52nd EMWA Conference - NovVirtual

November 2021

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

Workshop full? You can ask to be put on a waiting list: see Fees and Registration for more information. 

 

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 allow you to apply for an EMWA certificate of professional development. See the EPDP brochure for details. However, you are welcome to attend workshops without doing them for credit. 

When you have registered for a workshop, download the pre-workshop assignment using the link on the right hand side of the workshop listing. You do not need to wait for further instructions from the workshop leader.

Times below are CET. 

 

 

 

 

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Saturday 6 November

Participant Profile

This workshop is intended for medical writers with basic or very little knowledge in regulatory writing under either the Medical Devices Directive 93/42/EEC (MDD) or under the Medical Devices Regulation 2017/745 (MDR).

Objectives

The Medical Devices Regulation 2017/745 (EU MDR) sets out new requirements for IFUs. For legacy devices, part of the content of the IFUs may come from the Clinical Evaluation of the device, while for new devices it may come from clinical investigation plans conducted before marketing authorization. Medical writers are essential to support manufacturers in writing clear and useful IFUs. These documents are subject to predefined review cycles and depend on several other input documents. This workshop will give you profound insights into the regulatory requirements for IFUs, best practice recommendations on how to draft IFUs, and insights into common pitfalls and tips on how to avoid them.

Content

The course includes the following topics:- Regulatory framework: EU MDR 2017/745 requirements and definitions- Content and structure of the Instructions for Use- Where do all those contents come from? Legacy devices vs new devices- Recommendations for the writing process: Tips to improve writing of the IFUs- Usability and readability- Images, photos and symbols- Where else and how the content of IFUs is used.We will navigate through many examples about content, writing and possible pitfalls. You will get insights on how to improve the quality of IFUs and contribute to the drafting process.

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

Monday 8 November

09:15
to
12:45

MCA28
Publication Planning
Medical Communication - Advanced

Participant Profile

This workshop is aimed at experienced writers who are interested in or work in publication planning. It is particularly useful for writers who are expected to recommend journals for publications, and congresses for presentations, or are involved in development of scientific communication plans. Participants should know the basics of effective and ethical scientific communication.

Objectives

The workshop objective is to convey concepts of strategic communication and publication planning in a unified approach on which to base development and tracking of a publication plan.

Content

Publication plans incorporate details of clinical trials programmes and make recommendations on publications – e.g. publication types, journals, meetings and timing to maximise publication opportunity.
The introductory part will refresh the concept of effective communication and the environment of publications. The workshop will cover issues to consider during development of a data-driven plan; e.g. the influence of data availability, journal and meeting choice, and milestone dates. The most relevant aspects of an effective communication strategy and its implementation will be actively discussed.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

Participant Profile

This workshop is intended for people who are new to medical writing and who are involved in writing the safety sections of clinical study reports or related safety summaries.

Objectives

This workshop is designed to give medical writers insight into the processes by which adverse event and concomitant medication data are generated and recorded during clinical trials and the subsequent handling of the data. On completion of the workshop package, participants should be confident in their approach to writing the adverse event and concomitant medication sections of documents relating to clinical trials.

Content

The role of the medical writer in preparing summaries of safety data is to take a large amount of information and to present the most important points in a useful and understandable format. The challenge for the writer is to identify what is important and to answer the readers’ questions before they have been asked. The collection of clinical safety data on a drug begins at the clinical trial level. All safety summaries are built upon this starting point. The aim of the workshop is to bring the data to life so that the writer can present safety data that is interesting to the reader.

It is not necessary for participants to attend both Part 1 and Part 2 of the workshop but the two parts provide a complete picture of the safety data that is usually collected in clinical trials and presented in study reports.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

Tuesday 9 November

09:15
to
12:45

MCF18
Abstracts
Medical Communication - Foundation

Participant Profile

This workshop is primarily intended for medical writers who write publications, posters, or conference presentations and who want to improve their abstract writing skills. Medical writers who write summaries that must fit strict format and word limits can also benefit from this workshop. Participants should have some experience writing manuscripts, posters, or conference presentations.

Objectives

A well-written abstract allows a reader to quickly understand what an article, poster, or presentation is about, and in many cases, they are the only thing they see. They are also used by journal editors to determine whether to select a manuscript for publication and by conference committees to determine whether a study warrants an oral presentation. Therefore, the abstract needs to capture the reader’s interest and transmit the key messages and information, all within strict limitations of length and format. This can pose a significant challenge, even to experienced writers.The objective of this workshop is to learn to identify and condense the key information from a study into the limited number of words and appropriate format for an abstract.

