54th EMWA Conference - Riga
3-5 November 2022
Note that after the conference in Riga, a short programme of VIRTUAL workshops will run between 7 and 18 November. The details of these virtual workshops are included in the list below.
Please note this programme is subject to change. All timings are in the venue's local time (EET). To double-check your time zone, you can use this handy tool.
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 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.
If you are intending to do the workshop for credit, please note that to gain a credit you must:
- Attend the workshop. Participants who miss more than 30 minutes of instructional time (by arriving late, leaving early or by being absent from the session for a long period) will not be eligible for credit, and
- Satisfactorily complete the pre-workshop assignment (if applicable), and
- Satisfactorily complete the post-workshop assignment, and submit it by the deadline given.
For more information about gaining credits, see the Training page on the EMWA website and the link there to the EPDP brochure.
We suggest you consider the workload associated with the workshops you are considering booking. Past conference delegates have told us that attending 4 workshops can result in a post-conference workload that is hard to fit in with work and other commitments.
Post-workshop assignments typically take up to 3 hours to complete (see the workshop abstracts for more detail) and the deadline is usually 6 weeks after the conference. Post-workshop assignments must be your own work. We do not accept joint submissions or submissions based on joint working unless specified by the workshop leader.
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. If a pre-workshop assignment is not showing after 30 September please contact info@emwa.org for further information.
IMPORTANT: if you are aiming to gain an EPDP credit for a workshop, READ THE INFORMATION in the email we will send confirming your registration. This will include the rules on how to gain credits, which can allow you to apply for an EMWA certificate of professional development. It is your responsibility to read this information and adhere to any deadlines for submitting workshop assignments.
Thursday 3 November
to
16:30
MSF3
Medical Science - Foundation
Participant Profile
Medical writers with basic knowledge of descriptive statistics who want to gain insight into the usefulness of epidemiological principles for medical writing.Objectives
This workshop is designed for medical writers with little to no experience with epidemiology and its applications in the pharmaceutical business and public health. Participants will be provided with a general overview of relevant applications of epidemiology for medical writers. The scope and relevance of contemporary epidemiology for medical writers will be discussed using examples from clinical medicine, public health and pharmacoepidemiology. In addition, commonly used measures of disease occurrence – incidence and prevalence - and their use in research designs will be reviewed. The class format combines lectures with group exercises.The main objectives are:
• Provide an overview of the applications of epidemiology in the business of medical writing
• Explain the use, significance and pitfalls of commonly used disease frequency indicators: prevalence and incidence
Content
Three major topics will be covered:• Scope of contemporary epidemiology for medical writers
• Relevance of contemporary epidemiology for medical writers
• Basic measures of epidemiology for medical writers: prevalence and incidence
Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 1:00hrs
to
16:30
MSF6
Medical Science - Foundation
Participant Profile
Participants should, ideally, have already completed Introduction to Pharmacokinetics (DDF7) and Pharmacology for Medical Writers: Part 1 – The Basics (MSF1), or have equivalent experience or knowledge.Objectives
This workshop is designed to explain the reasons behind the commonest types of adverse effects of drugs and medicines. This is intended to enable participants to understand and often predict adverse effects of new drugs and medicines. This will make it easier for participants to write accurately and effectively about the adverse effects of the drugs and medicines they will meet in their work.Content
All effective drugs (and hence the medicines that contain them) have adverse effects. To be useful, therefore, the effective (i.e. therapeutic) dose of a drug or medicine must produce only acceptable adverse effects. Adverse effects can arise in several ways, and this workshop seeks to describe these in a systematic way. The mechanisms can be broadly summarised as follows:(1) Extended normal pharmacology
(2) Parallel pharmacology
(3) Idiosyncratic reaction
(4) Pharmaceutical
(5) Pharmacokinetic interaction
(6) Pharmacological interaction
(7) Chemical interaction
Each of these mechanisms will be described with suitable examples, and the clinical significance of the different types of interaction will be discussed. Because of its largely factual content, the workshop will be mainly didactic. However, attendees will be expected to participate by answering questions as the presenter develops the explanations.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
PTA8
Professional Techniques - Advanced
Participant Profile
Medical writers who wish to understand the analyses of binary data (i.e. yes/no outcomes such as death, response to treatment etc.). Participants should be familiar with basic statistical concepts such as P-values and confidence intervals.Objectives
To gain familiarity with some of the techniques used for analysing binary data and the various measures of association, such as odds ratios or relative risks, used in analysing binary data.Content
The workshop will focus on understanding what the various statistical tests are, why they are done, and how to interpret the results. This will not be a tutorial in how to do the statistical tests (other than some of the simplest ones), as it is assumed that participants will generally receive the results of analyses from statisticians and be given the job of interpreting those results.• Definitions of binary data
• Simple statistical tests to compare binary data in 2 treatment groups: chi-squared test and Fisher’s exact test
• Measures of association of binary variables: odds ratios, risk differences, relative risks
• The Mantel-Haenszel test and other more sophisticated analyses
• Logistic regression: the most powerful technique for analysing binary data
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 3:00hrs
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
to
17:00
DDF50
Drug Development - Foundation
Participant Profile
This introductory workshop is designed for participants with little or no experience of the drug development process or the regulatory documents required.Objectives
The objective of this workshop is to give new medical writers an overview of the drug development process and the key clinical and regulatory documents commonly required in the EU. The workshop will provide a high level guide to these documents, including their purpose, target audience, the applicable regulatory guidelines, and additional resources (templates, style guides, etc.) that can help new writers prepare these documents.At the end of this workshop participants will be able to better appreciate the range of regulatory documents and understand how they fit into the different phases of drug development.
Content
The following documents will be described in the order they are needed in drug development:1. Clinical Trials
• Investigator’s brochure (IB)
• Investigational medicinal product dossier (IMPD)
• Clinical study protocol (CSP) and synopsis
• Patient information and informed consent forms (ICF)
• Clinical study report (CSR)
• Lay summary of clinical trial results
2. Clinical Development and Regulatory Strategy
• Paediatric investigation plan (PIP)
• Orphan drug application (ODA)
3. Marketing Authorisation Application
• Common technical document (CTD) clinical modules
• Summary of product characteristics (SmPC)
• Package leaflet
4. Post Approval documents
• Redaction package
For each document, the following will be summarised:
• Who will use it and how it will be used
• Who is involved in its preparation and what is the role of the medical writer
• Where the information in each document comes from
• How it fits with the other documents during drug development
• What are the applicable regulatory guidelines, template(s) and styles used
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 3:00hrs
Friday 4 November
to
11:45
PTF29
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 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 the 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 the development and tracking of a publication plan.Content
Publication plans incorporate details of clinical trial programs and make recommendations on publications – e.g. publication types, journals, meetings, and timing to maximize 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 the 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
to
12:15
LWF13+14
Language and Writing - Foundation
Participant Profile
Note this is a double workshop. 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.
· Understand how style guides, checklists and other tools can help with editing and proofreading.
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
to
16:30
MDF6
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
to
17:00
PTA6
Professional Techniques - Advanced
Participant Profile
Medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers often working to tight protocol and study report writing timelines because of inadequate scheduling of the processes leading up to and driving preparation of these documents. This is an ideal forum for writers whose organisations or clients have scope to improve their analysis and reporting processes and procedures.Objectives
Protocol writing heralds the start of the trial documentation and reporting process; the study report is often the final document prepared by medical writers. Exacting and sometimes unrealistic timelines for deliverable preparation are often agreed without consultation with the medical writer. The workshop discusses the stages before and during preparation of these documents to show how achievable timelines may be scheduled, thereby facilitating good proposal writing. After completing the workshop, participants will understand the stages involved so they can make a valuable contribution to their organisation’s or client’s process improvement activities and are better equipped to manage client expectations with regard to efficient, effective and realistic proposal writing and project scheduling.Content
• Bidding and project award process• First steps on contract win and allocation of study
• Contract review and confirmation of scope
• Communication with client and functional groups
• Scheduling
• Study protocol: stages of preparation
• Clinical study report: stages of preparation
• Proposal writing
• Business advantages of effective scheduling, influencing the process, and managing expectations
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
LWF13+14
Language and Writing - Foundation
Participant Profile
Note this is a double workshop. 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.
