and a glossary presented. The specificities of vaccine writing will be explored. After the break, the target audiences for vaccine publications, with respect to journals and meetings will be discussed and an exercise to develop an outline for an introduction will be undertaken.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

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

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

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

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 the actual 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

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

08:45
to
12:15

DDA3
The CTD Clinical Summary
Drug Development - Advanced

Participant Profile

This workshop is aimed at writers with experience in writing clinical study reports but who are new to writing CTD Clinical Summaries.

Objectives

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

Content

The workshop will begin with a brief presentation on what the CTD Clinical Summary is and where it fits in to the overall clinical dossier. This will then be followed by a review of the Clinical Summary structure and the important points within each section. This will then be followed by a review of some example data packages and a group discussion will take place to decide the best way of presenting the data. Finally, there will be a review and summary of the key messages to bear in mind when writing a CTD Clinical Summary.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

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

08:45
to
12:15

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: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

PTF29
How to Manage Your Writing Project
Professional Techniques - Foundation

Participant Profile

This workshop is aimed at writers with limited experience of managing projects and those who need help in ensuring their deliverables meet client expectations and are delivered on time and on budget. The workshop does not cover project management of more complex multifunctional projects. These are covered in the Advanced Workshop “Do More with Less Faster: Project Management for Biomedical Communications”. Other related workshops include “Time Management for Medical Writers”.

Objectives

Apart from writing skills, project management skills are one of the most important skills needed to ensure timely delivery of a quality document. A good writer should take overall ownership of their document during development and drive the writing process forward, ensuring deadlines are met. There are no prerequisites for attendance.
Participants will learn how to plan timelines, determine and confirm roles and responsibilities, arrange effective meetings, communicate effectively and generally ensure that they know exactly what they need to provide, in what format and when.

Content

This workshop covers the basics of managing a writing project. It deals with client expectations, project scope, timelines and costings, planning and management as well as how to identify problems and possible solutions and how to deal with unrealistic requests and timelines. We will look at 3 tools to help with managing projects (effective communication, robust dialogue and effective meetings) and exercises will be included to get delegates to think about creative solutions to problems, how to use robust dialogue techniques and how to ensure you have the information to deliver what is wanted.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

09:00
to
17:00

Executive Committee Meeting
Committee Meeting
10:00
to
10:45

Refreshment break
11:45
to
13:15

Lunch
12:30
to
13:00

RPD SIG update
Seminar - Not for credit
13:30
to
16:30

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).

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
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

Content

See ESS page for further details

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 CT 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.

Content

The workshop will cover:
· a short introduction to CT transparency and 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)
· data anonymisation techniques at the writing/document level
· working with other functional groups to ensure patient data protection in CT documents


The workshop participants will be provided hands-on exercises on how to
· identify patient data that can lead to re-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
· implement anonymisation strategies to mitigate risks to patient confidentiality.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
16:30

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.

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

Participant Profile

The workshop is particularly suited to medical writers who are writing documents entering the public domain. It will be most useful for those who either have no quality control (QC) system in place, or are looking to develop one. For medical writers with greater experience it will provide a forum for discussion and sharing best practice. The workshop content is relevant to those working in a freelance capacity, as well as medical writers employed by CROs, communications agencies, or pharmaceutical companies.

Objectives

For a medical writer whose documents are destined to enter the public domain a QC process is essential. A properly implemented QC process helps reduce errors in the factual presentation of data, and when writing a manuscript ensures an accurate document structure is followed to fulfil a journal’s specific requirements. The workshop will focus on developing a QC process for non-regulatory documents, particularly manuscripts, and detail several strategies to achieve this.

Content

The importance of applying a QC process to documents entering the public domain will be discussed. Methods of implementing the QC process will be outlined and several examples worked through in detail. Although the workshop is applicable to other types of medical writing it will primarily use manuscripts and abstracts as working examples. Regulatory documents (e.g. clinical study reports) will not be covered.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
16:30

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

13:30
to
17:00

MCF17
Using Writing Guidelines for Manuscripts
Medical Communication - Foundation

Participant Profile

As professional medical writers should be reporting guideline champions, this workshop is propaedeutic for any workshops on scientific journals or congresses publishing.

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 and use 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

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

Do you want to gain insight into your medical writing distractions that are specific for the conceptual components of the journal article? If so, the following 3-levels of activities may be for you.
(1) Pre-workshop: Revise the distractions in a set of 5 sentences specific for a conceptual component (e.g., research problem in the Introduction section). Be prepared to discuss the justification for each revision.
(2) Workshop: From a compilation of all the submitted revisions, you (along with a workshop partner) will analyse and vote for the clearest, and then enter a discussion with all registrants as to their decisions. The workshop leader will then justify his decision in terms of an analysis of syntactic distractions for all the revisions. The vote tally monitor will then reveal the votes about which more discussion will be open.
(3) Post-workshop: You will comment on the distractions that may have surfaced in your revisions.
The workshop is a complement to LWA12
Taxonomic Analysis of Medical Writing

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
17:00

LWF15

Participant Profile

This workshop is for medical writers interested in exploring the use of readability tools to help them produce more readable biomedical research text. Participants should have some experience of writing and editing scientific research texts, but do not need specialised knowledge.

Objectives

This workshop explores ‘readability’, focusing on how formulas, formula-derived statistics and other tools can help writers edit biomedical research articles. After this workshop, participants should be able to:
· Understand what determines the readability of a document
· Appreciate what readability formulas measure (usually sentence length and word difficulty) and what formula-derived statistics mean
· Recognise the pros/cons and realistic place of readability statistics, particularly when applying them to biomedical research texts
· Use readability statistics and other tools to screen biomedical texts and help improve text readability.

Content

In this workshop, we will:
· Define ‘readability’ and consider what influences readability
· Consider the importance of readability, particularly of biomedical research articles
· Review commonly-used readability formulas
· Consider the readability of biomedical research articles
· Critically assess the use of readability statistics
· Review other tools available to analyse text and improve readability
· Consider a Readability Screening Checklist.

Practical elements of the workshop will include:
· Comparison of two texts for readability: initial impression and later in-depth comparison using readability statistics and web-based tools
· Analysis of participants’ own writing using readability statistics
· Exercises illustrating important determinants of sentence length and therefore readability: the active/passive voice, nominalisation and joining words to improve sentence flow.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

MDA1
Literature Reviews for Medical Devices
Medical Devices - Advanced

Participant Profile

This workshop is intended for medical writers who are either interested in working with medical devices or who already work with medical devices and are involved in preparing literature reviews for clinical evaluation reports (CERs). Familiarity with European medical device regulations and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.

Objectives

The aim of this workshop is to understand how to write a literature review as part of a CER. Participants will learn how to prepare a literature review to current MEDDEV 2.7/1 rev. 4 requirements.

Content

The workshop will explain the following:
· the role of the literature review in the clinical evaluation of a medical device;
· the scope of the literature review;
· developing literature search strategies for the subject device and state of the art (current knowledge);
· writing the state of the art section;
· screening and appraising the literature for the subject device;
· data extraction;
· analysing and presenting the literature in the CER;
· literature disposition;
· citing references and listing excluded references.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

MSF12

Participant Profile

Experienced regulatory writers with little or no experience of the clinical development of antibiotics.

Objectives

Provide an introduction to bacterial infections and their development so that the regulatory writer feels confident in discussing the development of documents.

Content

Starting work in a new therapeutic area is always a challenge but several factors make infection/antibiotics particularly difficult. This interactive workshop aims to demystify some of the daunting complexities that regulatory medical writers will encounter when starting out in this fascinating field. As background, the workshop will cover nomenclature and classifications, the incidence of common bacterial diseases, modes of action for common drug classes and the main mechanisms of bacterial resistance. After covering these basics, attendees will explore the practicalities of measuring resistance and then look at the key considerations for study design, conduct and reporting. Throughout, the emphasis will be on equipping the regulatory medical writer with the knowledge needed to contribute meaningfully to the development of clinical study documents.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 0:30hrs

15:00
to
15:45

Refreshment break
19:30
to
22:00

Tour options
Social

Saturday 5 May

07:00
to
07:30

Easy morning yoga session
Drop-in Session
07:45
to
08:25

English Breakfast Session 2
Short Seminar - Not for credit

Participant Profile

Drop in on this interactive short seminar for a quick ‘English’ fix looking at major and minor issues with the use of English in our context to set you up for the day. Come with questions if you want, but remember we have only 40 minutes. Or send them to me upfront: alistair.reeves@t-online.de

Content

Topics today are:
· Singular or plural verb with ‘none of’?
· Singular or plural with ‘no’ as an adjective?
· Writing the date
· ‘Set-up’ or ‘Setup’, ‘Workup or ‘workup’ – hyphenate or not?
· Your questions
08:30
to
12:30

EPDC Meeting
Committee Meeting

Participant Profile

EPDC Committee Members only.
08:45
to
11:45

PTF19
An Introduction to Marketing for Medical Writers
Professional Techniques - Foundation

Participant Profile

Anyone who wants to gain a better understanding of the basic concepts and theories of marketing.

Objectives

Participants will gain insights into how pervasive and persuasive marketing is, and how attention to detail can help them to improve both their own and their firm’s image. By demystifying marketing, workshop participants can both identify and implement simple techniques in many elements of their daily work. Participants will have to bring their own marketing examples to the workshop for discussion. This thought-provoking workshop will lead you to view the process of marketing in a new light. (Please note that the main workshop focus is on general marketing theories and real-life examples drawn from different industries).

Content

Topics covered include the marketing concept, the marketing mix, buyer behaviour, the promotional mix, and strategic analysis. The workshop includes a mixture of lecturing, real-life examples, group activities and discussion.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

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: 2:30hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
11:45

DDF4
The Patient Information Leaflet
Drug Development - Foundation

Participant Profile

This workshop is aimed at all medical writers, including native English speakers, who would like to develop their skills and awareness when writing information for patients.

Objectives

The vocabulary and style that medical writers normally use for communicating with a scientifically educated audience are not always appropriate for communicating with the public. The purpose of this workshop is to guide medical writers to view their use of language from a patient’s perspective. Clinical trial Patient Information Leaflets (informed consent documents) will be used to structure the workshop, however, the principles apply to most written communications with the public. On completion of the workshop package, participants should be able to write a patient information leaflet suitable for use in a clinical trial.

Content

The workshop will start with some information about the content of Patient Information Leaflets, including regulations and other important sources of elements of informed consent. The workshop will continue with some guidance on style and communicating with patients. Particular emphasis will be placed on identifying and avoiding jargon. Workshop exercises will be used to practice modifying typical source information into wording suitable for inclusion in a Patient Information Leaflet. There will be some discussion about obtaining informed consent in special cases, and common questions that arise.

Pre-Workshop Assignment Length: 1:00hrs

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 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.
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

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

Participant Profile

This workshop is intended for medical writers who wish to learn more about the global regulatory environment for pharmaceuticals.

Objectives

The purpose of this workshop is to introduce medical writers to the regulatory and cultural underpinnings of differing processes applied to the preparation, submission, review, and approval of regulatory submissions for pharmaceuticals to EU and US licensing authorities. On completion of the workshop, attendees should better understand the way the agencies operate and the requirements (as stated in the regulations and implicit in past practice) for preparing a successful dossier.

Content

There is an internationally agreed format for the presentation of an application dossier for a marketing authorisation for a pharmaceutical product: the Common Technical Document (CTD). It is accepted by all ICH member countries; however, this does not mean that the way in which reviewers approach the assessment is the same or that the processes for submission, review, and approval are identical. In particular, there are significant differences between the way data are summarised and the approach taken by European reviewers compared to that taken by their counterparts in the USA. While some of these differences may ultimately evolve to a state of commonality, others likely never will.
Participants will be introduced to the origins of drug regulations, and will review some of the labyrinthine procedures associated with preparing, filing, and defending a licensing application. Cultural and practice differences and similarities between the EU and the USA will be explored. This workshop does not cover the regulatory requirements for medical devices or vaccines.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

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 attendees 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

08:45
to
12:15

MSF7
Fundamentals of Immunology
Medical Science - Foundation

Participant Profile

This workshop is intended for medical writers with little or no background in immunology or those who are interested in refreshing their knowledge on the basic principles of immunology

Objectives

The purpose of this workshop is to introduce medical writers (irrespective of their area of specialisation or the nature of documents they work on) to the basic principles of immunology. The ultimate aim of the workshop is to enable medical writers to better understand the meaning of the results of clinical trials.

Content

The workshop will cover the following aspects: structure and functioning of the immune system, types of immunity and interactions, and immune system related disorders.

Based on the preworkshop assignment, two different group activities will take place:
1) The development of a glossary of specific terminology in immunology
2) Consolidated presentation of preworkshop assignment slides by participants

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

10:00
to
10:45

Refreshment break
11:45
to
13:15

Lunch
13:30
to
14:00

Content

The conference closes at 13:30 on Saturday 10 November