Content

Participants will learn about the purposes of abstracts; key considerations in abstract writing; the different kinds of abstracts and what they should and should not contain; problems in abstracts and how to avoid them; tricks for shortening text; and guidelines for abstracts.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:00hrs

13:30
to
17:00

DDA32
Writing Development Safety Update Reports
Drug Development - Advanced

Participant Profile

This workshop is for medical writers who would like to obtain knowledge about the Development Safety Update Report (DSUR). Participants should have some experience of collection and analysis of safety data, and an understanding of safety monitoring during clinical trials. Participants without this knowledge or without experience in safety/pharmacovigilance writing should in advance attend the course DDF32.

Objectives

This workshop will provide participants with a comprehensive overview and the knowledge needed to write a DSUR. Starting with the DSUR’s regulatory background, purpose, and goal, the workshop will guide participants through the DSUR requirements, document content, the preparation and writing process.

Content

Since 2011, DSURs are required in the ICH region for all marketed drugs or drugs under development for which clinical trials are ongoing. The aim of this workshop is to explain what the DSUR is, when it needs to be written (and when possibly not), which data and information need to be included and how to present them. It also provides guidance on the writing and project management process, taking into account that the DSUR is a document that requires an interdisciplinary and well-organised team effort within challenging timelines. Concise as per guidance, with a clear and logical structure, the DSUR nevertheless has some pitfalls in store that are also discussed in this workshop. To bring life and colour to the theory, all of this is illustrated with examples from the daily practice of preparing, writing, and submitting DSURs.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

Wednesday 10 November

09:15
to
12:15

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

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: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

Thursday 11 November

09:15
to
12:45

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 papers for others, and for those who wish to improve their own papers.

Objectives

To increase the likelihood of producing focused – on a clear purpose statement – coherent research papers with well-structured in-depth argumentation.

Content

Participants will learn to create a storyline, to clarify how a study fits into and strengthens the body of knowledge within a field, to distinguish clearly between the introduction and discussion sections, and to develop logical method-centered arguments in the discussion. We will discuss aspects of an example paper – long-term follow-up of breast cancer treatment – and suggested revisions of it, in groups and in plenum. Participants will receive the paper and suggestions before the workshop (as part of the preworkshop assignment). Other topics are the Cs of communication, a 6-step publication-planning-and writing process.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
16:30

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

Friday 12 November

09:15
to
12:45

DDF38a

Participant Profile

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

Objectives

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

Content

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

Pre-Workshop Assignment Length: 3:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
16:30

PTF4

Participant Profile

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

Objectives

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

Content

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

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

Saturday 13 November

09:15
to
12:15

DDF37

Participant Profile

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

Objectives

The EU Clinical Trial Regulation (CTR) and the EMA Policy 0070 require 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 sets of requirements are actually 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 requirements for transparency and public disclosure 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 compliance.

Content

The workshop will cover:
· a short introduction to CT transparency and disclosure, the key regulations (i.e., EU CTR, EMA Policy 0070, GDPR), and definitions of key terms
· benefits, challenges, and risks of public 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
· real life examples
· hands on exercises

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

16:00
to
19:30

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 syntactic writing distractions.

Content

Do you want to enhance your copyediting skills with a systematic approach? If so, the following steps in the analysis of 24 sets of sentences have been shown to be effective. First as a pre-workshop assignment, select the clearer sentence in each set; that is, the one free of a syntactic distraction which you will describe by your own distraction nomenclature (e.g.,wordiness). Second from a compilation of the preworkshop assignments from all workshop enrollees prepare to present the selection and nomenclature for two assigned sets. Third, as a member of a clarity-testing panel, listen to the comments of other members and the workshop leader who will provide systematic nomenclature. Fourth, as a post-workshop assignment, send a list of sentences indicating any change of selection and/or nomenclature. Fifth, receive feedback from the workshop leader about your selections and nomenclature.

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

Monday 15 November

09:15
to
12:45

DDA27
Medical Writing for Biosimilars
Drug Development - Advanced

Participant Profile

Participants should be familiar with the drug development process and have an understanding of basic pharmacokinetics and statistics. In addition, participants should have experience with clinical study reports and regulatory submission dossiers.

Objectives

After completing the workshop, participants will have an understanding of the differences between biosimilars and NBE development. In addition, they will understand how these differences influence the development of clinical documents. They will appreciate the challenges they might face when working in this relatively new field of Medical Writing.

Content

• General overview on biosimilars clinical development
• Dealing with biosimilars clinical study reports (Phase I and Phase III)
• Dealing with the clinical documents of a biosimilars submission dossier

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
16:30

MSF10a
An Introduction to Vaccines
Medical Science - Foundation

Participant Profile

This workshop is intended for anyone interested in learning about vaccines, particularly scientific/medical writers with little or no background on the topic, but also those interested in refreshing or updating their knowledge. Participants should have a basic understanding of molecular biology (DNA RNA protein).

Objectives

To enable writers to understand and appreciate the basic principles of vaccinology, and how these principles are applied in vaccine development.

Content

The workshop will cover the following topics:
· Basics of immunology
· History of vaccines
· Types of vaccines and their production, administration, mode of action, and known/potential issues
· Recent developments such as COVID19 vaccination, mRNA vaccines, and vaccines against cancer

Pre-Workshop Assignment Length: 0:20hrs

Post-Workshop Assignment Length: 2:00hrs

Tuesday 16 November

09:15
to
12:45

PTF42
Essentials of Data Visualisation
Professional Techniques - Foundation

Participant Profile

Medical writers with 0-4 years of experience. No prior knowledge in visual communication is required.

Objectives

To learn basic guidelines to achieve appropriate graphical representations of data which retain the main message and improve visual appeal. At the end of the course, participants should be able to: Understand the principles of data visualization; Identify a main message for each graphical representation; Select an appropriate graphical representation for each type of data; Improve clarity of the chart or table.

Content

Medical writers need to present data clearly and accurately. Visual representations of data allow to communicate information faster and easier to all audiences. Tables and charts are the most direct data visualization tools. However, if done inappropriately they can mislead the audience and convey the wrong information. During the first part, we will introduce participants to the basic principles of design and fundamentals of visualization. Next, we will discuss applications and requirements of the most used graphical representations in medical writing – charts and tables. We will cover the choice of a “main message” for each image, and formatting issues that may mislead the reader. Examples and practical group activities are included. Finally, we will provide specific tips to achieve clear visuals focused on the data. Although some topics of the workshop may partially overlap those presented in PTF1, this course is more oriented towards fundamentals of design and visualization.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

MCA3a
Systematic Reviews
Medical Communication - Advanced

Participant Profile

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

Objectives

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

Content

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

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

Wednesday 17 November

09:15
to
12:45

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

Participant Profile

Note this is a double workshop – Part 1 is on Friday morning 14 November and Part 2 is on Friday afternoon 14 November. You must register for both parts.

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 authors
· 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

13:30
to
17:00

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? • Estimating treatment effects • Hypotheses and statistical tests • Using statistical analysis plans • Understanding statistical output for efficacy • Efficacy in clinical study reports

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

Thursday 18 November

09:15
to
12:45

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

Participant Profile

Note this is a double workshop – Part 1 is on Friday morning 14 November and Part 2 is on Friday afternoon 14 November. You must register for both parts.

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 authors
· 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

13:30
to
16:30

PTF24
Information Sources for Medical Writers
Professional Techniques - Foundation

Participant Profile

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

Objectives

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

Content

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

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

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

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

Friday 19 November

Participant Profile

This workshop is aimed at medical writers, both new and experienced, who would like to improve their understanding of One Health. This is a foundation level workshop. No previous knowledge of One Health is assumed, but experience would be helpful for group work and discussion.

Objectives

The workshop is expected to be of benefit to medical writers coming in touch with One Health topics such as antimicrobial resistance, zoonoses, comparative or translational medicine, and food safety.

Content

One Health is a transdisciplinary approach to human, animal and environmental health.In 1858 Rudulf Virchow noted that “Between animal and human medicine, there are no dividing lines – nor should there be. The object is different, but the experience obtained constitutes the basis of all medicine”. Today, 60% of existing human infectious diseases are zoonotic, and 75% of emerging diseases of humans (including Ebola, HIV, Influenza) have an animal origin.
Workshop participants will be introduced to the definition and history of One Health. Particular emphasis will be on Zoonoses, Public Health, Comparative and Translational Medicine and Microbiology. Examples of zoonoses, emerging infectious diseases of animal origin and also antimicrobial resistance will be used to illustrate how human health can be impacted and participants will have the opportunity to discuss these along with the emerging opportunities for medical writers/ communicators. Participants will gain a broad understanding of One Health topics linking human and animal health, which they can use when working in this area.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
16:30

PTF3
Using Statistics in Medical Writing
Professional Techniques - Foundation

Participant Profile

Medical writers and editors with any level of experience who wish to learn more about the statistics they work with.

Objectives

At the end of the course participants should understand the following:
·           Populations to be analyzed: intent-to-treat, per-protocol, safety-evaluable, worst-case.
·           Missing Data and Sensitivity Analyses
·           Descriptive statistics: mean, median, mode, range, percentiles, box plot, normal and non-normal distributions, parametric and nonparametric tests, coefficient of variation
·           Odds and Hazard Ratios
·           Estimates and confidence intervals, and p-values
·           Sample size calculations and what they mean

Content

We all write about statistics, but how many of us really have an intuitive feel for what we're writing about? This workshop is designed for participants who have little or no background in statistics. The following statistical concepts will be covered in depth: types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and sample size calculations. Emphasis will be placed on understanding statistical presentations and reporting statistical information, not on calculations or mathematical explanations.

Pre-Workshop Assignment Length: 4:00hrs

Post-Workshop Assignment Length: 1:00hrs

Saturday 20 November

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 industry best practices) 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. In addition, the Sponsor-Regulator interfaces and processes are quite different. 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: hrs

Post-Workshop Assignment Length: hrs

Monday 22 November

09:15
to
12:45

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

MDF2
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 skills between pharma and medical devices.

Content

The workshop will explain the following:
· Definition of Terms: Pharma vs Medical Devices;
· The EU Regulatory Pathway: Pharma vs Medical Devices;
· Product development steps;
· Regulations and guidelines;
· The Documents: Pharma vs Medical Devices;
· Transferable Skills;
· Case Studies.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

Tuesday 23 November

09:15
to
12:15

MDF6
Safety Reporting for Medical Devices Part 1
Medical Devices - Foundation

Participant Profile

This workshop is for everybody who wishes to embark on safety reporting/ writing for medical devices as well as those that want to learn more about the specifics of safety reporting to gain a better understanding about processes, regulations and definitions (e.g. about the differences between adverse events and device deficiencies). No previous experience is required.

Objectives

Safety reporting for medical devices is an emerging field that can utilize the skills of medical writers and several companies have started to hire medical writers for that purpose. In addition, the knowledge gained in this workshop will deepen the insights of adverse events that may also be beneficial in writing documents such as clinical investigation plans.

Content

Part 1 (of 2) provides a general introduction to safety writing including key areas medical writers may be involved in, definitions, relevant regulations and guidelines, IMDRF coding, and safety reporting including the Clinical Investigation Summary Report Form, and individual and summary reports.
The second part will touch base on topics such as literature review for trending, patient narratives, safety plan and coding, clinical events committee and data safety monitoring board guidelines, risk management documents, post-market surveillance plans, PSURs, SSCPs, and the safety part of informed consent forms, clinical investigation plans and instructions for use,

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

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

Wednesday 24 November

09:15
to
12:45

DDA14c
Periodic Benefit-Risk Evaluation Reports
Drug Development - Advanced

Participant Profile

This workshop is aimed at medical writers with some experience of assessing drug safety information, and a basic understanding of the overall drug regulatory environment. It will also be useful to writers who are familiar with other pharmacovigilance documents such as the Development Safety Update Report but have little or no experience of the requirements for PBRERs in line with GVP Module VII and the revised ICH E2C. For writers with no previous experience of pharmacovigilance documents it is recommended that they attend the foundation workshop “Introduction to Pharmacovigilance Writing” before attending this workshop.

Objectives

Periodic reports are required by the regulatory authorities to provide updated information on the world-wide safety experience with marketed drugs. Medical writers are increasingly being asked to compile such reports on behalf of pharmacovigilance departments. In July 2012, new pharmacovigilance legislation came into effect across the EU updating the required format and content of a periodic safety update report (PSUR). The document now includes efficacy data as well as safety data and has been retitled the ‘Periodic Benefit-Risk Evaluation Report’ (PBRER). The aim of this workshop is to provide a clear explanation of the requirements of the PBRER in terms of what data need to be included in the document and how they should be presented.

Content

The workshop will briefly discuss the pharmacovigilance requirements for marketed drugs and the place of the PBRER in the drug safety process.

It will discuss in detail the content and method of presentation of the different sections of a PBRER in line with GVP Module VII and the revised version of ICH E2C. There will be particular emphasis on the requirements for reporting of benefit-risk evaluation and how the PBRER relates to the DSUR and Risk Management Plan (RMP).


Detailed discussion of submission schedules and the submission process will not be covered in this workshop.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs