58th EMWA Conference - Virtual
November 2024
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 here. You do not need to wait for further instructions from the workshop leader.
Times below are CET.
Tuesday 12 November
to
13:00
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
Participant Profile
This course is intended for advanced medical writers with experience in regulatory writing and PMCF.We will assume that participants have good knowledge of the Medical Devices Regulation and the requirements for Post-market Clinical Follow-up.
Objectives
The requirements for Post-Market Clinical Follow-up (PMCF) as part of Post-Market Surveillance (PMS) under the MDR are well-known and most medical device manufacturers have robust procedures in place. However, selecting the right PMCF activity for a medical device, considering the available clinical evidence, device classification and market history, remains a challenge. User surveys are often associated with low response rates, PMCF studies are sometimes conducted with inappropriate endpoints, and registries might provide incomplete information. Therefore, it is crucial to identify the most suitable PMCF method right away to save time and costs.The workshop will briefly review the PMCF requirements under the EU MDR 2017/745 and will then dive into different methods to collect clinical data in the post-market phase. This includes user surveys, different designs for PMCF studies, registries, or electronic health records. Participants will have the chance to work on several case studies to learn how to select the ideal PMCF activity for medical devices with different requirements regarding the expected clinical evidence.
Content
● Short introduction to Annex XIV Part B of EU MDR 2017/745 (Post-Market Clinical Follow-up)● User surveys:
o Best practice tips to plan and set up a user survey
o Case study
● PMCF investigation:
o Common pitfalls with PMCF investigation plans
o Case study
● Additional PMCF activities: device registries, electronic health records, social media listening
● Practice with a fictional medical device
Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:00hrs
Participant Profile
This workshop will benefit medical writers who have an interest in the clinical development of orphan medicinal products, and who are familiar with the European Medicines Agency marketing authorisation application (MAA) procedures. Prior attendance to DDF13 Basic Concepts of Study Design in Clinical Development would be helpful but is not essential.Objectives
To provide participants with an understanding of how to prepare the scientific part of an orphan designation application and to recognise strategies used in clinical development of an orphan medicinal product.Content
Orphan medicinal products are intended to treat rare diseases, and the pharmaceutical industry are eligible for a number of incentives if they develop these products. However, a medicinal product cannot be granted orphan designation unless orphan designation is approved by the European Commission, and an approval of orphan designation is not a guarantee for a successful marketing authorisation. Clinical development of orphan medicinal products is often complex because rare diseases are poorly characterised and under-researched at the time of development, and only affect a small percentage of the population. This workshop will provide an overview of orphan medicinal products, rare diseases and incentives; provide an overview of the orphan designation procedure; provide guidance on how to prepare a comprehensive orphan designation application (scientific part); and provide strategies for clinical development in orphan medicinal products. As protocol assistance is an incentive granted for orphan designation, an overview of the procedure will also be covered.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 3:00hrs
Wednesday 13 November
to
13:00
DDA19
Drug Development - Advanced
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
to
17:00
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
Thursday 14 November
to
13:00
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
to
13:00
DDF36b
Participant Profile
This basic workshop is intended for participants directly or indirectly involved in the planning, analysis and/or reporting of clinical trials, or in the design of clinical development programs, or those with little or no background in this area who are interested in learning the basics. Previous experience or background knowledge of clinical trial disclosure is not required. This workshop will benefit newcomers to the topic, but also those simply wishing to update their knowledge of this topic.Objectives
Attending this workshop will help participants to understand the regulatory requirements (e.g., EMA Policies 043 and 070, the EU Clinical Trials Regulation [EU CTR], and national Freedom of Information laws) and industry commitments for clinical trial disclosure, understand how patients and investigational sites may benefit from this disclosure, be introduced to the new documents required due to the disclosure (EMA Policy 070 anonymization report, protocol lay synopsis, lay summaries, etc.), be aware of the challenges created by clinical trial disclosure for when drafting clinical documents (e.g., protocols, clinical study reports), understand what is company confidential information, personal protected information, and data privacy, and understand how data privacy and confidential information is protected (e.g., using anonymization or redaction).Attending this basic workshop before attending one of the specialist workshops will enable participants to gain the most benefit from the advanced workshops.
Content
This will be an interactive workshop combining classical presentations with quizzes and exercises to introduce the topic. The aspects of clinical trial disclosure most relevant for medical writers, including potential new deliverables and challenges during protocol and CSR writing, will be highlighted. This workshop will enable attendees to embark upon workshops covering specialized topics such as the drafting of lay summaries, trial registration and results reporting in EudraCT/CTIS/clinicaltrials.gov, and the protection of protected personal data and commercially confidential data.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:00hrs
to
17:00
MCF33
Medical Communication - Foundation
Participant Profile
Participants should be broadly familiar with the types of “traditional” publications – abstracts, posters, oral presentations and manuscripts. No previous experience in developing or using enhanced content is necessary.Objectives
This workshop aims to educate attendees on the most commonly utilised forms of enhanced content available to accompany traditional publications (e.g. author interviews, animated summaries, graphical abstracts, plain language summaries) and discuss how these can be incorporated into the project flow.Content
The workshop will give an overview of the various types of enhanced content that could be developed to accompany a publication, when these might be appropriate and the benefits and drawbacks of each. We will also discuss aspects of project management when developing these materials, common barriers to their uptake and discuss approaches to overcome these.Please note that this workshop will not teach specialist techniques used to physically develop the materials (e.g. use of any specialist design software).
Pre-Workshop Assignment Length: 0:30hrs
Post-Workshop Assignment Length: 2:00hrs
Friday 15 November
to
13:00
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
Participant Profile
This workshop is intended for medical writers (and others) who are interested in research and development of new medicines, and how decisions are made about how these are provided to patients. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical research, healthcare, and medical ethics will be provided for interactive discussion.Objectives
To give an overview of the various ethical considerations associated with conducting clinical trials, and associated policies and processes, including institutional oversight, pre-approval access, regulatory authority clearance, subject informed consent, investigatory conflict of interest, issues of fraud, and ensuring subject safety and well-being.Content
This workshop will consist of a combination of presentations on the evolution of ethical principles associated with human subject participation; relevant ethical issues, with respect to clinical research and development, clinical trials, societal healthcare decisions; and group discussions on challenging ethical considerations of some “real-world” case studies. The presentations will focus on the importance of ethics in GCP, human subject protections, and the dynamic tension between the individual and societal needs. Practical experience will be shared with the participants.Pre-Workshop Assignment Length: 3:00hrs
Post-Workshop Assignment Length: 2:00hrs
Saturday 16 November
to
12:30
MCF32
Medical Communication - Foundation
Participant Profile
This workshop is aimed at medical writers who are at an initial stage of their career or those who want to learn more about how to handle advisory boards in the most effective way. No prerequisites needed, however this will be an interactive workshop and exchange of experiences with each other.Objectives
The objective of this workshop is to help plan, organize, moderate and report an advisory board. There is not much offer on this subject and there is a growing request from medical writers in consolidating and growing their knowledge on advisory boards.Content
We will be covering the different stages of an advisory board, from both the perspective of the organizer (usually a pharma client) and its management (usually an events/med comms agency).From the organizer perspective, we will focus on the needs assessment (why the advisory board is needed, who the audience is, what are the main objectives and desired outcomes).
Then we will share some content about the organization (timelines, invites, preparation of presentations, pre reads for the attendees, the advisory board itself)
And finally, the role of the medical writer: moderation, reporting and delivering a report/executive summary.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
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
16:30
MDF10
Medical Devices - Foundation
Participant Profile
This workshop is aimed at medical writers working in the regulatory field. Basic knowledge of regulations governing medicinal products and medical devices will be useful. Having completed the workshop Going from Pharma to Medical Devices would be helpful but is not a prerequisite.Objectives
The objective of this course is to provide an introduction to the regulations governing combination products (with focus on drug-device combinations [DDCs]) as they are defined in the US and EU, respectively. Additionally, we will touch on the documentation required for these types of submissions and the role of medical writers in developing these documents.Content
Combination products are regulated differently depending on their “Primary Mode of Action (PMOA),” their product configuration, and the regulatory body. Understanding how a combination product is regulated will be essential in understanding the documentation required in the regulatory submission. In the US, the submission process is different compared to that in the EU – however, much of the content is already an existing part of the technical documentation of the device and drug component, regardless of jurisdiction.This workshop will provide an introduction to combination products and the different types. We will cover the parts of a US submission and an EU submission, depending on the combination product PMOA, that are relevant to medical writing.
A few case-studies will be presented and discussed.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 3:00hrs
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 18 November
to
12:30
DDF54
Drug Development - Foundation
Participant Profile
The non-clinical study report (NCSR) is a comprehensive document that presents the findings and results of studies conducted on substances or products in preclinical or laboratory settings. Hence, those who stand to benefit from this workshop are regulatory personnel and scientific/medical writers in the pharmaceutical industry, those at CROs or medical writing agencies involved in regulatory documentation, or within academic groups/technology transfer departments at universities, etc.Participants of this workshop will be expected to have basic experience/knowledge of the drug development and approval process in the US and/or the EU, as well as familiarity with various components of the eCTD.
Objectives
Participants of this workshop will receive an overview of the regulatory guidelines and individual parts of the NCSR and relevant source documents, as well as submission requirements. Thereby, the medical writer’s role in the preparation of the NCSRs will be highlighted.Content
Non-clinical studies are a crucial element of the drug development process and are typically performed before any testing on human subjects (clinical trials). Non-clinical study reports summarise the development, safety, efficacy, and potential risks associated with a substance or product under investigation.The main focus of the workshop will be to clarify the medical writer’s role in the selection and assembly of relevant source documents when preparing an NCSR.
The workshop is planned to be interactive and will include discussion of participants’ questions submitted in their pre-workshop assignments as well as group activities throughout the workshop.
Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:30hrs
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
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
Tuesday 19 November
to
13:00
DDF30
Drug Development - Foundation
Participant Profile
Aimed at medical writers with little or no experience of writing risk management plans (RMPs), but with a basic knowledge of the overall drug development process and some experience in assessing and presenting non-clinical and clinical data on drug safety and risks. Ideally, participants with no knowledge in pharmacovigilance should attend the foundation workshop on pharmacovigilance writing (DDF32) prior to register to this workshop. Writers with more experience of RMPs should consider EMWA’s advanced workshop on the topic, DDA20.Objectives
To learn about the structure, content and requirements of RMPs according to the ‘EU Pharma Package’, which came into force in July 2012. At the end of the workshop, participants will be able to understand the focus of RMPs, identify the right content and language for each section, and collecting informations to prepare an RMP.Content
This workshop will provide an overview of the preparation of RMPs according to Good Pharmacovigilance Practice (GVP). Participants will learn where to find relevant guidance and which source documents should be used while preparing RMPs within multidisciplinary teams. The most relevant drug safety concepts for RMPs (e.g. important identified and potential risk) will be explained, then the structure and content of the RMP will be presented and selected issues will be explored in exercises. Emphasis will be given to the focus, content, and data presentation of different RMP sections.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
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
DDA35
Drug Development - Advanced
Participant Profile
This workshop is ideal for medical writers with experience in creating documents for regulatory or non-specialist readers. It is especially beneficial for medical writers involved in developing informed consent materials for potential study participants. Medical writers who may need to produce written information in lay language about the safety and contraceptive aspects of a drug in clinical research will find this workshop particularly useful. Ideally participants understand an investigator brochure and of a clinical trial protocol.Objectives
The purpose of the Informed Consent Form (ICF) is to provide potential study participants with a clear summary of the risks involved in the study. This information should be written in easy-to-understand language so that participants can make an informed decision whether to participate in a clinical trial. It is essential for project and trial teams in clinical research to regularly update this information. Medical writers with expertise in regulatory and lay language writing can contribute valuable skills in developing and updating the risk information.The goal of this workshop is to help participants gain a comprehensive understanding of the language, templates, processes, and tools needed to effectively develop and update safety and contraception information in lay language for informed consent purposes.
Content
The safety and contraception content in an ICF will be presented and discussed. There will be particular emphasis on the development of reproducible and harmonized side effect and contraception information. Other topics include recommended lay language terminology, tools, and process considerations.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:30hrs
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
Wednesday 20 November
to
13:00
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
13:00
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
to
17:00
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
17:00
MCF34
Medical Communication - Foundation
Participant Profile
This workshop is designed for anyone in medical writing who wants to improve their skills in visual communication using infographics. No previous knowledge or workshop is required, some experience in design would be helpful but is not essential. All the software will be given during the workshop so there’s no need to buy any license as we will work with free tools.Objectives
The ability to communicate scientific and medical topics visually gives any medical writer an advantage and a chance to collaborate on a variety of projects and improve their portfolio. Given the emergence of new technologies, it is important to gain tools that cannot be easily replaced by AI. Infographics and complex displays of information including images are not yet easily achieved by this type of technology, positioning medical writers with visual communication skills in a more competent place.Content
This workshop will cover the process from the storytelling to the design of the infographic to effectively deliver the message. In the beginning, we will introduce concepts to define the audience and the goal. When the idea and message are clear, we will start with the design of the infographic layout, placing the different elements correctly; in this part, we will introduce design concepts, the idea of repetition, hierarchy, colour, and balance. We will use different free tools for design and illustration. The main goal of this workshop is to understand the process of building an infographic as a layer system. First, the message and the layout, disposition of the different concepts or topics we want to deliver; followed by finding the colours, fonts, and proper illustrations. We will also discuss resolution and different formats (RGB, CMYK) depending on the use of the infographic.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Thursday 21 November
to
12:30
DDF53
Drug Development - Foundation
Participant Profile
This workshop would benefit all medical writers currently working in regulatory writing. There are no prerequisites for this workshop.Complementary EMWA workshops include: How to Manage your Writing Project (PTF29), Interpersonal Skills for Medical Writers (PTA12), Establishing Effective Review Practices for Regulatory Documents (PTA15), and Building Medical Writing Teams (PTA14).
Objectives
In addition to the task of medical writing we are more and more frequently called to author documents in a more collegiate atmosphere, writing directly as part of a team who all have access to the working document during drafting. This workshop aims to equip the regulatory medical writer with the understanding and skill sets necessary to manage and work optimally within teams in this collaborative fashion. This workshop will help regulatory medical writers realise the advantages of writing collaboratively and develop the soft skills to successfully orchestrate a group of collaborators.Content
In this workshop we will cover:· Why we are moving towards collaborative authoring and what this means for the medical writer
· Optimal strategies for planning and commencing a collaboration project
· How to effectively use the expertise of your team
· How to assess and manage your collaboration team
· How to achieve agreement during authoring to optimise review cycles
· The technical tools: different means of collaboration
· How to overcome fear: understanding the technical process and optimising the document production cycle
· Learning from each collaboration project and improving the next one
Pre-Workshop Assignment Length: 0:30hrs
Post-Workshop Assignment Length: 0:30hrs
to
13:00
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
16:30
MSF9a
Medical Science - Foundation
Participant Profile
This workshop will give a basic understanding of genetic principles to any writer who may need to understand or write about pharmacogenetics or genomics, or with an interest or curiosity in the field. It will also be useful revision for anyone who has not been involved in the area for some time. No prior knowledge is necessary. Participants may find this a useful preparatory workshop for MSF4, Pharmacogenomics, at future conferences.Objectives
An understanding of genetics is becoming increasingly important in the pharmaceutical industry as the sciences of pharmacogenetics and pharmacogenomics grow and influence most aspects of drug research and development. As professional communicators, it is vital that medical writers have a basic understanding of genetics to be able to communicate the latest research and its effects correctly and effectively to regulators, healthcare professionals and even patients. Unfortunately, this area of science is often explained poorly or confusingly, and academic research papers assume a certain level of genetics knowledge. This workshop is intended to give a grounding in genetics, to explain basic genetic terminology and nomenclature, and to introduce writers to genetic research. The aim is that participants will be equipped to both cope with more advanced workshops involving pharmacogenomics, and to understand and interpret genetics research more easily.Content
Participants will be led through the basics of inheritance, from the behaviour of DNA in cell division, through to inheritance patterns and how these may be predicted. Advances in sequencing and advanced topics such as pharmacogenomics, medical genetics, and epigenetics will be mentioned but detailed descriptions are beyond the scope of this workshop. The correct nomenclature and syntax will be explained (e.g. how to differentiate between genotype and phenotype).Pre-Workshop Assignment Length: 0:30hrs
Post-Workshop Assignment Length: 2:00hrs
Participant Profile
This workshop is targeted towards medical writers whose native language is not English. Native speakers who encounter difficulties with the use of tense or who need to be aware of the difficulties experienced by non-native English writers in this area are also welcome.Objectives
Provide guidance for medical writers who are not native speakers of English on the effective use of tense in English scientific and medical texts.Content
The use of tense in English is a major problem area for medical writers whose first language is not English. This workshop will focus on the proper use of tense as a key element in meaning in our types of text. Examples of typical problems are distinguishing between the simple past and present perfect, choosing the right tense for generally valid statements, correctly applying different forms of present and future tenses, and the appropriate use of modal verbs. Based on the presentations and hands-on exercises, we will look at the different tenses used in different sections of study protocols, study reports and other documents typically prepared by medical writers. More exercises will show us how some tenses are more suitable when speaking and some more suitable when writing.For the pre-workshop assignment, participants will be required to submit particular problems with tense they encounter when working with medical documents in English. The workshop leaders will analyse and discuss selected topics from the participants’ pre-workshop assignments during the workshop. Exercises based on these examples will give participants the opportunity to discuss solutions amongst themselves and with the workshop leaders. The post-workshop assignment will consolidate the content of the workshop.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Friday 22 November
to
13:00
PTA16
Professional Techniques - Advanced
Participant Profile
This workshop is suitable for medical writers who have some experience in delivering oral presentations and want to reflect on or improve their oral presentation skills. Participants should find the workshop useful for a variety of situations: presentations to colleagues, pitching to potential clients for new business, training colleagues, or speaking at meetings. Participants should be confident communicating in English, particularly as they will deliver a short presentation in English. (We do not cover slide design and construction of a story, which is addressed in the workshop Developing Effective Oral Presentations, MCF22.)Objectives
· Appreciate that good preparation and rehearsal are key to successful delivery.· Consider how good presenters engage their audience: use of voice and body language.
· Learn how to deal with questions and challenging people.
· Handle presentation nerves.
· Gain practical experience and receive feedback by delivering a short presentation during the workshop.
· Constructively critique the short presentations delivered by other workshop participants.
Content
· What you need to know before preparing slides.· Managing equipment and the environment.
· Rehearsing and keeping to time.
· Increasing the impact of an oral presentation.
· Presentation nerves.
· Voice and body language.
· Questions and difficult people.
· Individual participant presentations.
Important
Each participant will deliver a short presentation (3 minutes) with up to 10 slides prepared during the pre-workshop assignment. Participants and workshop leader will give constructive feedback.
· The workshop is limited to 10 participants, allowing comfortable time for all presentations and feedback.
· For those who are worried – don’t be – you’ll be safe and it’s fun!
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
13:00
LWF22
Language and Writing - Foundation
Participant Profile
This workshop is aimed at improving the inclusive language sensitivity of medical writers. Previous attendance at another workshop is not required.Objectives
Why should equality be a priority for all of us? Genuine intentions are essential to tackle diversity—when the purpose is not genuine, one ends up with little more than tokenism or empty words.Equality and inclusive language go hand in hand. Inclusive language is complex and seeks to embrace diversity and treat all people with respect, dignity, and impartiality. What is more complex than diversity?
What nuances of inclusive communication should medical writers be aware of when drafting texts, and how to advocate for inclusive language among our peers and stakeholders?
This workshop will help you develop an eye for non-inclusive wording and provide tips and tricks to avoid non-inclusive and ableist language.
Content
· What is inclusive language?· Why is it important?
· What do regulations say about it?
· Key considerations when writing an inclusive text
· The impact Medical Writers have when using inclusive language
· Language processing models. Can AI-based tools help us in writing inclusive texts?
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
PTA19
Professional Techniques - Advanced
Participant Profile
This workshop is beneficial for Medical Communicators/Medical Writers (MW) who would like to move into the role of leader and manager to lead in regulatory writing project development, resource for specific documents, possibly still author, or manage teams and resource tasks within those teams.Objectives
This workshop will detail and enhance project teams' stakeholder and resource management when the MW is considered the lead in the production process. MWs will be in a position to better manage the projects that they are leading or resourcing following this workshop.Content
The workshop structure is proposed to examine different stages of regulatory document development, then move to programme level and finally, submission packages.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:30hrs
Saturday 23 November
Participant Profile
Anyone who wishes to explore how to recognise a cultural issue or problem (particularly in a medical writing setting) and how to approach it wisely. Curiosity and willingness to share own experiences are the most important prerequisites.Objectives
By raising awareness about cultural differences and key factors involved in intercultural communication, this workshop aims at giving participants an increased ability to recognise cultural issues in situations that medical writers frequently encounter, and the basic skills needed to avoid potential problems.Content
The ability to operate effectively in multicultural contexts has become a key business skill. Medical writers often work in international teams and many of us have experienced different working styles and ways of communicating that can create a host of problems. Knowledge about cultural characteristics and differences, and how they affect medical writing can diminish these problems. The workshop will be a mixture of lecturing, discussions and group work. The most common ways of distinguishing cultures from each other (national and organisational) will be covered and the pre-workshop assignment (the Enneagram’s nine personality types) will help to raise awareness about one’s own personal inclination to meet an unknown culture. Discussion groups will be put together from information given in the pre-workshop assignment.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:30hrs
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
Monday 25 November
to
12:30
MCF12a
Medical Communication - Foundation
Participant Profile
Researchers who wish to improve the likelihood of getting funds by increasing the quality of their grant applications, and medical writers who would like to assist researchers in writing and improving such applications.Objectives
To increase understanding of research funders’ expectations and priorities and learn how to translate ideas into strictly defined quantifiable projects.Content
Competition for research funding is increasing, and well-written grant applications can open or close doors for research careers. Crucial aspects of the workshop are how grant proposals stand out as unique documents and differ from other medical and scientific communication texts. We will introduce funding schemes from the Horizon Europe work program to exemplify different audiences and reviewer expectations. We will discuss differences between top down and bottom-up funding schemes, grant terms and concepts. The workshop will be focused on the unique sections in grant proposals; i.e. expected impact, dissemination plans and implementation of the proposed activities. Finally, we will discuss the grant evaluation criteria and the most common shortcomings pointed out by evaluation panels.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
13:00
PTF25b
Participant Profile
This workshop was previously run under the title 'Patient Registries as a Source of Medical Information’.This workshop addresses medical writers who prepare publications based on the data from research databases, patient registries and other real-life data sources. Basic knowledge of the design of observational studies, epidemiological research and statistics is not critical, but would be beneficial.
Objectives
To present the pros and cons of real-life research, to teach how to avoid over-interpretation of the study results, and to present these data effectively. Finally, to position patient registries as a complement to experimental studies.Content
Nowadays, real-life medical data sources such as research databases or patient registries are gaining in importance as a source of medical information, and medical writers are often involved in preparing manuscripts based on these data. However, it should be highlighted that the way these data are reported differs from the way the data from experimental trials are presented. This workshop focuses on the basic concepts of real-life medical research, the differences between the data from real-life settings and experimental trials, the ways of publishing them, and the issues medical writer must think of while writing such papers. Furthermore, it will present the overview of the main aspects of analysis and interpretation of the registry data, including specific statistical problems (but without going into mathematical details). The workshop will include examples of registries and relevant papers to illustrate the potential of this kind of research.Pre-Workshop Assignment Length: 2:30hrs
Post-Workshop Assignment Length: 3:00hrs
Participant Profile
Participant profile: new/aspiring medical writers who are interested in writing for medical devices, or experienced medical writers, who usually work in medical communications or in regulatory (drug development) and want to learn about medical devices. This is an introductory workshop, so the only ones who will not benefit from it are those who already work in medical devices and have an understanding of the processes and documents involved.Objectives
To give attendees an overview of what is a medical device, the classification rules, regulatory landscape (focusing primarily in the European Union), and the main documents that medical writers are involved with. The workshop will also explore the role of the medical writer, the necessary skills and possible challenges to overcome when working in the medical devices area.Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:00hrs