· Understand how style guides, checklists and other tools can help with editing and proofreading.
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
Saturday 5 November
to
11:45
PTF18a
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 is on understanding how online content differs to more traditional media. We will NOT cover technical aspects such as 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. How readers use the internet and the visual and structural aspects of presenting information online are also covered. 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 touched upon. The workshop includes practical exercises on creating internet text.Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:15
MDF8
Medical Devices - Foundation
Participant Profile
This workshop is intended for medical writers with little or no experience in regulatory writing under the Medical Devices Regulation 2017/745 (EU MDR) who would like to learn how to prepare a compliant Clinical Evaluation Plan. There is no prerequisite to attend this workshop, but basic knowledge of clinical research methodology and medical device terminologies will be useful.Objectives
The Clinical Evaluation Plan (CEP) is a key document that provides the foundation on which the clinical evaluation of a medical device is based. The objective of this workshop is to introduce participants to the regulatory requirements for this document and provide them with an understanding of how a well-written CEP can streamline the clinical evaluation process.Content
The workshop will provide a detailed overview of the contents of the CEP required under EU MDR. Specific topics covered include determining the clinical evaluation strategy best suited to your medical device, special considerations for legacy devices and new development, identifying appropriate safety and performance measures, identifying suitable equivalent or benchmark devices, the Clinical Development Plan, and an initial assessment of PMCF needs. The workshop will include group exercises and examples for low, medium, and high-risk class devices.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:15
PTA2
Professional Techniques - Advanced
Participant Profile
Delegates should include medical writers, particularly those who work within, or for, pharmaceutical companies; project managers (whether by actual title or function); and others with responsibility for overseeing and coordinating multifunctional projects. Participants should have at least 1 year’s experience working within a matrix environment.Objectives
• Acquire understanding of basic project management theory• Apply project management theory to multifunctional projects
• Broaden context beyond medical writing
• Add team-building strategies
Content
Discussion will include project management theory and practical applications, both within the context of a matrix organisation, and as an independent providing services to clients. A medical writing group may also adopt these practices to better control their own destiny.This workshop will be a combination of lecture and in-class exercise, and will include discussions based on analysis of the scenarios presented in the homework. While the majority of the presentation will be didactic, there will be opportunity for attendees to share their experiences and ask questions throughout the presentation.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Monday 7 November
to
12:15
PTF3
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
to
12:45
LWF21
Language and Writing - Foundation
Participant Profile
This workshop is for both native and non-native speakers of English who would like to write more clearly in English. Participants should have some experience of writing regulatory documents, peer-reviewed publications or patient material.Objectives
Medical writers worldwide need to convey scientific knowledge in technical documents, peer-reviewed publications or patient communications in clear, concise English in an increasingly time-pressed environment. Yet, many writers lack the skills to write English clearly, concisely and with the appropriate language and style. This workshop will provide specific writing tools and techniques that writers can apply to their writing to make their texts more precise and easy-to-read. After this workshop, participants will be more confident and better equipped to write more effectively in English.Content
The first part of this workshop will focus on precise word choice, sentence structure and tenses in medical writing. Participants will learn how to structure strong sentences in English and use specific techniques to self-correct their writing. The second part of the workshop will show how these language elements can be used to tell a story using concise and clearly constructed paragraphs and sections. Using guidelines and templates to facilitate story structures will also be discussed. Participants will be encouraged to participate actively in the workshop and will have the opportunity to practice the techniques learned.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: hrs
to
12:45
DDA27
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
to
16:30
DDF23
Drug Development - Foundation
Participant Profile
This workshop is intended for medical writers who are new to 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 laboratory data, vital signs and ECG data are generated and recorded during clinical trials and the subsequent handling of these data. On completion of the workshop package, participants should be confident in their approach to writing the laboratory and other safety data sections of documents relating to clinical trials, particularly clinical study reports.Content
The role of the medical writer in preparing summaries of safety data are 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 laboratory, vital sign and ECG 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 are 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 complement each other and provide an overview of presenting safety data.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 3:00hrs
Tuesday 8 November
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
to
12:15
PTF28
Professional Techniques - Foundation
Participant Profile
This workshop is aimed at medical writers looking to begin using Microsoft PowerPoint, or to refresh their basic skills.Objectives
The objective of the workshop is to give an overview of some of the functions of Microsoft PowerPoint, beginning from the very basics, and provide a practical guide to their use. There will be several hands-on exercises during the workshop for which a laptop with PowerPoint installed would be very helpful, although is not essential.Content
The workshop will begin with the basics of creating a new slideshow, adjusting slide formatting and using master slides, and inserting text and graphics. We will then examine the use of graphs for optimal display of data, animations and how best to animate graphs to enhance the presentation of scientific data, and tips and tricks for efficient and tidy slide design.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:00hrs
Wednesday 9 November
to
MDF9
Medical Devices - Foundation
Participant Profile
This course is intended for medical writers with little experience in regulatory writing.We will assume that participants have basic knowledge of the directives and regulations governing medical devices, such as the MDD and MDR. (Reading about these regulations will be part of the pre-workshop assignment.)
Objectives
The State of the Art has become the strategic kick-off of any medical device evaluation. It includes information about the medical background, clinical conditions, and alternative therapies related to a medical device. In addition, the State of the Art section needs to identify benchmark devices, which are the foundation to define parameters for safety and performance, the risk-benefit profile, and respective acceptance criteria. Separate systematic literature searches are required to identify relevant background information and benchmark devices.Although the term “State of the Art” is mentioned several time in the EU Medical Devices Regulation 2017/745, and Notified Bodies pay special attention to this issue, there is a lack of clear definitions.
Understanding the relevant parts of a State of the Art section and knowing where to start can be challenging, especially when writing your first Clinical Evaluation Reports.
Also, as a medical writer, you may face devices with little background information for which the literature search can become a challenge.
Finally, the State of the Art section is subject to regular updates and will also be included in other documents, such as the Summary of Safety and Clinical Performance (SSCP).
This workshop will give you profound insights into the regulatory requirements for the State of the Art, best practice recommendations on how to structure your search, and how to identify your benchmark devices and parameters.
Content
- Regulatory framework: EU MDR 2017/745 requirements and definitions- Content and structure of the State of the Art
- Systematic literature searches for the State of the Art
- Benchmark devices and benchmark parameters for safety and performance
- How to compare the State of the Art information to the subject device
- Review cycles and updates
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
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
to
12:45
DDF33+34b
Drug Development - Foundation
Participant Profile
This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).Objectives
The objective of this workshop is to equip you with the essential skills required for the management and preparation of high quality CSRs. This includes in-depth sessions on both the writing of CSRs as well as their project management. The workshop will include group exercises and discussions so that participants can develop new skills attained and learn from each other’s experiences.This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the production of CSRs.
Content
The course will cover:• CSR project preparation and timelines
• Writing a CSR according to International Conference on Harmonisation (ICH) E3 guidelines and CORE reference
• Writing the methods sections: brief overview and advice
• Interpreting data, describing results: demography and baseline characteristics
• Interpreting data, describing results: efficacy; using the statistical report
• Interpreting data, describing results: safety and safety narratives
• Different types of CSRs: abbreviated CSR, full CSR, post-marketing reports, medical device reports
• CSR review and quality control
• Appendices: an overview
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
DDF38d
Drug Development - Foundation
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
Thursday 10 November
to
12:15
PTF21
Professional Techniques - Foundation
Participant Profile
This workshop is aimed at medical writers who deal with health-related quality of life instruments (HRQoL) or patient-reported outcome measures (PROMs) in clinical studies or document writing. No prior experience with HRQoL instruments is needed.Objectives
The workshop will give an overview of the different types of HRQoL instruments and the main issues to be considered when using these measures in clinical studies. Participants will gain an understanding of how to appraise HRQoL measures and report their use in studies. We will also explore various approaches for generating the HRQoL data that are used in cost-utility analysis.Content
1. What is HRQoL and how can it be measured? (e.g. generic vs. specific, profile vs. preference-based measures)2. Reporting standards for HRQoL data (CONSORT-PRO and Chassany et al.)
3. Methods for generating preference-based value sets for use in cost-utility analysis and some of the challenges that arise.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
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.For 2021, we will focus on mentoring virtually.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
to
12:45
DDF33+34b
Drug Development - Foundation
Participant Profile
This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).Objectives
The objective of this workshop is to equip you with the essential skills required for the management and preparation of high quality CSRs. This includes in-depth sessions on both the writing of CSRs as well as their project management. The workshop will include group exercises and discussions so that participants can develop new skills attained and learn from each other’s experiences.This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the production of CSRs.
Content
The course will cover:• CSR project preparation and timelines
• Writing a CSR according to International Conference on Harmonisation (ICH) E3 guidelines and CORE reference
• Writing the methods sections: brief overview and advice
• Interpreting data, describing results: demography and baseline characteristics
• Interpreting data, describing results: efficacy; using the statistical report
• Interpreting data, describing results: safety and safety narratives
• Different types of CSRs: abbreviated CSR, full CSR, post-marketing reports, medical device reports
• CSR review and quality control
• Appendices: an overview
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
MCF30
Medical Communication - Foundation
Participant Profile
This workshop is intended for medical writers of all levels and specialties. Prior experience as a medical writer is not required; the concepts covered in this workshop can be helpful to even the most experienced medical writers.Objectives
Many medical writers, especially people new to the field, have difficulty coming up with a clear focus for their projects and developing them into a coherent document that accomplishes its objectives. In this workshop, we will provide a structured approach to conceptualizing, progressively building, and managing the development of medical writing deliverables.Content
Attendees will learn how to formulate a concise concept for their document using the problem statement approach. They will then learn to progressively develop the document from one or more outlines through different full drafts and the final version. The workshop will also cover how to manage the process within a collaborative team to increase efficiency and avoid pitfalls. It will include a combination of lectures, exercises, and discussionsPre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
PTA15
Professional Techniques - Advanced
Participant Profile
Regulatory medical writers involved in coordinating document review as well as those interested in establishing and improving best document review practices with their clinical teams or their organisations. Familiarity with the general principles of clinical development and regulatory documents (including clinical CTD modules, e.g. Module 2.7 Clinical Summaries and Module 2.5 Clinical Overviews) is assumed.Objectives
To give participants practical, easy-to-implement solutions that they can1) integrate during lead writer coordination of review cycles and 2) use to establish and improve review practices with their clinical teams or organisations. Participants will learn how to better clarify review expectations and systematically train reviewers to ensure a smooth collaboration, whether working on individual documents or establishing and improving organisation-level processes.
Content
This will be a highly interactive workshop with a lot of practical advice, discussion and group exercises. This workshop will:· provide practical advice on how to coordinate review cycles by training reviewers;
· identify common problem areas in the review of regulatory documents;
· define review, highlighting features of an effective review for developing fit-for-purpose documents, in contrast to cases when no review training is offered;
· present types of review and discuss how a review changes by document type/purpose, document review stage, and the reviewer’s functional role;
· provide specific examples of bad review comments and how to improve them;
· provide practical advice on how to best set up review processes (including advice on timelines, reviewers, comments resolution meetings, and electronic tools) and create a long-lasting “review culture” shift;
· provide a “reviewer’s checklist” that regulatory medical writers can use in their future cross-functional trainings on effective review practices.
Pre-Workshop Assignment Length: 1:15hrs
Post-Workshop Assignment Length: 2:00hrs
Friday 11 November
Participant Profile
This workshop is intended for scientific/medical writers with little or no background in virology, or those interested in refreshing or updating their knowledge on the fundamentals of the subject. It is particularly relevant for writers working in such areas as infectious diseases, vaccines, and immunology. Participants should already have a basic understanding of molecular biology (DNA - RNA - protein).Objectives
To enable writers to understand and appreciate the basic principles of virology, and how these principles are applied in the medical sciencesContent
The workshop will cover the following topics:· Brief history of virology
· Relevant virology terminology
· Structure and function of viruses
· Viral diseases and their prevention and control
· Emerging topics: Corona vaccines and therapeutic applications of virology
Pre-Workshop Assignment Length: 0:30hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:45
MCA8
Medical Communication - Advanced
Participant Profile
Anyone who wants to learn more about value messages and writing value dossiers, whether they are new to these topics or have some experience with them. The workshop will not assume any prior knowledge of value dossiers or market access, but will assume a basic familiarity with drug development and clinical data.Objectives
After completing the workshop, you should understand the concept of ‘value’ and be able to construct a value story and value messages for a pharmaceutical product or medical device. You will be familiar with the structure of a typical value dossier and have an understanding of what information is required in each section. You will understand what a value dossier is used for and how to make sure it fulfils users’ needs.Content
Obtaining marketing authorisation is no longer the final step in a drug’s journey to market. Manufacturers must also persuade budget-holders (payers) in each country to pay for it. The global value dossier (also known as core value dossier) is a key resource for pharmaceutical company market access teams. The workshop explain the concept of ‘value’ as it applies to pharmaceutical market access. It will emphasise the importance of the ‘value story’, and participants will learn how to create evidence-based ‘value messages’ (i.e. the claims that are used to show the product’s clinical, humanistic and economic value). The workshop will then describe the structure of a typical value dossier and guide participants through the information that goes into each section, and where to find it. The emphasis throughout will be on ensuring that the document meets the needs of its end-users.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:30hrs
to
17:00
MCA4
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-centred 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. Other topics are MICOT (material, investigative approach, comparator, outcome and timing) and a 6-step publication-planning-and writing process.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:30hrs
to
17:00
DDA32
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 and writing DSURs.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
Saturday 12 November
Participant Profile
Medical writers with at least 1 year of experience in the pharmaceutical industry.Objectives
• Learn what the ICH and regulatory guidelines say about the Investigator’s Brochure (IB)• Learn useful tools and advice for the actual writing, compiling, and managing of an IB project
• Experience the dynamics of team writing and editing as it pertains to an IB
Content
The IB is definitely the poor cousin among regulatory documents in the pharmaceutical industry. It rarely gets the resources and time required to do it properly. It can also be the bane of the medical writer’s life, as ‘quick update’ projects often turn out to involve excruciating re-formatting and consistency checks. In the first part of the course, participants will learn the ‘theory’ of IB writing, i.e. what the ICH and regulatory guidelines say, as well as tools to be used in successful IB writing gleaned from the extensive experience of the workshop leader. In the second part of the course, participants will work in teams to prepare a mini-IB based on actual data and compare their results to those of the other teams.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
MDF5
Medical Devices - Foundation
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
to
19:30
LWA12
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 14 November
to
12:45
DDA14c
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
Friday 18 November
to
17:00
PTA11
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
to
17:00
PTA3c
Professional Techniques - Advanced
Participant Profile
The workshop is for everybody who has come into contact with the statistical technique of Kaplan-Meier survival analysis and who wants to know more about what it means. Ideally you should have encountered such analyses in the context of clinical trials.Some minimal statistical understanding is needed and terms like ‘median’, ‘mean’, ‘confidence interval’, ‘risk’ , and ‘p-value’ should not terrify you.
Objectives
The objective is to acquire a basic understanding of Kaplan-Meier analyses and to be able to interpret the resulting graphs.Content
The workshop will give participants an understanding of the analysis of survival in the context of clinical trials. We will learn the basics of creating and interpreting Kaplan-Meier graphs and the different elements of reporting Kaplan-Meier analyses. The appropriate graphical and tabular presentation of these analyses will be discussed, but always the focus will be on the interpretation. There will be a few group exercises during the course.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs