53rd EMWA Conference - Berlin

3-7 May 2022

Note that after the conference in Berlin, a short programme of VIRTUAL workshops will run between 12 and 16 May. The details of these virtual workshops are included in the list below.

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

EPDP workshops

If you attend an EPDP workshop and successfully complete the pre- and post-workshop assignments you can gain an EPDP credit (2 for a double workshop), which can allow you to apply for an EMWA certificate of professional development. See the EPDP brochure for details. However, you are welcome to attend workshops without doing them for credit. 

If you are intending to do the workshop for credit, please note that to gain a credit you must:

  • Attend the workshop. Participants who miss more than 30 minutes of instructional time (by arriving late, leaving early or by being absent from the session for a long period) will not be eligible for credit, and
  • Satisfactorily complete the pre-workshop assignment (if applicable), and
  • Satisfactorily complete the post-workshop assignment, and submit it by the deadline given.

For more information about gaining credits, see the Training page on the EMWA website and the link there to the EPDP brochure.

We suggest you consider the workload associated with the workshops you are considering booking. Past conference delegates have told us that attending 4 workshops can result in a post-conference workload that is hard to fit in with work and other commitments.

Post-workshop assignments typically take up to 3 hours to complete (see the workshop abstracts for more detail) and the deadline is usually 6 weeks after the conference.  Post-workshop assignments must be your own work. We do not accept joint submissions or submissions based on joint working unless specified by the workshop leader.

When you have registered for a workshop, download the pre-workshop assignment using the link on the right hand side of the workshop listing. You do not need to wait for further instructions from the workshop leader. If a pre-workshop assignment is not showing after 25 March please contact info@emwa.org for further information. 

IMPORTANT: if you are aiming to gain an EPDP credit for a workshop, READ THE INFORMATION in the email we will send confirming your registration. This will include the rules on how to gain credits, which can allow you to apply for an EMWA certificate of professional development. It is your responsibility to read this information and adhere to any deadlines for submitting workshop assignments.

 

 

 

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Wednesday 4 May

08:45
to
11:45

Introduction to Medical Writing
Seminar - Not for credit

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.
08:45
to
11:45

PTF3
Using Statistics in Medical Writing
Professional Techniques - Foundation

Participant Profile

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

Objectives

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

Content

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

Pre-Workshop Assignment Length: 4:00hrs

Post-Workshop Assignment Length: 1:00hrs

08:45
to
12:15

MCA4
Manuscript Writing: from Good to Excellent
Medical Communication - Advanced

Participant Profile

Participants should have some experience with writing scientific papers. The workshop is relevant for those who write or edit papers for others, and for those who wish to improve their own papers.

Objectives

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

Content

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

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
12:15

PTA15

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 can
1) integrate during lead writer coordination of review cycles and 2) use to establish and improve review practices with their clinical teams or organisations. Participants will learn how to better clarify review expectations and systematically train reviewers to ensure a smooth collaboration, whether working on individual documents or establishing and improving organisation-level processes.

Content

This will be a highly interactive workshop with a lot of practical advice, discussion and group exercises. This workshop will:
· provide practical advice on how to coordinate review cycles by training reviewers;
· identify common problem areas in the review of regulatory documents;
· define review, highlighting features of an effective review for developing fit-for-purpose documents, in contrast to cases when no review training is offered;
· present types of review and discuss how a review changes by document type/purpose, document review stage, and the reviewer’s functional role;
· provide specific examples of bad review comments and how to improve them;
· provide practical advice on how to best set up review processes (including advice on timelines, reviewers, comments resolution meetings, and electronic tools) and create a long-lasting “review culture” shift;
· provide a “reviewer’s checklist” that regulatory medical writers can use in their future cross-functional trainings on effective review practices.

Pre-Workshop Assignment Length: 1:15hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

DDA31
Orphan Medicinal Drug Products
Drug Development - Advanced

Participant Profile

This workshop will benefit medical writers who have an interest in the clinical development of orphan medicinal products, and who are familiar with the European Medicines Agency marketing authorisation application (MAA) procedures. Prior attendance to DDF13 Basic Concepts of Study Design in Clinical Development would be helpful but is not essential.

Objectives

To provide participants with an understanding of how to prepare the scientific part of an orphan designation application and to recognise strategies used in clinical development of an orphan medicinal product.

Content

Orphan medicinal products are intended to treat rare diseases, and the pharmaceutical industry are eligible for a number of incentives if they develop these products. However, a medicinal product cannot be granted orphan designation unless orphan designation is approved by the European Commission, and an approval of orphan designation is not a guarantee for a successful marketing authorisation. Clinical development of orphan medicinal products is often complex because rare diseases are poorly characterised and under-researched at the time of development, and only affect a small percentage of the population. This workshop will provide an overview of orphan medicinal products, rare diseases and incentives; provide an overview of the orphan designation procedure; provide guidance on how to prepare a comprehensive orphan designation application (scientific part); and provide strategies for clinical development in orphan medicinal products. As protocol assistance is an incentive granted for orphan designation, an overview of the procedure will also be covered.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

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 anonymisation report, 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

08:45
to
12:15

DDA18a
Medical Writing for Healthy Volunteer Studies
Drug Development - Advanced

Participant Profile

This workshop is for medical writers who would like to learn more about writing the documents needed for clinical trials conducted with healthy volunteers rather than patients (such as Phase 1, thorough QT, and bioequivalence studies). Participants should have basic knowledge of healthy volunteer study objectives and design (participants who do not have this knowledge should first take Workshop DDF39 An Overview of Healthy Volunteer Studies) and some experience in writing key clinical trial documents (informed consent forms, protocols, clinical study reports).

Objectives

Healthy volunteer studies make up a large proportion of studies in most clinical development programmes. Medical writers need to understand how these studies differ from clinical trials in patients and how the differences affect the documents required for these studies. After attending this workshop, the participant will understand the unique structural and content requirements of documents related to healthy volunteer studies.

Content

This workshop will cover the following topics for healthy volunteer studies:
• Key regulatory guidance documents
• Protocols
• Informed consent forms
• Clinical study reports
Note: Phase I studies in patients will not be covered.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

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

13:30
to
17:00

DDA24b
Clinical Study Reports in Oncology
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 basic clinical trial statistics.

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

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

13:30
to
17:00

DDA33

Participant Profile

The workshop is for MWs working in the CRO or pharma environment, who have written at least one or reviewed several clinical study protocols (CSPs). Managers of MW groups will also benefit from understanding estimand-driven processes that impact business and wider operational considerations.

Objectives

The workshop is designed to facilitate interpretation of the International Council for Harmonisation (ICH) guideline E9(R1) 2019, which drives estimand development into trial design, and to clarify the MW’s role and responsibilities in relation to that of medical experts and statisticians in ensuring that estimands are considered as part of a proactive cross-functional approach to writing the CSP. At the end of the workshop, attendees should understand the concept of estimands and their impact on CSPs and other study-level documents, and have acquired the knowledge and skills to author or review CSPs that include estimands.

Content

Inclusion of estimands into confirmatory clinical trials is mandated through ICH guidance E9(R1) 2019, which is targeted at statisticians but also needs to be understood by MWs who often lead on CSP design and development. A general process will be described to enable MWs to develop and describe estimands at a level appropriate for the CSP. Open access resources will be demonstrated and some illustrative examples will be presented to clarify statistical concepts associated with estimands. To enhance learning, attendees will work on examples provided during the workshop. Detailed statistical analysis methods will not be covered in the workshop.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

PTF42
Essentials of Data Visualisation
Professional Techniques - Foundation

Participant Profile

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

Objectives

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

Content

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

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

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

13:30
to
17:00

MCF21
Promotional Medical Writing: the Dark Side
Medical Communication - Foundation

Participant Profile

• Medical writers that have worked primarily on the regulatory side with a desire to
expand into promotional medical writing
• Medical writers starting out in a healthcare communications and/or advertising
agency

Objectives

Hundreds of thousands of words and pages are dedicated to the process of getting
pharmaceutical products tested, approved and in the hands of doctors. Near the end of
this process, you will find marketers. The people who are working to get these products
prescribed for patients. Participants in this workshop will gain understanding about what
goes on behind the scenes in pharmaceutical marketing and the role of the medical
writer, learn about the wide variety of materials produced at this stage, and be equipped
to communicate appropriate effective, consistent selling messages across media.

Content

The objective of the workshop will be achieved by providing participants with an
overview of medical communications and where marketing and promotion fits into the
bigger picture, going through the basic structure of agencies that work in this field and
the role of the medical writer, covering the profile of clients and the end audience,
clarifying the difference between pre- and post-launch materials, detailing the types of
materials to be created and the regulations that guide pharmaceutical promotions. We
will also get into the creative side of things by learning how to craft effective messages
that fit into the limitations of what can and cannot be said based on science, ethics and
available data. We will conclude by summarising the keys to becoming a successful
medical writer in the field of promotional marketing.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

Thursday 5 May

08:45
to
11:45

DDF53

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

08:45
to
12:15

MSA1
Advanced Epidemiology
Medical Science - Advanced

Participant Profile

Experienced writers with basic knowledge of incidence, prevalence, relative measures of association and descriptive statistics. Participants are recommended to take the “Basics of Epidemiology for Medical Communicators” workshop before enrolling in this advanced workshop.

Objectives

The underlying principle of this workshop is that medical communicators have a key gatekeeper’s role in ensuring accurate writing and interpretation of medical findings. Participants will be provided with data interpretation insights according to epidemiological concepts. Focus is on the "critical" appraisal of reported medical findings and the application of epidemiological tenets to improve their writing. Common research designs, relative measures of association, and causality development will be discussed using recent examples from clinical medicine, public health and pharmacoepidemiology. Selected reporting guidelines are explained as useful tools to support critical writing. Class format will combine lectures with interactive group exercises and fun quizzes. No calculations, tabulations or graphing are required for this workshop.

Main objectives are:
• to provide data interpretation insights based on "critical" epidemiological principles
• to encourage the use of reporting guidelines and checklists (including STROBE, CONSORT)

Content

Major topics
· brief overview of common research designs - strengths and limitations
· association and causation - making sense of a confounding couple
· use of reporting guidelines to enhance medical writing and interpretation

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 1:00hrs

Participant Profile

This workshop was previously run under the title 'Patient Registries as a Source of Medical Information’.

This workshop addresses medical writers who prepare publications based on the data from research databases, patient registries and other real-life data sources. Basic knowledge of the design of observational studies, epidemiological research and statistics is not critical, but would be beneficial.

Objectives

To present the pros and cons of real-life research, to teach how to avoid over-interpretation of the study results, and to present these data effectively. Finally, to position patient registries as a complement to experimental studies.

Content

Nowadays, real-life medical data sources such as research databases or patient registries are gaining in importance as a source of medical information, and medical writers are often involved in preparing manuscripts based on these data. However, it should be highlighted that the way these data are reported differs from the way the data from experimental trials are presented. This workshop focuses on the basic concepts of real-life medical research, the differences between the data from real-life settings and experimental trials, the ways of publishing them, and the issues medical writer must think of while writing such papers. Furthermore, it will present the overview of the main aspects of analysis and interpretation of the registry data, including specific statistical problems (but without going into mathematical details). The workshop will include examples of registries and relevant papers to illustrate the potential of this kind of research.

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

MDF4

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

Friday 6 May

08:45
to
11:45

PTF29
How to Manage Your Writing Project
Professional Techniques - Foundation

Participant Profile

This workshop is aimed at writers with limited experience of managing projects and those who need help in ensuring their deliverables meet client expectations and are delivered on time and on budget. The workshop does not cover project management of more complex multifunctional projects. These are covered in the Advanced Workshop “Do More with Less Faster: Project Management for Biomedical Communications”. Other related workshops include “Time Management for Medical Writers”.

Objectives

Apart from writing skills, project management skills are one of the most important skills needed to ensure timely delivery of a quality document. A good writer should take overall ownership of their document during development and drive the writing process forward, ensuring deadlines are met. There are no prerequisites for attendance.
Participants will learn how to plan timelines, determine and confirm roles and responsibilities, arrange effective meetings, communicate effectively and generally ensure that they know exactly what they need to provide, in what format and when.

Content

This workshop covers the basics of managing a writing project. It deals with client expectations, project scope, timelines and costings, planning and management as well as how to identify problems and possible solutions and how to deal with unrealistic requests and timelines. We will look at 3 tools to help with managing projects (effective communication, robust dialogue and effective meetings) and exercises will be included to get delegates to think about creative solutions to problems, how to use robust dialogue techniques and how to ensure you have the information to deliver what is wanted.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

Participant Profile

This workshop is intended for medical writers with little or no experience in regulatory writing under the Medical Devices Regulation 2017/745 (EU MDR) who would like to learn how to prepare a compliant Clinical Evaluation Plan. There is no prerequisite to attend this workshop, but basic knowledge of clinical research methodology and medical device terminologies will be useful.

Objectives

The Clinical Evaluation Plan (CEP) is a key document that provides the foundation on which the clinical evaluation of a medical device is based. The objective of this workshop is to introduce participants to the regulatory requirements for this document and provide them with an understanding of how a well-written CEP can streamline the clinical evaluation process.

Content

The workshop will provide a detailed overview of the contents of the CEP required under EU MDR. Specific topics covered include determining the clinical evaluation strategy best suited to your medical device, special considerations for legacy devices and new development, identifying appropriate safety and performance measures, identifying suitable equivalent or benchmark devices, the Clinical Development Plan, and an initial assessment of PMCF needs. The workshop will include group exercises and examples for low, medium, and high-risk class devices.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

LWA4
Beyond Simple Editing
Language and Writing - Advanced

Participant Profile

Experienced medical writers or editors who are ready to move into a more senior role. Participants should be competent in editing for style and formatting and in basic language editing.

Objectives

To consider the elements of in-depth editing – that is, editing that involves revising a piece of text to maximise its effectiveness.

Content

We will briefly review the elements of editing and then consider how in-depth editing can improve the quality of a document. Participants will carefully examine a piece of text using questions raised as part of the pre-workshop assignment. We will then discuss how the text could be revised, and what should be prioritised if working to a deadline. Exercises will focus on parts of the document and participants will complete the revisions as part of the post-workshop assignment. The workshop will be interactive, with time for the participants to share their experience. The focus of the workshop is on decision making and not on tools to support editing, although those may come up in our group discussions.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

MCA28
Publication Planning
Medical Communication - Advanced

Participant Profile

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

Objectives

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

Content

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

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

DDF35
Introduction to Writing about Efficacy
Drug Development - Foundation

Participant Profile

This workshop is aimed at medical writers with little or no experience of writing about efficacy in clinical and regulatory documents. Basic knowledge of the clinical development process is expected.

Objectives

The workshop aims to give participants a basic understanding of the general principles by which efficacy is evaluated in clinical trials. Participants will gain a broad awareness of the different kinds of efficacy endpoints and statistical analyses they are likely to encounter. The focus is not on detailed statistical theory, but on practical approaches to understanding efficacy analyses and reporting their results in a clinical study report, regardless of clinical indication. The workshop includes exercises designed to give participants hands-on practice at using statistical analysis plans to understand and describe efficacy analyses, and at interpreting data tables for efficacy. After completing the workshop, participants should be better equipped to write the efficacy sections of clinical documents.

Content

The workshop will cover: Introduction to efficacy • How is efficacy evaluated? • Estimating treatment effects • Hypotheses and statistical tests • Using statistical analysis plans • Understanding statistical output for efficacy • Efficacy in clinical study reports

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
12:15

MCF18
Abstracts
Medical Communication - Foundation

Participant Profile

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

Objectives

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

Content

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

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:00hrs

Participant Profile

This workshop is intended for participants wishing to learn about the requirements, timings, and processes for disclosure of clinical trial results in public databases in the US (ClinicalTrials.gov) and EU (EudraCT). Understanding basic clinical development stages and knowledge of regulatory documents (clinical study protocol, clinical study report, and statistical analysis plan) are essential. Previous experience in clinical trial results disclosure is not required.

Objectives

Upon completion participants will:
· understand requirements for disclosure of trial results in the US and EU
· be familiar with the content of US and EU trial results records
· be able to enter data directly into ClinicalTrials.gov and EudraCT
· recognise similarities and differences between the databases
· realise the relevance of careful planning for public disclosure activities
· appreciate the importance of content consistency across clinical trial documents in the public domain

Content

The workshop will contain the following:
i) brief Q&A session on legal regulations and non-legal requirements governing results disclosure for the US and EU
ii) summary of the requirements and content of the US and EU clinical trial results records
iii) brief introduction to the new Clinical Trials Information System (CTIS)
iv) practical tips on how to approach authoring of the results entries
v) live presentation of the database structure and study results entry
vi) considerations and implications for medical writers preparing results records, with practical examples

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
16:30

PTA17
Graphical Abstracts
Professional Techniques - Advanced

Participant Profile

Graphical abstracts are a unique way to communicate scientific information visually. Often such visualisations are requested by journals to be submitted as publication extenders. Those who stand to benefit from this workshop are medical writers & communicators in the pharmaceutical industry, CROs, medical writing agencies, and academic institutions who are involved in the preparation of scientific publications.

Participants of this workshop will be expected to have a basic understanding of Microsoft PowerPoint. Ideally you
bring your own laptop with pre-installed Microsoft PowerPoint 365®.

Objectives

The intention of this workshop is to educate medical writers & communicators on the concept of graphical abstracts using Microsoft PowerPoint 365®.

Content

The Graphical Abstract workshop will provide an overview of key elements of graphical abstracts, how to create graphical abstracts using Microsoft PowerPoint 365®, and what the current requirements for graphical abstract submission and publication are.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
16:30

PTF13
Critical Appraisal of Medical Literature
Professional Techniques - Foundation

Participant Profile

This workshop will be of use to all medical writers who need to read published medical papers and interpret their findings. Participants should have a basic grasp of trial design (parallel groups, crossovers, etc.) and recognition of (but not necessarily practical experience of using) common statistical tests (e.g. chi-squared, t-test).

Objectives

After attending this workshop, participants should be able to assess the strengths and weaknesses of papers they read in the medical literature and be able to judge whether the published conclusions of the paper are valid.

Content

The workshop will explain what to look for when reading published papers, with emphasis on assessing strengths and weaknesses of the research described. This will include considerations of study design, sources of potential bias, use of appropriate statistical methods, choice of endpoints, and generalisability. The workshop will include practical exercises in critiquing papers in a group discussion format.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

DDF17b
Ethical Issues in Health Care
Drug Development - Foundation

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, 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 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

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 (536/2014). Participants should understand the structure of clinical study reports (ICH E3) and should know the basics of clinical research (trial design, efficacy and safety analysis, basic statistics). Previous experience in writing documents (such as Informed Consent Forms) for study participants or the public is helpful.

Objectives

Writing lay summaries is difficult and challenging. Medical writers need to know and apply plain language writing principles. However, the provision of lay summaries comprises many other activities and skills. The workshop will introduce the many different aspects of providing lay summaries: knowledge on the available regulatory guidance, the positions of the various stake holders (pharma and patient organisations), the challenges of the actual writing of lay summaries, and the necessary considerations for appropriate translation and 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, Good Lay Summary Practice Initiative [EudraLex 10]) will be introduced and briefly discussed. The content requirements for lay summaries will be presented and possible approaches will be discussed. However, only the basic principles of plain language writing will be covered. Participants will be asked to write a short paragraph of a lay summary based on a clinical document. In addition, methods for patient involvement in writing and review of lay summaries will be highlighted. Furthermore, translation of lay summaries and the various distribution options will be presented and discussed.

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

MDA2
Writing Clinical Evaluation Reports
Medical Devices - Advanced

Participant Profile

Medical writers with experience in regulatory writing for medicinal products or medical devices. Participants should have attended the workshop ‘Introduction to Writing for Medical Devices’ or should have a basic knowledge of the market approval process for medical devices.

Objectives

To provide guidance and insight into the clinical evaluation process and report writing for medium- and high-risk medical devices.

Content

Main elements of the workshop are:
• A brief overview of the market approval process and the role of the clinical evaluation
• The Clinical Evaluation Plan
• The Clinical Evaluation Report (CER): content and data/documents to be used for its preparation
o Pre-clinical and clinical data
o Risk management documents
o Post-market surveillance documents
o Claims
o Device information provided by the manufacturer to the user
o State-of–the-Art analysis
o Benefit/risk assessment

The workshop will include group exercises and discussions as well as evaluations of anonymised documents.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

Saturday 7 May

08:45
to
11:45

PTF19
An Introduction to Marketing for Medical Writers
Professional Techniques - Foundation

Participant Profile

Anyone who wants to gain a better understanding of the basic concepts and theories of marketing.

Objectives

Participants will gain insights into how pervasive and persuasive marketing is, and how attention to detail can help them to improve both their own and their firm’s image. By demystifying marketing, workshop participants can both identify and implement simple techniques in many elements of their daily work. Participants will have to bring their own marketing examples to the workshop for discussion. This thought-provoking workshop will lead you to view the process of marketing in a new light. (Please note that the main workshop focus is on general marketing theories and real-life examples drawn from different industries).

Content

Topics covered include the marketing concept, the marketing mix, buyer behaviour, the promotional mix, and strategic analysis. The workshop includes a mixture of lecturing, real-life examples, group activities and discussion.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

MSF10a
An Introduction to Vaccines
Medical Science - Foundation

Participant Profile

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

Objectives

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

Content

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

Pre-Workshop Assignment Length: 0:20hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

MSF7
Fundamentals of Immunology
Medical Science - Foundation

Participant Profile

This workshop is intended for medical writers with little or no background in immunology or those who are interested in refreshing their knowledge on the basic principles of immunology

Objectives

The purpose of this workshop is to introduce medical writers (irrespective of their area of specialisation or the nature of documents they work on) to the basic principles of immunology. The ultimate aim of the workshop is to enable medical writers to better understand fundamental immunological concepts which in turn helps to better interpret the meaning of the results of clinical trials.

Content

The workshop will cover the following aspects: structure and functioning of the immune system, types of immunity and interactions, and immune system related disorders.

Based on the preworkshop assignment, two different group activities will take place to co-create a glossary of specific terminology/concepts in immunology.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

MDF3

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

08:45
to
12:15

MSF13

Participant Profile

Any regulatory medical writer looking to understand the basics of cell signalling and how it can be used for modern drug development.
Ideally, participants will have taken workshops MSF9 (The Fundamentals of Genetics for Medical Writers) and MSF1 (Pharmacology for Medical Writers: the Basics) or have an equivalent knowledge, but the basic concepts required are included in the pre-workshop assignment as a reminder.

Objectives

As medical writers, some knowledge of molecular biology (including cell signalling) is important in order to understand the molecular mechanism of action of a drug, which is the fundament for many clinical development programs.
The aim of this workshop is to introduce basic concepts of signal transduction, how this knowledge can be used to develop new drugs, and how details about cellular signalling are described in regulatory documents and manuscripts.

Content

The basic theoretical concepts of cellular signalling will be introduced (forms of signalling, common signalling molecules, components of signalling cascades, etc). How the knowledge of these basic concepts can help drug development will be discussed. The molecular mechanism of action of several marketed drugs will be introduced and compared to the descriptions found in relevant regulatory documents (examples from the EMA database) and manuscripts.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 1:30hrs

Thursday 12 May

Participant Profile

This workshop is intended for participants wishing to learn about the requirements, the content and structure, input documents, and review cycles of the Summary of Safety and Clinical Performance (SSCP) for medical device. Basic knowledge of the Medical Devices Regulation 2017/745 is required.

Objectives

The Medical Devices Regulation 2017/745 (EU MDR) introduced a new document – the Summary of Safety and Clinical Performance (SSCP) – to provide access to safety and performance data to the public. Medical writers are essential to support manufacturers in writing structured and clear SSCPs for both healthcare professionals and lay persons. The SSCP requires input from several parts of the technical documentation and is subject to predefined review cycles. This workshop will give you profound insights into the regulatory requirements for the SSPCs, best practice recommendations on how to draft your first SSCPs, as well as tips and tricks on writing for a lay audience.

Content

The course includes the following topics:
- Regulatory framework: Article 32 of the EU MDR 2017/745
- Structure and Content - The MDCG (Medical Devices Coordination Group) Guidance on SSCPs (2019-9)
- Input documents and review cycles
- How to summarize safety and performance data for the SSCP
- Differences between the healthcare professional and lay person section
The workshop will include exercises, group discussions, and best practice tips.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:30hrs

Participant Profile

This workshop is intended for writers who have basic experience in regulatory medical writing (RMW) and an interest in document consistency and project management. Writers without previous RMW experience could also benefit from this workshop after completing one additional pre‑workshop requirement.

Objectives

This workshop aims to demonstrate what consistency is, how writers can recognize and avoid inconsistencies, and provide tips for project management in large-team submission projects. Following this workshop, participants should be able to recognize the different types of consistency, identify inconsistencies and avoid/correct them, and manage demanding submission projects (including timelines) with more confidence and competence.

Content

The workshop will give good and bad examples of document consistency and demonstrate how writers can recognize and avoid/correct inconsistencies; present advice for improving inter‑ and intra‑document consistency; use examples from submission projects to explain strategies for consistent complex documents; provide project management tips to help face the challenges of working in large teams of writers and reviewers; provide tips for better team communication and timelines management.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:30hrs

Friday 13 May

09:15
to
12:45

DDF38a

Participant Profile

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

Objectives

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

Content

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

Pre-Workshop Assignment Length: 3:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

MCF1a
Introduction to Manuscript Writing VIRTUAL WORKSHOP
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

Saturday 14 May

16:00
to
19:30

LWA12
Master Class: Taxonomic Analysis of Medical Writing
Language and Writing - Advanced

Participant Profile

Experienced medical writers.

Objectives

To enhance the identification, analysis, and revision of syntactic writing distractions.

Content

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

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

Monday 16 May

13:30
to
17:00

MDA1

Participant Profile

This workshop is intended for medical writers who are either interested in working with medical devices or who already work with medical devices and are involved in preparing literature reviews for clinical evaluation reports (CERs). Familiarity with European medical device regulations and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. 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 how to write a literature review as part of a CER. Participants will learn how to prepare a literature review to Medical Device Regulation (MDR) requirements.

Content

The workshop will explain the following:
· the role of the literature review in the clinical evaluation of a medical device;
· the scope of the literature review;
· developing literature search strategies for the subject device and state of the art (current knowledge);
· writing the state of the art section;
· screening and appraising the literature for the subject device;
· data extraction;
· analysing and presenting the literature in the CER;
· literature disposition;
· citing references and listing excluded references.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs