56th EMWA Conference - Virtual
13-24 November 2023
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.
Monday 13 November
Participant Profile
This seminar is provided free-of-charge and is aimed at those considering a career in medical writing. It is open to conference delegates and members of the general public. It will also be interesting to those who have recently joined the profession who would like to know more.Content
In addition to giving a presentation covering all aspects of medical writing, the seminar leader will act as a facilitator to optimise exchange of experience between participants, as well as providing insight based on her expertise in this area.The aim is to provide information on the following:
• Definition of medical writing and its different categories
• Role of the medical writer throughout the life-cycle of a pharmaceutical product
• Explanation of the different types of documents that we write with detailed information on some of the most common (e.g. clinical study protocols and reports, investigator brochures, CTDs, manuscripts, posters)
• Timelines and project management
• Finding a job as a medical writer (qualities and qualifications required), types of companies that employ medical writers, recruitment process, working as a freelancer
• Training and networking for medical writers
Members of the public who wish to attend the seminar should approach the EMWA Staff at the Conference registration desk who will issue them with a temporary badge and direct them to the seminar room.
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
16:30
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
Tuesday 14 November
to
12:15
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
12:45
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
Wednesday 15 November
to
12:45
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
17:00
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
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
Thursday 16 November
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
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
Friday 17 November
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
12:45
MDF2a
Medical Devices - Foundation
Participant Profile
This workshop is primarily intended for medical writers who have some knowledge of regulatory guidance and are interested in working with medical devices. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.Objectives
The aim of this workshop is to understand the EU regulatory pathways, to become familiar with the documents used for medical devices to see these in the light of those used for pharma, and to identify transferable medical writing skills between pharma and medical devices.Content
The workshop will compare and contrast Pharma vs Medical Devices with respect to· definition of terms
· product development steps
· EU regulatory pathways, guidelines and requirements
· documents
· medical writing transferrable skills
Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
MDA3
Medical Devices - Advanced
Participant Profile
Participants should have a good understanding of clinical evaluations for medical devices and should have experience in writing clinical evaluation reports. There are no prerequisites, but participants might benefit from obtaining medical device workshops (CEP, CER, SOTA). There is no need for experience with Medical Device Software.Objectives
The workshop will give an introduction into the regulatory framework of Medical Device Software in Europe (MDR 2017/745). Participants will learn about the specific considerations for the clinical evaluation for Medical Device Software.Content
The workshop will cover the regulatory framework in the European Union for Medical Device Software, classification rules, and specific considerations for the clinical evaluation report and the State of the Art Evaluation. We will take an in-depth look at how to discuss technical performance, valid clinical association, and clinical performance of Medical Device Software in the clinical evaluation. The workshop will be interactive with team exercises and discussions.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
Saturday 18 November
to
12:15
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
to
12:45
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
to
16:30
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
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 20 November
to
12:15
MCF22
Medical Communication - Foundation
Participant Profile
This workshop is suitable for participants looking to improve their skills in the development of medical communication materials for scientific oral presentations. Previous experience in this area is not required; participants will benefit from this workshop whether they are already working in medical communications and would like to improve their skills, or are looking to move into this area.Objectives
The objective of the workshop is to equip participants with the skills necessary to produce effective oral presentations, whether working on behalf of clients or authors, or looking to improve their own presentations. The workshop will consider the purpose of presentations as a means of communicating scientific findings, and how this can best be achieved through the use of effective data presentation and slide layout, and eye-catching visuals. Best practice and approaches to project management will also be discussed.Content
Through a mixture of lectures, interactive group activities and group discussions, participants will learn:· Efficient and striking ways of presenting data
· How to prioritise information to avoid over-crowding a presentation
· Practical approaches to managing presentation projects and the development process
· How to gain maximum engagement from presentation attendees, and communicate the key messages
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:00hrs
to
12:45
DDA26
Drug Development - Advanced
Participant Profile
Medical writers who would like to gain advanced knowledge about RMP and PSUR assessment processes and the role of the medical writer after document submission in Europe. Participants without hands-on experience with RMPs and PSURs should in advance attend the courses DDA14a, DDF30, or DDF32.Objectives
This workshop will explore medical writing tasks from first submission onwards and throughout the lifecycle of the medicinal product. Participants will learn how to handle authority requests and parallel RMP and PSUR preparation.Content
RMPs are prepared for new marketing applications. Within the authorisation procedure and also later on, throughout the lifecycle of the medicinal product, the RMP may have to be updated to always reflect the most current knowledge on the product’s risk profile. After marketing authorisation, PSURs will be prepared. The assessment of PSUR and RMP may often impact both documents and requests may have to be addressed at the same time and within short timelines.The medical writer provides guidance to the product teams and plays a central role throughout the submission and assessment procedures of RMPs and PSURs.
The workshop will cover a variety of pharmacovigilance writing activities between RMP submission and closing sequence (e.g., responses to authority questions, RMP updates),will explore PSUR evaluation procedures, and the impact of PSUR assessment on the RMP (e.g., addressing assessment report requests in the next PSUR and/or RMP).
We will guide participants through possible scenarios and address typical questions and pitfalls.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
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
Tuesday 21 November
to
12:45
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
to
12:45
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
Wednesday 22 November
to
12:45
DDF38a
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
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
DDF36a
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
Thursday 23 November
to
17:00
DDF41
Drug Development - Foundation
Participant Profile
This workshop is aimed at new medical writers and experienced writers who are new to writing clinical study protocols.Objectives
The purpose of this workshop is to introduce medical writers to the components and concepts of a protocol, and to provide instruction on protocol writing. On completion of the workshop package, participants should feel confident about how to develop and write a protocol and how to manage the process.Content
The workshop will explain how to develop a protocol with practical examples and exercises. Participants will be introduced to the role of the study team in protocol writing. An outline will be given of regulations, guidelines, and sources of information. The pre-workshop assignment will be reviewed and used to build up a picture of the study. The influence of the study design on the protocol will be discussed. Development of the protocol synopsis will then be examined in detail, including discussion of study design and the relationship of the protocol with the Case Report Form.The workshop will then focus on the body of the protocol, i.e. filling in the details, including how to ensure that the study will be conducted as intended. This will be supplemented by the interactive workshop exercises, which are designed to get participants thinking in logical, practical sequence. The last part of the workshop will describe the ‘standard’ and administrative sections, appendices, and the ‘When, Why and How?’ of protocol amendments.
The workshop will then focus on the body of the protocol, i.e. filling in the details, including how to ensure that the study will be conducted as intended. This will be supplemented by the interactive workshop exercises, which are designed to get participants thinking in logical, practical sequence. The last part of the workshop will describe the ‘standard’ and administrative sections, appendices, and the ‘When, Why and How?’ of protocol amendments.
Pre-Workshop Assignment Length: 3:00hrs
Post-Workshop Assignment Length: 3:00hrs
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
Friday 24 November
Participant Profile
As professional medical writers should be reporting guideline champions, this workshop is propaedeutic for any workshops on scientific journals or congresses publishing and highly helpful for regulatory writers.Objectives
The growing availability of guidelines and checklists makes identification and use of the most appropriate guidelines for any specific disclosure more difficult. This workshop will help the writer to identify what is available and understand how to choose and use the most appropriate guidelines for their purpose.Content
The Consolidated Standards of Reporting Trials (CONSORT) statement, issued in 2001, was the first example of a comprehensive and structured guideline on how to communicate the results of randomised clinical trials. In addition, different guidelines, and checklists to use for the results of observational, health outcome, quality of life, mixed-method, and many other types of studies have been published. To complement all of these, pharmaceutical companies have developed Good Publication Practices, individual editors have developed their guidelines, and most journals have their own instructions for authors. In this workshop, we will review the main guidelines to identify when and how they can be used by medical writers to improve the productivity and quality of their jobs.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:45
MDA2b
Medical Devices - Advanced
Participant Profile
This workshop is intended for medical writers with regulatory writing experience who are either interested in working with medical devices or who already work with medical devices and are involved in preparing clinical evaluation reports (CERs). Familiarity with the medical device regulation (MDR) 2017/745 and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. Prior attendance at the Introduction to Writing for Medical Devices or From Pharma to Medical Devices workshops would be helpful but is not essential.Objectives
The aim of this workshop is to understand how to write a CER, in particular for higher risk medical devices. Participants will learn how to prepare a CER to MDR standards with reference to the MEDDEV 2.7/1 rev. 4 guideline. Note that conducting a clinical literature review, defining the state of the art and post-market clinical follow-up (PMCF) are only briefly presented in this CER workshop as they are the subject of separate workshops.Content
The workshop will explain the following:Introduction to medical device regulation and market approval process;
Clinical evaluation process;
Clinical evaluation plan;
Clinical evaluation report;
Device under evaluation;
Literature review – current knowledge, state of the art, clinical literature;
Preclinical and clinical data;
Clinical investigations;
Claims
Risk assessment – benefit/risk;
Post-market surveillance (PMS) including PMCF.
The workshop will include group exercises and discussions.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 3:00hrs