51st EMWA Conference - Virtual
May 2021
See Fees and Registration for details of fees and waiting list procedures for events (including EPDP workshops).
EPDP workshops
If you attend an EPDP workshop and successfully complete the pre- and post-workshop assignments you can gain an EPDP credit (2 for a double workshop), which can allow you to apply for an EMWA certificate of professional development. See the EPDP brochure for details. However, you are welcome to attend workshops without doing them for credit.
When you have registered for a workshop, download the pre-workshop assignment using the link on the right hand side of the workshop listing. You do not need to wait for further instructions from the workshop leader.
Saturday 8 May
to
12:45
DDA27
Drug Development - Advanced
Participant Profile
Participants should be familiar with the drug development process and have an understanding of basic pharmacokinetics and statistics. In addition, participants should have experience with clinical study reports and regulatory submission dossiers.Objectives
After completing the workshop, participants will have an understanding of the differences between biosimilars and NBE development. In addition, they will understand how these differences influence the development of clinical documents. They will appreciate the challenges they might face when working in this relatively new field of Medical Writing.Content
• General overview on biosimilars clinical development• Dealing with biosimilars clinical study reports (Phase I and Phase III)
• Dealing with the clinical documents of a biosimilars submission dossier
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
16:30
DDF20a
Drug Development - Foundation
Participant Profile
This workshop is intended for writers with little Good Clinical Practice (GCP) experience whose work involves clinical trial documents e.g. informed consent forms, protocols and reports.Objectives
An understanding of the principles of GCP and how they can be applied in the writing and reviewing of clinical research documents e.g. informed consent forms, clinical study protocols, and regulatory documents e.g. clinical study reports, clinical overviews and summaries.Content
The first part of the workshop will provide an overview of the principles of GCP, including the Declaration of Helsinki, the ICH E6 GCP Guideline, the EU Clinical Trial Regulation 536/2014 and ISO 14155:2020. The second part of the workshop will focus on how to ensure that documents are GCP-compliant, and the cross-checks that can be made, particularly when writing clinical study reports.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
Monday 10 May
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
MCA7
Medical Communication - Advanced
Participant Profile
This workshop is for medical writers who want to engage in the writing of lay summaries of study results as mandated by the EU regulation. Participants should already have an understanding of CSR structure (ICH E3) and should know the basics of clinical research (trial design, efficacy and safety analysis, basic statistics).Objectives
Writing lay summaries is a difficult and challenging task. Medical writers with an interest in lay writing are well suited for this new and upcoming activity. However, the provision of lay summaries requires a lot more than good lay language writing. The workshop will introduce the many different aspects of providing lay summaries: the available regulatory guidance, the positions of various stake holders (pharma and patient organisations), the intricacies of the actual writing of lay summaries, and considerations for appropriate distribution of the lay summaries.Content
The workshop will introduce the requirements for lay language summaries of study results according to the EU regulation. The various guidance documents from stakeholders (TransCelerate, MRCT, European Expert Group) will be introduced and briefly discussed. The content requirements for lay summary will be presented and possible solutions will be presented for discussion. As lay language writing is difficult, only the basic principles of plain language writing will be covered. To learn about the complexity of lay language writing in a confined context, the workshop will have a practical exercise, as participants will be asked to write a short paragraph of a lay summary. In addition, methods for patient involvement into the writing and review of lay summaries will be introduced and the various distribution options for lay summaries as well as the issue of translations will be discussed.Pre-Workshop Assignment Length: 2:30hrs
Post-Workshop Assignment Length: 3:00hrs
to
17:00
MDF1
Medical Devices - Foundation
Participant Profile
Medical writers with experience in medical communications or regulatory writing. Some experience and understanding of the regulatory requirements for the market approval of medicinal products is expected.Objectives
To introduce the field of medical devices and associated document requirements. Areas covered include: classification of medical devices, basic regulatory issues regarding the approval and marketing of medical devices, recent changes in regulatory requirements and how these impact the medical writer’s role, as well as some of the most common medical communication documents.Content
A syringe, a knee prosthesis, a computerised tomography (CT) scanner, an external defibrillator, and a pacemaker are all medical devices, but they belong to different risk classes. The new regulations (MEDEV rev. 4 and Medical Device Regulation) define a core documentation set required for regulatory compliance of these devices. And this can be challenging for the industry and the medical writer.Focusing on a set of different medical devices, the main elements of the workshop will introduce:
• What is a medical device and why and how they are classified
• Key documentation for regulatory compliance and market release of a medical device
• Medical communication texts: particularities for medical devices
The workshop will include group exercises and discussions as well as evaluations of real documents.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:30hrs
Tuesday 11 May
to
12:45
PTA15
Professional Techniques - Advanced
Participant Profile
Regulatory medical writers involved in coordinating document review as well as those interested in establishing and improving best document review practices with their clinical teams or their organisations. Familiarity with the general principles of clinical development and regulatory documents (including clinical CTD modules, e.g. Module 2.7 Clinical Summaries and Module 2.5 Clinical Overviews) is assumed.Objectives
To give participants practical, easy-to-implement solutions that they can1) integrate during lead writer coordination of review cycles and 2) use to establish and improve review practices with their clinical teams or organisations. Participants will learn how to better clarify review expectations and systematically train reviewers to ensure a smooth collaboration, whether working on individual documents or establishing and improving organisation-level processes.
Content
This will be a highly interactive workshop with a lot of practical advice, discussion and group exercises. This workshop will:· provide practical advice on how to coordinate review cycles by training reviewers;
· identify common problem areas in the review of regulatory documents;
· define review, highlighting features of an effective review for developing fit-for-purpose documents, in contrast to cases when no review training is offered;
· present types of review and discuss how a review changes by document type/purpose, document review stage, and the reviewer’s functional role;
· provide specific examples of bad review comments and how to improve them;
· provide practical advice on how to best set up review processes (including advice on timelines, reviewers, comments resolution meetings, and electronic tools) and create a long-lasting “review culture” shift;
· provide a “reviewer’s checklist” that regulatory medical writers can use in their future cross-functional trainings on effective review practices.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
16:30
MCF7c
Medical Communication - Foundation
Participant Profile
Anyone who wants to develop their fundamental writing skills by building on the philosophy of writing and the writer’s role in expressing an idea in many ways. Anyone interested in gaining some practical insight into areas of writing (from public relations to regulatory) they may not encounter on a daily basis.Objectives
The primary goal of writing is to convey information to a target audience. This workshop will explore the fundamental concepts of how a writer can express the same story to vastly varied audiences. The workshop and the post-workshop assignment will introduce, actively explore and exercise the different writing styles commonly used in medical writing, emphasising which style is most effective for each audience, and why. Participants will learn and develop one of the fundamental principles of good writing: recognise who you are writing for and write for them.Content
The basic philosophy of considering the purpose of a document will be presented and discussed. Real-life examples (good and bad) and hands-on writing with discussion will demonstrate how to use different writing styles in different contexts, from manuscripts to marketing information.Pre-Workshop Assignment Length: Nonehrs
Post-Workshop Assignment Length: 3:00hrs
Wednesday 12 May
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 ones.Objectives
To increase the likelihood of producing readable research papers with strong purpose statements and well-structured in-depth discussions.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 arguments in the discussion.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:30hrs
to
17:00
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
Thursday 13 May
to
12:45
LWF13+14
Language and Writing - Foundation
Participant Profile
Note this is a double workshop – Part 1 is on Thursday 13 May and Part 2 is on Friday 14 May. You must register for both parts.The workshop is intended for medical writers who edit or proofread their own work or that of their colleagues. It is not intended for people who specialise in medical editing. Previous attendance at another workshop is not required.
Objectives
This workshop aims to give an overview of editing and proofreading. After completing this workshop, participants should be able to:· Appreciate how editing and proofreading contribute to document quality
· Identify and correct substantive and technical errors
· Proofread and clearly show changes that need to be made
· Compile style guides and editing checklists
Content
In this workshop, we will:· Review the need for both editing and proofreading
· Focus on substantive editing: reorganising and editing to ensure that the correct message is delivered effectively and specifications are met
· Discuss how to work effectively with the author
· 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
PTA8
Professional Techniques - Advanced
Participant Profile
Medical writers who wish to understand the analyses of binary data (i.e. yes/no outcomes such as death, response to treatment etc.). Participants should be familiar with basic statistical concepts such as P-values and confidence intervals.Objectives
To gain familiarity with some of the techniques used for analysing binary data and the various measures of association, such as odds ratios or relative risks, used in analysing binary data.Content
The workshop will focus on understanding what the various statistical tests are, why they are done, and how to interpret the results. This will not be a tutorial in how to do the statistical tests (other than some of the simplest ones), as it is assumed that participants will generally receive the results of analyses from statisticians and be given the job of interpreting those results.• Definitions of binary data
• Simple statistical tests to compare binary data in 2 treatment groups: chi-squared test and Fisher’s exact test
• Measures of association of binary variables: odds ratios, risk differences, relative risks
• The Mantel-Haenszel test and other more sophisticated analyses
• Logistic regression: the most powerful technique for analysing binary data
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 3:00hrs
Friday 14 May
to
12:45
LWF13+14
Language and Writing - Foundation
Participant Profile
Note this is a double workshop – Part 1 is on Thursday 13 May and Part 2 is on Friday 14 May. You must register for both parts.The workshop is intended for medical writers who edit or proofread their own work or that of their colleagues. It is not intended for people who specialise in medical editing. Previous attendance at another workshop is not required.
Objectives
This workshop aims to give an overview of editing and proofreading. After completing this workshop, participants should be able to:· Appreciate how editing and proofreading contribute to document quality
· Identify and correct substantive and technical errors
· Proofread and clearly show changes that need to be made
· Compile style guides and editing checklists
Content
In this workshop, we will:· Review the need for both editing and proofreading
· Focus on substantive editing: reorganising and editing to ensure that the correct message is delivered effectively and specifications are met
· Discuss how to work effectively with the author
· 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
PTA2
Professional Techniques - Advanced
Participant Profile
Delegates should include medical writers, particularly those who work within, or for, pharmaceutical companies; project managers (whether by actual title or function); and others with responsibility for overseeing and coordinating multifunctional projects. Participants should have at least 1 year’s experience working within a matrix environment.Objectives
• Acquire understanding of basic project management theory• Apply project management theory to multifunctional projects
• Broaden context beyond medical writing
• Add team-building strategies
Content
Discussion will include project management theory and practical applications, both within the context of a matrix organisation, and as an independent providing services to clients. A medical writing group may also adopt these practices to better control their own destiny.This workshop will be a combination of lecture and in-class exercise, and will include discussions based on analysis of the scenarios presented in the homework. While the majority of the presentation will be didactic, there will be opportunity for attendees to share their experiences and ask questions throughout the presentation.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Saturday 15 May
Participant Profile
This course is intended for medical writers with little or no experience in regulatory writing, including Post-market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports, under the Medical Devices Regulation 2017/745 (EU MDR). There is no prerequisite to attend this workshop but basic knowledge of clinical research and medical device terminologies will be useful.Objectives
With the introduction of the Medical Devices Regulation 2017/745 (EU MDR), each device (or device family) needs a specific PMCF Plan. The results of PMCF activities are summarized in a PMCF Evaluation Report. These documents are subject to predefined review cycles and depend on several other input documents. This course will give you profound insights into the regulatory requirements for PMCF, best practice recommendations on how to prepare PMCF Plans and Reports, and insights into common pitfalls and tips on how to avoid them.Content
The course includes an introduction to:· Annex XIV Part B of EU MDR 2017/745 (Post-Market Clinical Follow-up)
· MDCG (Medical Devices Coordination Group) Guidance on PMCF Plans (2020/7)
· The MDCG (Medical Devices Coordination Group) Guidance on PMCF Evaluation Reports (2020/8)
· Input documents and review cycles
· Different methods to conduct PMCF.
You will work with a fictional medical device to think about general and specific PMCF activities. You will also get insights into what triggers PMCF and how to avoid common pitfalls related to PMCF documentation.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
MCA8
Medical Communication - Advanced
Participant Profile
Anyone who wants to learn more about value messages and writing value dossiers, whether they are new to these topics or have some experience with them. The workshop will not assume any prior knowledge of value dossiers or market access, but will assume a basic familiarity with drug development and clinical data.Objectives
After completing the workshop, you should understand the concept of ‘value’ and be able to construct a value story and value messages for a pharmaceutical product or medical device. You will be familiar with the structure of a typical value dossier and have an understanding of what information is required in each section. You will understand what a value dossier is used for and how to make sure it fulfils users’ needs.Content
Obtaining marketing authorisation is no longer the final step in a drug’s journey to market. Manufacturers must also persuade budget-holders (payers) in each country to pay for it. The global value dossier (also known as core value dossier) is a key resource for pharmaceutical company market access teams. The workshop explain the concept of ‘value’ as it applies to pharmaceutical market access. It will emphasise the importance of the ‘value story’, and participants will learn how to create evidence-based ‘value messages’ (i.e. the claims that are used to show the product’s clinical, humanistic and economic value). The workshop will then describe the structure of a typical value dossier and guide participants through the information that goes into each section, and where to find it. The emphasis throughout will be on ensuring that the document meets the needs of its end-users.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:30hrs
Monday 17 May
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
17:00
MDA2a
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
Tuesday 18 May
Participant Profile
Participants who already mentor other writers or those who may soon be given the role will benefit from this workshop, including those who take on the role voluntarily and those who are more hesitant about their abilities. Most participants will have been medical writing for at least 2-3 years and will have a good foundation in their chosen career path.Complementary workshops: PTA11 – Strategies for Improving Document Quality and PTA12 – Interpersonal Skills for Medical Writers.
Objectives
The aim of this workshop is to give both new and experienced mentors an open and encouraging environment for learning, developing and sharing mentoring skills. The workshop has been devised to inspire and enthuse participants in what is at times a challenging, yet highly rewarding role. After completion of the workshop and class exercises, participants should have a raised awareness of their role as mentors and the impact they may have on their mentees, teams and product quality. The workshop will also discuss strategies to diplomatically manage the varied situations that mentors may encounter.For 2021, we will focus on mentoring virtually.Content
This workshop will cover how mentoring can add significant value to teams and drive improvements in product quality; how to mentor in a holistic manner; how to vary mentoring style according to different mentee personalities; how to allow mentees to develop individually; and how to learn from mentees and develop personally through the mentoring role. Setting up and coordinating mentoring systems is outside the scope of this workshop.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:30hrs
to
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, writing, and submitting DSURs.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
Participant Profile
This workshop is intended for medical writers (and others) who are interested in clinical trials and would like to know more about the evolution of ethical principles associated with human subject participation. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical trial ethics will be provided for interactive discussion.Objectives
To give an overview of the various ethical considerations associated with conducting clinical trials, including institutional oversight, pre-approval access, regulatory authority clearance, subject informed consent, investigatory conflict of interest, issues of fraud, and ensuring subject safety and well-being.Content
This workshop will consist of a combination of presentations on relevant ethical issues, with respect to clinical trials, and group discussions on challenging ethical considerations of some “real-world” case studies. The presentations will focus on the importance of ethics in GCP, the informed consent process, and the challenges that may arise in developing countries. Practical experience will be shared with the participants.Pre-Workshop Assignment Length: 3:00hrs
Post-Workshop Assignment Length: 2:00hrs
Wednesday 19 May
to
12:45
MCF1a
Medical Communication - Foundation
Participant Profile
This workshop is intended for medical writers who have little or no experience in writing peer-reviewed manuscripts. No prior experience in manuscript writing is necessary.Objectives
The goal of the workshop is to give medical writers the confidence to begin writing manuscripts and to improve their chances of getting their manuscripts accepted for publication. After completing the workshop, participants should be familiar with the goals, structure, and content of manuscripts destined for peer-reviewed journals; simple steps to take to avoid immediate rejection and improve the chance of getting a manuscript accepted; the step-by-step process of writing a manuscript; how to select data to include in a manuscript; and how to handle the peer review process both practically and emotionally.Content
This workshop will cover:• Before you start writing a manuscript: choosing a journal
• Instructions and guidelines for manuscripts
• The parts of the manuscript: what belongs where
• Selecting which data to put in a manuscript
• Common pitfalls and how to avoid them
• Step-by-step instructions for writing a manuscript
• The peer review process and how to learn to love it
• The role of the professional medical writer in manuscript writing
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 3:00hrs
to
17:00
MDF3
Medical Devices - Foundation
Participant Profile
This foundation workshop is for those who:· have never written a clinical investigation plan (CIP, synonym clinical study protocol) for medical devices
· are coming from pharma, or
· already have some experience in writing CIPs and want to gain a more profound understanding of this document.
