Overall Programme

49th EMWA Conference - Malmö

7 to 9 November 2019

See Fees and Registration for details of fees and waiting list procedures for events (including EPDP workshops).  

 

EPDP workshops

If you attend an EPDP workshop and successfully complete the pre- and post-workshop assignments you can gain an EPDP credit (2 for a double workshop), which can contribute towards an EMWA certificate of professional development. See the EPDP brochure for details. However, you are welcome to attend workshops without doing them for credit. 

Before registering for a workshop, please click on its title and read the abstract. 
Some workshops (including foundation ones) are designed for people with some knowledge or previous experience. Some may require participants to bring along a laptop or other equipment. Please contact info@emwa.org if you have any queries. 

After registering for a workshop, download the pre-workshop assignment using the link on the right hand side of the workshop listing. Please note it is your responsibility to download the pre-workshop assignment(s) for the workshop(s) you are registered for. Head Office will not be distributing any pre-workshop assignments.

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Thursday 7 November

11:00
to
11:45

MD-SIG Meeting
Not for credit

Participant Profile

MD-SIG meeting – please join us to get informed about the latest activities

Pre-Workshop Assignment Length: hrs

Post-Workshop Assignment Length: hrs

11:30
to
20:30

Registration
11:45
to
13:30

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

MDF3

Participant Profile

This foundation workshop is for those who:
· have never written a clinical investigation plan (CIP, synonym clinical study protocol) for medical devices
· are coming from pharma, or
· already have some experience in writing CIPs and want to gain a more profound understanding of this document.

No attendance at a previous workshop is required. However, participants would benefit from having previously attended 'Basics of Writing for Medical Devices under the MEDDEV rev. 4 and new Medical Devices Regulations' (MDF1).

Objectives

The objective of this workshop is to teach participants how to write a CIP for medical devices. Those who have already some experience of writing CIPs will gain a deeper understanding of the background and points to consider.

The workshop will focus on CIPs in Europe.

Please bring your mobile phone, tablet or laptop with you as you will need them for exercises during the workshop.

Content

Step-by-step, chapter-by-chapter participants will be taught how to write a CIP for medical devices. Not only will the different content requirements be explained, but also the strategic impact of specific sections. The workshop will also cover tips and tricks on how to gain specific information.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:30hrs

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 requires public disclosure of clinical trial (CT) documents. The EU General Data Protection Regulations (GDPR) requires that personal data in these documents be protected. Though divergent at first glance, these new requirements actually are aligned to benefit patients. As medical writers, we need to find the right balance between disclosure and data protection while maintaining the scientific utility of the documents we write.
The objective of this workshop is to help medical writers deal with different CT documents impacted by the EMA Policy 0070 and the GDPR. 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 confidentiality and of non-compliance.

Content

The workshop will cover:
· a short introduction to CT transparency and disclosure, the key regulations (i.e., EMA Policy 0070, GDPR), and definitions of key terms
· benefits, challenges, and risks of disclosure
· CT documents impacted, with focus on the study protocol and the clinical study report
· personal data pseudonymisation (“redaction-friendly”) techniques at the document level
· working with other functional groups to ensure patient data protection in CT documents

Hands-on exercises will be provided on
· identifying data protection risks
· pseudonymisation strategies to mitigate risks to patient confidentiality.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

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

13:30
to
17:00

LWA4
Beyond Simple Editing
Language and Writing - Advanced

Participant Profile

Experienced medical writers or editors who are ready to move into a more senior role. Participants should be competent in editing for style and formatting and in basic language editing.

Objectives

To consider the elements of in-depth editing – that is, editing that involves revising a piece of text to maximise its effectiveness.

Content

We will briefly review the elements of editing and then consider how in-depth editing can improve the quality of a document. Participants will carefully examine a piece of text using questions raised as part of the pre-workshop assignment. We will then discuss how the text could be revised, and what should be prioritised if working to a deadline. Exercises will focus on parts of the document and participants will complete the revisions as part of the post-workshop assignment. The workshop will be interactive, with time for the participants to share their experience. The workshop will not cover on-screen editing, although we may discuss using on-screen editing techniques to support editing.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

PTF40
Statistical Testing
Professional Techniques - Foundation

Participant Profile

This workshop is for participants who wish to develop or refresh their understanding of how basic statistical testing procedures work.
Participants should:
· be familiar with basic arithmetic, including squares and square roots
· bring a calculator or smartphone app capable of square and square root functions
· come prepared to engage in exercises and discussions

Objectives

Non-statisticians often see statistical testing as a black box, into which statisticians pour numbers, to make p-values for medical writers to report. The underlying mathematics can appear intimidating, so this workshop breaks down the elements of some basic statistical tests, to illustrate how they work and what factors influence the results. Participants will gain a greater appreciation of how the outputs of statistical tests are generated, and what real-world decisions influence the likelihood of a significant outcome. This understanding will support their work when reporting statistical results.

This is a highly interactive workshop which includes four group exercises.

Content

This workshop addresses the following areas:
· Why we need statistical tests
· Populations and samples
· Continuous and categorical variables
· Describing continuous data
· Normal distribution
· Hypothesis testing
· Test on continuous data (Student’s t)
· Confidence intervals
· Test on categorical data (chi-square)
· Statistical significance and clinical relevance
· Type II errors (sample sizes)
· Data errors, recall bias, multiple testing

Participants should note that the concepts of mean, standard deviation, and the normal distribution are also covered in workshop PTF30a. This workshop differs from PTF30a in that it focuses in detail on the conduct of statistical tests, and includes an explanation of mean, standard deviation, and normal distribution as it is essential to have these fresh in the mind in order to understand how statistical testing works.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

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
· Determine which sections of a CSR (ICH E3) are relevant for a manuscript
· Establish guidelines for writing a manuscript based on a CSR
· Determine how to use the tables and figures from a CSR
· Analyse examples of CSR text, figures and tables 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

PTA14
Building Medical Writing Teams
Professional Techniques - Advanced

Participant Profile

Managers of writing teams (in-house or freelance), experienced writers looking for a career path into management, freelancers working working in networks or in a team, and those who are interested in building network-teams. The workshop mainly focuses and draws examples from regulatory writing teams.


Complementary workshops: PTF8–Cross-cultural communication, PTA11–Strategies for Improving Document Quality, PTA12–Interpersonal Skills for Medical Writers, PTA13–The Art of Mentoring.

Objectives

Participants should have a greater understanding of the unique and varied composition of medical writing teams and the strategies and skills that can be used to build, manage and expand dynamic teams of writers in any writing environment.

Content

We will discuss how team leaders and managers can use a variety of strategies and skills to build, manage and expand teams of writers, and how they can harness each members’ skills, knowledge and expertise to ensure production of high quality work within budgeted hours and timelines. We will also cover establishing a team atmosphere to provide an encouraging environment for learning, developing and sharing writing skills at the level, need and desire of each team member.

The workshop will cover:

· What a real team looks like
· How a real team functions and develops
· How experienced writers benefit from the team model
· Freelancers as part of the team
· Global teams – team cohesion, distance communication
· Expanding the team
· Retention strategy and succession planning

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:30hrs

Content

Welcome from the EMWA President and Conference Director, a cultural talk and a lecture on reclassification of type 2 diabetes - steps towards precision medicine.

A novel reclassification of type 2 diabetes - steps towards precision medicine - Leif Groop

Myths and truths about Sweden and Swedes - Karin Gewart

A welcome to Malmö - Stephen Gilliver

Regional Talk - Sten Theander
19:00
to
20:45

Networking Reception
Social

Friday 8 November

07:00
to
07:30

Easy Morning Yoga Session
Drop-in Session
07:45
to
08:15

EMWA/AMWA/ISMPP Joint Position Statement on Predatory publishing
08:45
to
11:45

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

Participant Profile

This workshop is intended for writers who have basic experience in regulatory medical writing (RMW) and an interest in document consistency and project management. Writers without previous RMW experience could also benefit from this workshop after completing one additional pre‑workshop requirement.

Objectives

This workshop aims to demonstrate what consistency is, how writers can recognize and avoid inconsistencies, and provide tips for project management in large-team submission projects. Following this workshop, participants should be able to recognize the different types of consistency, identify inconsistencies and avoid/correct them, and manage demanding submission projects (including timelines) with more confidence and competence.

Content

The workshop will give good and bad examples of document consistency and demonstrate how writers can recognize and avoid/correct inconsistencies; present advice for improving inter‑ and intra‑document consistency; use examples from submission projects to explain strategies for consistent complex documents; provide project management tips to help face the challenges of working in large teams of writers and reviewers; provide tips for better team communication and timelines management.

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

PTF41
Basics of Medical Statistics for Medical Writers Part 2
Professional Techniques - Foundation

Participant Profile

This workshop is aimed at medical writers who would like to improve their understanding of statistics. Prior attendance at “Basics of medical statistics for medical writers part 1” is not required; however, it is assumed that participants are already familiar with basic statistical concepts such as P values and estimation. Anyone who is not confident in their understanding of such concepts is encouraged to attend “Basics of medical statistics for medical writers part 1” before taking this workshop.

Objectives

To help medical writers to understand the some of the statistical techniques used in clinical research (both in clinical trials and epidemiological research).

Content

· Brief review of the basics: P values, confidence intervals etc
· Regression analysis
· Intent to treat and per protocol analyses
· Missing data
· Interim analyses
· Primary and secondary analyses

The workshop will focus on what medical writers need to know about statistics to be able to present them in reports and publications, and not on mathematical details.

Please note that there is some overlap between this workshop and workshop PTF40, "Statistical testing". However, anyone interested in learning more about statistics should not be afraid of attending both workshops, as the material will be presented in different ways, which can often be a helpful way of consolidating learning.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:30hrs

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

08:45
to
12:15

MDF2a
Going from Pharma to Medical Devices
Medical Devices - Foundation

Participant Profile

This workshop is primarily intended for medical writers who have some knowledge of regulatory guidance and are interested in working with medical devices. 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 the EU regulatory pathways, to become familiar with the documents used for medical devices to see these in the light of those used for pharma, and to identify transferable medical writing skills between pharma and medical devices.

Content

The workshop will compare and contrast Pharma vs Medical Devices with respect to
· definition of terms
· product development steps
· EU regulatory pathways, guidelines and requirements
· documents
· medical writing transferrable skills

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

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

08:45
to
12:15

DDF18
Good SOP Practice: Processes and Authoring
Drug Development - Foundation

Participant Profile

Medical writers working in clinical research organisations or the pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers following, reviewing and revising existing Standard Operating Procedures (SOPs), or creating new SOPs. This is an ideal forum for writers whose organisations or clients have scope to improve their SOPs.

Objectives

• To view SOPs from several perspectives and use this valuable multi-dimensional view in SOP development
• To link process to writing and reviewing from the outset
• To discuss good (and poor) SOP practices in detail
• To put theory into practice using in-workshop exercises
• To place SOPs in the current context by considering their place and management in the electronic environment
• To understand how to create and maintain good SOPs or review existing SOPs

Content

• What is an SOP?
• Why do we need SOPs?
• Using, reviewing and creating SOPs: A multi-dimensional perspective
• SOP components
• Planning the SOP
• Language and authoring tips
• SOPs in an electronic age

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

09:00
to
17:00

Executive Committee Meeting
Committee Meeting
12:15
to
13:30

Lunch

Content

· Accelerated Publications
· Open Access services and discount schemes
· Thematic issues and editorial calendars
· Manuscript preparation
o Integrating multimedia resources in articles
o Plain Language Summaries
· Post-publication article promotion

Participant Profile

This Foundation workshop is intended for participants who wish to learn about the requirements, timings, and processes used for disclosure of clinical trial results in public databases in the USA (via ClinicalTrials.gov) and in the EU (via EudraCT). Previous experience in clinical trial registration and results disclosure is not required, but a working knowledge of and navigation through clinical study protocols and clinical study reports is advantageous.

Objectives

Upon completion of this workshop participants will:
· understand the requirements for disclosure of clinical trial results in the US and EU,
· be familiar with the content of both US and EU clinical trial results records,
· understand the similarities and differences between the two databases, and
· appreciate the importance of content consistency across clinical trial documents that reach the public domain.

Content

The workshop will contain the following:
i) introduce the legal regulations and non-legal requirements governing clinical trial disclosure
registration (of new clinical trials) and summary results (for completed clinical trials) relevant for the US and EU regulatory authorities,
ii) summarize the requirements and content of both the US and EU clinical trial summary results records, including practical tips on how to approach authoring of the results entries in each database,
iii) live presentation of the database structure and study results entry into the databases (ClinicalTrials.gov and EudraCT),
iv) illustrate, with practical examples, the need for content consistency with respect to Clinical Study Protocols, Clinical Study Reports, Plain Language (layperson) Summaries, and journal publications (including the requirements of the ICMJE for publication of results from interventional clinical trials in clinical/biomedical journals).

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
16:30

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

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

PTF8
Cross-Cultural Communication
Professional Techniques - Foundation

Participant Profile

Anyone who wishes to explore how to recognise a cultural issue or problem (particularly in a medical writing setting) and how to approach it wisely. Curiosity and willingness to share own experiences are the most important prerequisites.

Objectives

By raising awareness about cultural differences and key factors involved in intercultural communication, this workshop aims at giving participants an increased ability to recognise cultural issues in situations that medical writers frequently encounter, and the basic skills needed to avoid potential problems.

Content

The ability to operate effectively in multicultural contexts has become a key business skill. Medical writers often work in international teams and many of us have experienced different working styles and ways of communicating that can create a host of problems. Knowledge about cultural characteristics and differences, and how they affect medical writing can diminish these problems. The workshop will be a mixture of lecturing, discussions and group work. The most common ways of distinguishing cultures from each other (national and organisational) will be covered and the pre-workshop assignment (the Enneagram’s nine personality types) will help to raise awareness about one’s own personal inclination to meet an unknown culture. Discussion groups will be put together from information given in the pre-workshop assignment.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

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

DDF17a
Ethical Issues in Clinical Trials
Drug Development - Foundation

Participant Profile

This workshop is intended for medical writers (and others) who are interested in clinical trials and would like to know more about the evolution of ethical principles associated with human subject participation. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical trial ethics will be provided for interactive discussion.

Objectives

To give an overview of the various ethical considerations associated with conducting clinical trials, including institutional oversight, pre-approval access, regulatory authority clearance, subject informed consent, investigatory conflict of interest, issues of fraud, and ensuring subject safety and well-being.

Content

This workshop will consist of a combination of presentations on relevant ethical issues, with respect to clinical trials, and group discussions on challenging ethical considerations of some “real-world” case studies. The presentations will focus on the importance of ethics in GCP, the informed consent process, and the challenges that may arise in developing countries. Practical experience will be shared with the participants.

Pre-Workshop Assignment Length: 3:00hrs

Post-Workshop Assignment Length: 2:00hrs

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

13:30
to
17:00

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 fundamental immunological concepts which in turn helps to better interpret 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 to co-create a glossary of specific terminology/concepts in immunology.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

17:15
to
18:45

Lifestyle choices for health and sustainability
Short Seminar - Not for credit

Participant Profile

To provide the latest scientific information to medical writers so they can make better decisions for themselves and their environment.

Objectives

There is a growing body of evidence showing that our lifestyle is the main reason why most of us get sick and die. The evidence also shows that changing our lifestyle can not only prevent but also help treat many diseases. This is important to everyone but especially for medical writers since our jobs are sedentary and stressful. However, there are things we can do to improve our health and productivity, starting with what we all do many times a day: eat and drink. At the same time, our diet is not just harming us but also planet Earth. How does that exactly happen, and how can diet possibly help with that? Every time we eat or drink is an opportunity to take steps that can improve our health and help us reach our maximum performance in all aspects of our lives. If it even helps fight climate change, the greatest challenge of our time, why not find out more about it?

Content

How our lifestyle, particularly what we eat, affects us
How changing our habits improves healthcare outcomes
Our diet and climate change
Practical tips for medical writers
17:15
to
19:00

Freelance Business Forum
Discussion Forum
19:15
to
23:15

Social events
Social

Saturday 9 November

07:00
to
07:30

Easy Morning Yoga Session
Drop-in Session
08:30
to
12:30

EPDC Meeting
Committee Meeting

Participant Profile

EPDC Committee Members only.
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
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
12:15

MCF17a
Using Writing Guidelines
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: 2:00hrs

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

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

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
12:15

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

Participant Profile

Participants should be familiar with the drug development process and have an understanding of basic pharmacokinetics.

Objectives

After completing the workshop, participants will have an understanding of the strategic role PK/PD modelling plays in drug development. In addition, they will gain an appreciation of how modelling can influence the claims that can be made on the drug label. They will be better placed to discuss modelling issues within projects, and to incorporate modelling outcomes into reports and regulatory documents.

Content

The rationale for modelling in drug development is presented, along with the regulatory view. Different modelling techniques (compartmental, population, pharmacokinetic/pharmacodynamic [PK/PD], physiologically based (PBPK) are discussed in terms of their principles, their role within a drug development programme, and common terms used in their execution. This is illustrated with examples from the literature and the presenter’s personal experience.  How modelling output can influence the claims made on the drug label will be discussed. The workshop consists of modules interspersed with individual and group learning tasks.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

11:45
to
13:15

Lunch
13:15
to
13:15

Content

The conference closes at 13:30 on Saturday 11 November