No attendance at a previous workshop is required. However, participants would benefit from having previously attended 'Basics of Writing for Medical Devices under the MEDDEV rev. 4 and new Medical Devices Regulations' (MDF1).
Objectives
The objective of this workshop is to teach participants how to write a CIP for medical devices. Those who have already some experience of writing CIPs will gain a deeper understanding of the background and points to consider.The workshop will focus on CIPs in Europe.
Content
Step-by-step, chapter-by-chapter participants will be taught how to write a CIP for medical devices. Not only will the different content requirements be explained, but also the strategic impact of specific sections. The workshop will also cover tips and tricks on how to gain specific information.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:30hrs
to
18:30
LWA14
Language and Writing - Advanced
Participant Profile
This workshop, at an advanced level, is accessible to all medical writers interested in the journal article and syntactic clarity.Objectives
To enhance understanding the writing distractions pertinent to conceptual components of the journal article. The distractions are focused on syntactic intra-sentence structure and order of words, phrases, and clauses.Content
By the following 3-levels of activities, gain insight into syntactic distractions that are specific for the conceptual components of the medical journal article.(1) Pre-workshop: Complete a clarity-testing exercise. That is, from each of 12+ sets of paired sentences, select the clearer sentence and describe the primary distraction in the unselected sentence. After sending your selections (and justifications) and then receiving a guide to structure and order syntactic distractions, prepare to participate in the workshop.
(2) Workshop: For each set in the clarity-testing exercise, participate in a discussion with other registrants and the workshop facilitator. After the discussion of each set, the workshop facilitator will analyze and justify his decision, after which the vote tally will be revealed and followed by more discussion.
(3) Post-workshop: Comment on the distractions and revisions with which you still disagree.
Pre-Workshop Assignment Length: 2:30hrs
Post-Workshop Assignment Length: 2:30hrs
Thursday 20 May
to
12:45
DDF33+34d
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
· Current guidelines (International Council for Harmonisation [ICH] E3 guidance documents and CORE reference)
· Writing a CSR according to ICH E3
· 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
Medical writers with 0-4 years of experience. No prior knowledge in visual communication is required.Objectives
To learn basic guidelines to achieve appropriate graphical representations of data which retain the main message and improve visual appeal.At the end of the course, participants should be able to:
· Understand some principles of data visualization;
· Identify a main message for each graphical representation;
· Select an appropriate graphical representation for each type of data;
· Improve clarity of the chart or table.
Content
Medical writers need to present data clearly and accurately. Visual representations of data allow to communicate information faster and easier to all audiences. Tables and charts are the most direct data visualization tools, however, if done inappropriately they can mislead the audience and transmit the wrong information.This course will introduce participants to the basic principles of data visualization and discuss the applications and requirements of the most used graphical representations in medical writing – tables and charts. It will cover the choice of a “main message” for each image and formatting issues that may mislead the reader. It will include examples and practical group activities and provide some tips to achieve clear visuals focused on the data.
Although some topics of the workshop may partially overlap those presented in PTF1, this course is more oriented towards fundamentals of design and visualization.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
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
· Biotechnological and therapeutic applications of virology
Pre-Workshop Assignment Length: 0:30hrs
Post-Workshop Assignment Length: 2:00hrs
Friday 21 May
to
12:15
PTF21
Professional Techniques - Foundation
Participant Profile
This workshop is aimed at medical writers who deal with health-related quality of life instruments (HRQoL) in clinical studies or document writing. No prior experience with HRQoL instruments is needed.Objectives
The workshop will give an overview of the different types of HRQoL instruments and the main issues to be considered when using these measures in clinical studies. Participants will learn how to appraise HRQoL measures and acquire a better understanding of HRQoL data.Content
1. What is HRQoL and why measure it?2. Instruments for measuring HRQoL (generic vs. specific, profile vs. preference-based measures)
3. Using HRQoL instruments in a study
- choice of measure
- modes of administration
4. Reporting and interpreting HRQoL data
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:45
DDF33+34d
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
· Current guidelines (International Council for Harmonisation [ICH] E3 guidance documents and CORE reference)
· Writing a CSR according to ICH E3
· 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 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. During the workshop, participants will practice writing and editing abstracts.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:30hrs
Saturday 22 May
to
12:15
PTF18a
Professional Techniques - Foundation
Participant Profile
This workshop is suitable for any medical writer with an interest in writing for the internet, whether already involved in this type of writing or not.Objectives
Medical writers are increasingly asked to provide text for online use. The objective of this workshop is to outline the basic principles of writing for the internet. The emphasis is on understanding how online content differs to more traditional media. We will NOT cover technical aspects such as website design, style sheets, coding, hosting, and related issuesContent
We will review the basic principles of writing for the internet and consider how it differs from writing for print. How readers use the internet and the visual and structural aspects of presenting information online are also covered. We will examine different online writing structures such as the inverted pyramid technique. The importance of headings and sub-headings are also outlined. Other topics such as Search Engine Optimisation (SEO), metadata and calls to action will also be briefly touched upon. The workshop includes practical exercises on creating internet text. A selection of post-workshop assignments will be published on the EMWA website!Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:45
DDA2b
Drug Development - Advanced
Participant Profile
Medical writers with knowledge of MAA or NDA preparation who are interested in expanding their knowledge of authority review processes and the role of medical writing after dossier submission in Europe and the US.Objectives
While the Common Technical Document harmonises the structure of regulatory documents submitted to the European EMA and the US FDA for marketing approval, the review processes leading to the decision on whether to approve or not still differ markedly between the two authorities. In both cases, though, the demand for medical writing skills in the broadest sense (linguistic, scientific, organisational, diplomatic) can be high. The objective of this workshop is to familiarise participants with the post–submission review processes of these two authorities and illustrate the pivotal role medical writers can play in helping to optimise a sponsor’s chances for obtaining a successful drug approval.Content
The workshop will navigate you through the post–submission review processes you can expect to encounter, and through the numerous medical writing activities that can arise during EMA and FDA reviews of a submission dossier (e.g., drafting responses to the authority’s questions, preparing safety updates and NDA amendments, writing briefing documents, organising and preparing presentation materials for CHMP Oral Explanations and FDA Advisory Committee meetings). The workshop illustrates salient points and potential pitfalls by recalling personal experiences working on a European–US approval team. The workshop exercise focuses on how FDA and sponsor can differ in their interpretations of the same data, which will give participants some insight into the FDA Advisory Committee hearing process and into the preparations that need to be made for it by the sponsor.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
16:30
PTF3
Professional Techniques - Foundation
Participant Profile
Medical writers and editors with any level of experience who wish to learn more about the statistics they work with.Objectives
At the end of the course participants should understand the following:· Populations to be analyzed: intent-to-treat, per-protocol, safety-evaluable, worst-case.
· Missing Data and Sensitivity Analyses
· Descriptive statistics: mean, median, mode, range, percentiles, box plot, normal and non-normal distributions, parametric and nonparametric tests, coefficient of variation
· Odds and Hazard Ratios
· Estimates and confidence intervals, and p-values
· Sample size calculations and what they mean
Content
We all write about statistics, but how many of us really have an intuitive feel for what we're writing about? This workshop is designed for participants who have little or no background in statistics. The following statistical concepts will be covered in depth: types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and sample size calculations. Emphasis will be placed on understanding statistical presentations and reporting statistical information, not on calculations or mathematical explanations.Pre-Workshop Assignment Length: 4:00hrs
Post-Workshop Assignment Length: 1:00hrs
Monday 24 May
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 about scientific or medical topics.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
Participant Profile
As professional medical writers should be reporting guideline champions, this workshop is propaedeutic for any workshops on scientific journals or congresses publishing.Objectives
The growing availability of guidelines and checklists makes identification and use of the most appropriate guideline for any specific disclosure more difficult. This workshop will help the writer to identify what is available and understand how to choose and use the most appropriate guidelines for their purpose.Content
The Consolidated Standards of Reporting Trials (CONSORT) statement, issued in 2001, was the first example of a comprehensive and structured guideline on how to communicate the results of randomised clinical trials. In addition, different guidelines and checklists to use for the results of observational, health outcome, quality of life, mixed-method, and many other types of studies have been published. To complement all of these, pharmaceutical companies have developed Good Publication Practice, individual editors have developed their own guidelines, and most journals have their own instructions for authors. In this workshop, we will review the main guidelines to identify when and how they can be used by medical writers to improve the productivity and quality of their job.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Tuesday 25 May
to
12:45
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
12:45
DDA28
Drug Development - Advanced
Participant Profile
The Investigational Medicinal Product Dossier (IMPD) is an important part of the clinical trial application (CTA) which is submitted to the EMA for approval of clinical trials of investigational medicinal products (IMPs) in the EU. Those who stand to benefit from this workshop are regulatory personnel and medical writers in the pharmaceutical industry, CROs, and medical writing agencies who are involved in preparing regulatory documentation – especially documents pertaining to the chemistry, manufacturing, and quality control (CMC) of IMPs.Participants of this workshop will be expected to have experience/knowledge of the drug development and approval process, especially in the US and the EU as well as familiarity with various components of the eCTD.
Objectives
Participants of this workshop will get an overview on the individual parts of the IMPD, as well as details of the relevant source documents and submission requirements and the medical writer’s role in the preparation of the dossier. Additionally, the workshop aims to inform participants on Blockchain technologies, implemented in Supply-Chain-Management, in clinical trials.Content
The IMPD includes summaries of information related to the quality, manufacture and control of the IMP, data from non-clinical studies and from its clinical use. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of the proposed study also have to be part of the IMPD.The main focus of the workshop will be to clarify the medical writer’s role in the selection, assembly, and summary of relevant source documents for drafting a full or simplified IMPD for medicinal drug products, with a strong emphasis on the chemistry, manufacturing, and quality control (CMC) components of these. Furthermore, the workshop aims to educate participants on recent Supply-Chain-Management developments in clinical trials, with focus on Blockchain technologies, required for the IMPD assembly.
The workshop is planned to be interactive and will include discussion of participants’ questions submitted in their pre-workshop assignments, where relevant. There will also be a handful of exercises carried out during the workshop to encourage overall participation.
Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:30hrs
to
17:00
DDA24a
Drug Development - Advanced
Participant Profile
This workshop is intended for medical writers who have already some experience in the writing of clinical study reports (CSRs) but no experience in oncology. Participants should have a general understanding of clinical study designs, of the guidance provided by ICH E3, and should be familiar with statistics, in particular with time-to-event analysis.Objectives
This workshop aims to provide a systematic overview of what is different about oncology CSRs. Having attended the workshop, Medical Writers should have an understanding of key oncology concepts and should be able to apply these to the writing of the different report sections.Content
The workshop will introduce key oncology concepts and will outline how these concepts inform the writing of the CSR. We will go through the report sections (following ICH E3). Topics discussed along the way will include:· Patients with cancer: diagnosis, treatment modalities, disease progression
· Clinical studies in oncology: study design; interim vs. final analysis; trial committees (Data Monitoring Committee, Central Independent Review)
· Drugs in oncology: principles of dose finding, treatment schedules, dose reduction / escalation, management of side effects
· Efficacy: assessment of tumour response – RECIST; central independent review vs. investigator assessment of tumour imaging; time-dependent endpoints, especially progression-free survival, time to progression, overall survival; importance of censoring rules
· Safety: CTCAE grading system, Dose Limiting Toxicities and Maximum Tolerated Dose, MedDRA and Standard MedDRA Query, the concept of "adverse events of special interest"
Pre-Workshop Assignment Length: 2:30hrs
Post-Workshop Assignment Length: 3:00hrs