57th EMWA Conference - Valencia, Spain
7-11 May 2024
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 one of more workshops 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 to book. Past conference delegates have told us that attending more than 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 here. 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 membership@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.
The EMWA Professional Development Committee are excited to announce that four Expert Discussion Groups (EDG), initially introduced at the conference in Prague, will again be offered this spring in Valencia. The EDG sessions are led by experts and are tailored to experienced EMWA members
The discussion groups will be led by an expert moderator who will choose the subject and 2–3 relevant questions to guide discussion. They will also recommend the level of understanding or experience of the topic that attendees should have to ensure that they are able to fully contribute to, and benefit from, the discussion. In the EDG description you will find the questions that have been posed and the experience questions. The group number will be set by the moderator but will be in the range of 8–10 attendees so everyone has a chance to contribute. The topics that have been chosen are relevant, timely and thought-provoking. We are expecting lively and informed discussions.
Many of our expert members are no longer seeking credit for EMWA certification, and as the EDGs take the form of a discussion rather than formal taught content, attendance at or moderation of the DGs will not be eligible for credit.
Wednesday 8 May
to
11:45
MSF9
Medical Science - Foundation
Participant Profile
This workshop will give a basic understanding of genetic principles to any writer who may need to understand or write about pharmacogenetics or genomics, or with an interest or curiosity in the field. It will also be useful revision for anyone who has not been involved in the area for some time. No prior knowledge is necessary. Participants may find this a useful preparatory workshop for MSF4, Pharmacogenomics, at future conferences.Objectives
An understanding of genetics is becoming increasingly important in the pharmaceutical industry as the sciences of pharmacogenetics and pharmacogenomics grow and influence most aspects of drug research and development. As professional communicators, it is vital that medical writers have a basic understanding of genetics to be able to communicate the latest research and its effects correctly and effectively to regulators, healthcare professionals and even patients. Unfortunately, this area of science is often explained poorly or confusingly, and academic research papers assume a certain level of genetics knowledge. This workshop is intended to give a grounding in genetics, to explain basic genetic terminology and nomenclature, and to introduce writers to genetic research. The aim is that participants will be equipped to both cope with more advanced workshops involving pharmacogenomics, and to understand and interpret genetics research more easily.Content
Participants will be led through the basics of inheritance, from the behaviour of DNA in cell division, through to inheritance patterns and how these may be predicted. Advances in sequencing and advanced topics such as pharmacogenomics, medical genetics, and epigenetics will be mentioned but detailed descriptions are beyond the scope of this workshop. The correct nomenclature and syntax will be explained (e.g. how to differentiate between genotype and phenotype).Pre-Workshop Assignment Length: 0:30hrs
Post-Workshop Assignment Length: 2:00hrs
Participant Profile
This workshop is aimed at experienced writers who are interested in or work in publication planning. It is particularly useful for writers who are expected to recommend journals for publications, and congresses for presentations or are involved in the development of scientific communication plans. Participants should know the basics of effective and ethical scientific communication.Objectives
The workshop objective is to convey concepts of strategic communication and publication planning in a unified approach on which to base the development and tracking of a publication plan.Content
Publication plans incorporate details of clinical trial programs and make recommendations on publications – e.g. publication types, journals, meetings, and timing to maximize publication opportunity.The introductory part will refresh the concept of effective communication and the environment of publications. The workshop will cover issues to consider during the development of a data-driven plan; e.g. the influence of data availability, journal and meeting choice, and milestone dates. The most relevant aspects of an effective communication strategy and its implementation will be actively discussed.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
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 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 immunologyObjectives
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
Participant Profile
This workshop is targeted towards medical writers whose native language is not English. Native speakers who encounter difficulties with the use of tense or who need to be aware of the difficulties experienced by non-native English writers in this area are also welcome.Objectives
Provide guidance for medical writers who are not native speakers of English on the effective use of tense in English scientific and medical texts.Content
The use of tense in English is a major problem area for medical writers whose first language is not English. This workshop will focus on the proper use of tense as a key element in meaning in our types of text. Examples of typical problems are distinguishing between the simple past and present perfect, choosing the right tense for generally valid statements, correctly applying different forms of present and future tenses, and the appropriate use of modal verbs. Based on the presentations and hands-on exercises, we will look at the different tenses used in different sections of study protocols, study reports and other documents typically prepared by medical writers. More exercises will show us how some tenses are more suitable when speaking and some more suitable when writing.For the pre-workshop assignment, participants will be required to submit particular problems with tense they encounter when working with medical documents in English. The workshop leaders will analyse and discuss selected topics from the participants’ pre-workshop assignments during the workshop. Exercises based on these examples will give participants the opportunity to discuss solutions amongst themselves and with the workshop leaders. The post-workshop assignment will consolidate the content of the workshop.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 3:00hrs
to
12:15
LWF21a
Language and Writing - Foundation
Participant Profile
This workshop is for both native and non-native speakers of English who would like to write more clearly in English. Participants should have some experience of writing 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 clear, concise English. This workshop will provide specific writing tools and techniques that writers can use 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 a strong sentence in English and specific techniques to self-correct their writing. The second part of the workshop will show how these language elements can be used to tell a story using concise and clearly constructed paragraphs and sections. Using guidelines and templates to facilitate story structures will also be discussed. Participants will be encouraged to participate actively in the workshop and will have the opportunity to practice the techniques learned.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: hrs
to
12:15
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
12:15
PTF42
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 and purpose; 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. We will introduce participants to the basic principles of design and fundamentals of visualisation and 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, as well as specific tips to achieve clear visuals focused on the data.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
DDF33+34b
Drug Development - Foundation
Participant Profile
This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).Objectives
The objective of this workshop is to equip you with the essential skills required for the management and preparation of high quality CSRs. This includes in-depth sessions on both the writing of CSRs as well as their project management. The workshop will include group exercises and discussions so that participants can develop new skills attained and learn from each other’s experiences.This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the production of CSRs.
Content
The course will cover:• CSR project preparation and timelines
• Writing a CSR according to International Conference on Harmonisation (ICH) E3 guidelines and CORE reference
• Writing the methods sections: brief overview and advice
• Interpreting data, describing results: demography and baseline characteristics
• Interpreting data, describing results: efficacy; using the statistical report
• Interpreting data, describing results: safety and safety narratives
• Different types of CSRs: abbreviated CSR, full CSR, post-marketing reports, medical device reports
• CSR review and quality control
• Appendices: an overview
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
10:30
Expert Discussion Group - Not for credit
Content
In recent years, great strides have been made within paediatric drug development. In part, this has been due to the introduction of the EU Paediatric Regulations and the implementation of mandatory Paediatric Investigation Plan (PIP) submission and agreement. Clinical drug developers are now faced with integration of studies in children in their overall development program and route to marketing authorisation. The Discussion Group aims to facilitate discussion of the benefits and challenges of working on PIPs, as well as sharing any experiences to date within the group. Topics to be covered will include how the challenges and solutions to writing a successful PIP, indication-specific complexities that arise during writing, and useful tips and tricks.to
15:00
Expert Discussion Group
Content
Whether for regulatory or medical communication purposes, the challenges of writing for Rare Diseases offer a completely different writing experience. Rare diseases are, by definition, individually rare, often with a limited understanding of the condition and less investment into research compared to more common disorders.Many rare diseases have long diagnostic delays and few treatments available. Equally, there is a greater healthcare inequity across the globe for rare diseases due to infrastructure and financial constraints. The patient advocate voice is very loud in this community as families fight for improvements in care, funding and research. Thus, their voice is imperative to progress. As medical writers, we are the gatekeepers for progress in rare diseases, raising awareness, providing patient educational materials, and ensuring the patient advocacy voice is heard in every aspect of clinical trials.
Medical writing for rare diseases is more patient-centric than other forms of medical writing, simply because often, the patients know more about their conditions than the healthcare professionals.
to
16:30
DDF32b
Drug Development - Foundation
Participant Profile
Writers who want to better understand the different types of pharmacovigilance (PV) documents, when and why they are needed and how they interact with each other. It is recommended that this workshop is completed before attending the advanced workshops for writing Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and Periodic Benefit-Risk Evaluation Reports (PBRER).Objectives
After completing this workshop, participants will have basic understanding of the different PV documents required by the regulatory authorities both prior to marketing and post-marketing. They will understand the purpose of the documents, when they are required, how they interact and overlap with each other and what guidance is available to help in preparation of them. In addition, they will be introduced to the difference of the safety data collected in clinical trials and post-marketing.Content
In depth document content and format is covered in other document-specific workshops. This workshop will provide a basic overview of RMP, DSUR and PBRER, and explain the standard terms and definitions routinely used in PV documents. It will discuss overlaps and links between these documents, available guidance, when and why the documents are needed, who uses them, and what the roles medical writers in clinical development and PV have in developing the documents.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
16:30
PTF4
Professional Techniques - Foundation
Participant Profile
The workshop is aimed towards medical writers at all levels of experience, and whether working in a freelance capacity, or within a CRO environment, or for a pharmaceutical company. It will be an ideal forum for those who either have no quality control (QC) system in place, or are looking to develop one, whilst those with experience of working with, or implementing QC systems will be able to explore and share best practice. It is not necessary to have attended any other workshops.Objectives
For a medical writer the correct application of a QC process minimises errors in the factual presentation of data, rectifies spelling mistakes and ensures accurate document structure. At the end of the workshop, participants should have an understanding of why it is important to have a QC procedure in place for written documents including clinical study reports, when in the writing process QC should be implemented, and how to document the results. The need to incorporate a robust QC process to support consistent reporting of clinical trial results entering the public domain will be explored.Content
The importance of QC in medical writing will be covered. The consequences of not implementing and following a QC process will be discussed. QC requirements, who should perform the task, and how to carry it out will all be addressed. The workshop is designed to both inform and share experiences and interaction of participants will be actively encouraged. Although the workshop is applicable to other types of medical writing it will use clinical study reports as working examples.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
16:30
MCF31
Medical Communication - Foundation
Participant Profile
This workshop is intended for medical writers of all levels and specialties. Prior experience as a medical writer is not required. The concepts covered in this workshop can be helpful to even the most experienced medical writers.Objectives
Many medical writers, especially people new to the field, have difficulty coming up with a clear focus for their projects and developing them into a coherent document that accomplishes its objectives. This workshop provides a structured approach to conceptualizing and progressively building the content of any document.Content
Attendees will choose a document type to work on (e.g., study report, press release, manuscript, white paper, slide deck). Using materials provided during the pre-workshop assignment, they will learn to formulate a concise concept for their document using the problem statement approach. They will then learn to progressively develop the problem statement into a high-level outline, detailed outline, and draft document. This workshop will include a combination of lectures, exercises, and discussions.Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 1:30hrs
to
17:00
MCA4
Medical Communication - Advanced
Participant Profile
Participants should have some experience with writing scientific papers. The workshop is relevant for those who write or edit papers for others, and for those who wish to improve their own papers.Objectives
To increase the likelihood of producing focused – on a clear purpose statement – coherent research papers with well-structured in-depth argumentation.Content
Participants will learn to create a storyline, to clarify how a study fits into and strengthens the body of knowledge within a field, to distinguish clearly between the introduction and discussion sections, and to develop logical method-centred arguments in the discussion. We will discuss aspects of an example paper – long-term follow-up of breast cancer treatment – and suggested revisions of it, in groups and in plenum. Participants will receive the paper and suggestions before the workshop. Other topics are MICOT (material, investigative approach, comparator, outcome and timing) and a 6-step publication-planning-and writing process.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:30hrs
to
17:00
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
17:00
DDA28a
Drug Development - Advanced
Participant Profile
The Investigational Medicinal Product Dossier (IMPD) is an important component of the clinical trial application (CTA) which is submitted for approval of clinical trials on 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.Participants of this workshop will be expected to have basic knowledge, if not experience, of the drug development and approval process, especially in the US and the EU.
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. In addition, participants will be informed about the medical writer’s role in the preparation of the IMPD.Content
The IMPD includes summaries of information related to the quality, manufacture and control of the IMP; also included is a summarisation of data from non-clinical and clinical studies. 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 forms part of the IMPD.The main focus of the workshop will be to clarify the medical writer’s role in the selection, assembly, and summarisation of relevant source documents for drafting an IMPD; and in identification of whether a full or simplified IMPD is required. The workshop has a strong emphasis on the chemistry, manufacturing, and quality control (CMC) of chemical IMPs.
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
DDF36b
Participant Profile
This basic workshop is intended for participants directly or indirectly involved in the planning, analysis and/or reporting of clinical trials, or in the design of clinical development programs, or those with little or no background in this area who are interested in learning the basics. Previous experience or background knowledge of clinical trial disclosure is not required. This workshop will benefit newcomers to the topic, but also those simply wishing to update their knowledge of this topic.Objectives
Attending this workshop will help participants to understand the regulatory requirements (e.g., EMA Policies 043 and 070, the EU Clinical Trials Regulation [EU CTR], and national Freedom of Information laws) and industry commitments for clinical trial disclosure, understand how patients and investigational sites may benefit from this disclosure, be introduced to the new documents required due to the disclosure (EMA Policy 070 anonymization report, protocol lay synopsis, lay summaries, etc.), be aware of the challenges created by clinical trial disclosure for when drafting clinical documents (e.g., protocols, clinical study reports), understand what is company confidential information, personal protected information, and data privacy, and understand how data privacy and confidential information is protected (e.g., using anonymization or redaction).Attending this basic workshop before attending one of the specialist workshops will enable participants to gain the most benefit from the advanced workshops.
Content
This will be an interactive workshop combining classical presentations with quizzes and exercises to introduce the topic. The aspects of clinical trial disclosure most relevant for medical writers, including potential new deliverables and challenges during protocol and CSR writing, will be highlighted. This workshop will enable attendees to embark upon workshops covering specialized topics such as the drafting of lay summaries, trial registration and results reporting in EudraCT/CTIS/clinicaltrials.gov, and the protection of protected personal data and commercially confidential data.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:00hrs
to
17:00
DDA35
Drug Development - Advanced
Participant Profile
This workshop is ideal for medical writers with experience in creating documents for regulatory or non-specialist readers. It is especially beneficial for medical writers involved in developing informed consent materials for potential study participants. Medical writers who may need to produce written information in lay language about the safety and contraceptive aspects of a drug in clinical research will find this workshop particularly useful. Ideally participants understand an investigator brochure and of a clinical trial protocol.Objectives
The purpose of the Informed Consent Form (ICF) is to provide potential study participants with a clear summary of the risks involved in the study. This information should be written in easy-to-understand language so that participants can make an informed decision whether to participate in a clinical trial. It is essential for project and trial teams in clinical research to regularly update this information. Medical writers with expertise in regulatory and lay language writing can contribute valuable skills in developing and updating the risk information.The goal of this workshop is to help participants gain a comprehensive understanding of the language, templates, processes, and tools needed to effectively develop and update safety and contraception information in lay language for informed consent purposes.
Content
The safety and contraception content in an ICF will be presented and discussed. There will be particular emphasis on the development of reproducible and harmonized side effect and contraception information. Other topics include recommended lay language terminology, tools, and process considerations.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:30hrs
Thursday 9 May
to
11:45
DDF13a
Drug Development - Foundation
Participant Profile
This workshop is aimed at writers who wish to learn about the concepts underlying clinical development (e.g. the standard sections of a study protocol aimed at proving efficacy or the literature on clinical trials of efficacy). The workshop is suitable for those setting out to write regulatory documents as well as those who already have experience in medical communications or medical publishing who wish to understand the concepts underlying experimental study design.Objectives
To raise basic understanding of both study design and study conduct issues and the importance of these for valid and relevant experiments in trials intended as confirmatory studies of efficacy.Content
This workshop focuses on the theoretical concepts underlying good design and not the process of either protocol or report generation, nor the wider content of these documents.The following topics are covered:
• The design characteristics of a confirmatory study of efficacy
• The relationship between the study objective, the study hypotheses, the choice of endpoint and choice of control group
• Factors governing the identification of the study population
• The basis of sample size and its relationship with ‘power’
• Robustness of data based on the example of the full analysis set (also known as ITT) and a per protocol analysis set
• Bias: blinding and randomising to treatment groups and identifying bias in data
• The relationship between statistical significance, clinical relevance and ‘generalisability’
There will be classroom-format presentations as well as group exercises. The approach is intuitive, not statistical.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Participant Profile
This workshop will be useful for anyone who wants to make their writing more effective.Objectives
The objective of the course is to help participants write clear, professional text that communicates effectively with their target audience. We will focus on writing for scientific/technical/medical audiences and touch on aspects of writing for patients and the general public. The skills taught are applicable to all types of written communication.Content
The workshop looks at the principles of effective writing, and how to use them to achieve your communication goals. Topics covered include:• Structure and style: the do’s and dont’s of effective writing
• Achieving clarity without ‘dumbing down’
• Common style traps in medical and scientific writing
• Writing for patients and the public
• Organising content effectively
• Say it concisely: tips for reducing word count
The course contains interactive class exercises, and learning points are illustrated using real examples of good and bad medical writing.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
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
to
12:15
DDA34
Drug Development - Advanced
Participant Profile
Regulatory Medical Writers involved in Briefing Document development or interested in this highly strategical document that shapes a product’s clinical development program. Experience in clinical study protocol writing or previous attendance of the EMWA workshop ’Basic Concepts of Study Design in Clinical Development’ (DDF13), is recommended.Objectives
Medical Writers play a key role in aligning the cross-functional input during briefing documents development. Attendees will acquire knowledge of the goals, interaction types and structure of Briefing Documents directed to the EMA and FDA, as well as strategical consideration to effectively lead and coordinate this multidisciplinary effort.Content
Participants will get a deep dive into Briefing Documents:· Health Authority interactions requiring Briefing Documents
· Formats, structure, and content of Briefing Documents (EMA, FDA)
A step-by-step guidance for Medical Writers to support the Briefing Document development will be provided:
· Writing support (e.g. defining the list of questions and the Sponsor’s position)
· Project management support: setting up a routemap, coordinating cross‑functional interactions, understanding timings, and managing and optimizing the production steps.
Challenges and pitfalls that might be encountered and how to overcome them will be discussed.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 3:00hrs
to
16:30
MCF32
Medical Communication - Foundation
Participant Profile
This workshop is aimed at medical writers who are at an initial stage of their career or those who want to learn more about how to handle advisory boards in the most effective way. No prerequisites needed, however this will be an interactive workshop and exchange of experiences with each other.Objectives
The objective of this workshop is to help plan, organize, moderate and report an advisory board. There is not much offer on this subject and there is a growing request from medical writers in consolidating and growing their knowledge on advisory boards.Content
We will be covering the different stages of an advisory board, from both the perspective of the organizer (usually a pharma client) and its management (usually an events/med comms agency).From the organizer perspective, we will focus on the needs assessment (why the advisory board is needed, who the audience is, what are the main objectives and desired outcomes).
Then we will share some content about the organization (timelines, invites, preparation of presentations, pre reads for the attendees, the advisory board itself)
And finally, the role of the medical writer: moderation, reporting and delivering a report/executive summary.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
16:30
PTF22
Professional Techniques - Foundation
Participant Profile
This workshop is aimed at company staff and freelance medical writers who are interested in learning how they can make an effective contribution to the protocol writing process by taking a leading role. Previous participation in the workshop on The Clinical Study Protocol is recommended.Objectives
The objective of this workshop is to present the process of study protocol preparation to medical writers as a type of project management. The emphasis will be on the process of how the medical writer can effectively lead the preparation, review, and finalization of a clinical study protocol as a member of a multifunctional team. Study protocol writing will not be discussed in detail.Upon completion of this workshop, participants should be better prepared to work efficiently within a complex and at times quickly changing environment.
Content
The workshop will cover the role of the medical writer in leading the protocol writing process as a member of a multifunctional team.Best practices (do’s and don’ts) will be covered showing how a medical writer can best lead the team through the different steps in the process (from the kick-off meeting with the study team to the finalisation of the document)... Useful tools and practical approaches that can make the process easier will be presented.
Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:30hrs
to
16:30
MCF34
Medical Communication - Foundation
Participant Profile
This workshop is designed for anyone in medical writing who wants to improve their skills in visual communication using infographics. No previous knowledge or workshop is required, some experience in design would be helpful but is not essential. All the software will be given during the workshop so there’s no need to buy any license as we will work with free tools.Objectives
The ability to communicate scientific and medical topics visually gives any medical writer an advantage and a chance to collaborate on a variety of projects and improve their portfolio. Given the emergence of new technologies, it is important to gain tools that cannot be easily replaced by AI. Infographics and complex displays of information including images are not yet easily achieved by this type of technology, positioning medical writers with visual communication skills in a more competent place.Content
This workshop will cover the process from the storytelling to the design of the infographic to effectively deliver the message. In the beginning, we will introduce concepts to define the audience and the goal. When the idea and message are clear, we will start with the design of the infographic layout, placing the different elements correctly; in this part, we will introduce design concepts, the idea of repetition, hierarchy, colour, and balance. We will use different free tools for design and illustration. The main goal of this workshop is to understand the process of building an infographic as a layer system. First, the message and the layout, disposition of the different concepts or topics we want to deliver; followed by finding the colours, fonts, and proper illustrations. We will also discuss resolution and different formats (RGB, CMYK) depending on the use of the infographic.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Participant Profile
As professional medical writers should be reporting guideline champions, this workshop is propaedeutic for any workshops on scientific journals or congresses publishing and highly helpful for regulatory writers.Objectives
The growing availability of guidelines and checklists makes identification and use of the most appropriate guidelines for any specific disclosure more difficult. This workshop will help the writer to identify what is available and understand how to choose and use the most appropriate guidelines for their purpose.Content
The Consolidated Standards of Reporting Trials (CONSORT) statement, issued in 2001, was the first example of a comprehensive and structured guideline on how to communicate the results of randomised clinical trials. In addition, different guidelines, and checklists to use for the results of observational, health outcome, quality of life, mixed-method, and many other types of studies have been published. To complement all of these, pharmaceutical companies have developed Good Publication Practices, individual editors have developed their guidelines, and most journals have their own instructions for authors. In this workshop, we will review the main guidelines to identify when and how they can be used by medical writers to improve the productivity and quality of their jobs.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Friday 10 May
to
11:45
DDF39
Drug Development - Foundation
Participant Profile
This workshop is for medical writers who would like to gain insight into the unique aspects of clinical trials conducted with healthy volunteers rather than patients (such as Phase 1, thorough QT, and bioequivalence studies).Objectives
Healthy volunteer studies make up a large proportion of studies in most clinical development programmes. Medical writers working on documents for these studies need to understand how they differ from clinical trials in patients. After attending this workshop, the participant will understand the design issues and data collected in healthy volunteer studies.Content
This workshop will cover the following topics for healthy volunteer studies:· Key regulatory guidance documents
· Populations studied
· Study designs and objectives
· Types of assessments
Note: Phase I studies in patients will not be covered.
Note: Content in this workshop was previously included in Workshop DDA18. (Medical Writing for Healthy Volunteer Studies)
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:00hrs
Participant Profile
The non-clinical study report (NCSR) is a comprehensive document that presents the findings and results of studies conducted on substances or products in preclinical or laboratory settings. Hence, those who stand to benefit from this workshop are regulatory personnel and scientific/medical writers in the pharmaceutical industry, those at CROs or medical writing agencies involved in regulatory documentation, or within academic groups/technology transfer departments at universities, etc.Participants of this workshop will be expected to have basic experience/knowledge of the drug development and approval process in the US and/or the EU, as well as familiarity with various components of the eCTD.
Objectives
Participants of this workshop will receive an overview of the regulatory guidelines and individual parts of the NCSR and relevant source documents, as well as submission requirements. Thereby, the medical writer’s role in the preparation of the NCSRs will be highlighted.Content
Non-clinical studies are a crucial element of the drug development process and are typically performed before any testing on human subjects (clinical trials). Non-clinical study reports summarise the development, safety, efficacy, and potential risks associated with a substance or product under investigation.The main focus of the workshop will be to clarify the medical writer’s role in the selection and assembly of relevant source documents when preparing an NCSR.
The workshop is planned to be interactive and will include discussion of participants’ questions submitted in their pre-workshop assignments as well as group activities throughout the workshop.
Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:30hrs
to
12:15
DDA1b
Drug Development - Advanced
Participant Profile
The course is intended for medical writers with little or no experience of writing clinical submission dossiers although participants should be familiar with the clinical development process and have had some experience of writing clinical study reports.Objectives
• To introduce participants to the preparation of clinical submission dossiers according to the CTD• To convey general principles and process of summary writing
• To facilitate understanding of the limits of the available regulatory guidance
Content
• Development and background of the CTD• Purpose and types of clinical summary documents
• CTD Module 2.5 (Clinical Overview)
• CTD Module 2.7 (Clinical Summary)
• Integrated summaries of efficacy and safety for the USA
Pre-Workshop Assignment Length: 4:00hrs
Post-Workshop Assignment Length: 4:00hrs
Participant Profile
Medical writers working in the clinical research organisation or pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers tasked with preparing or performing quality control checks on appendices for clinical study reports (CSRs). This is an ideal forum for writers whose organisations or clients provide little guidance on appendix requirements, beyond provision of ‘ICH Guideline E3: Structure and content of clinical study reports’ and, further, may facilitate improvement in existing analysis and reporting processes and procedures.Objectives
The integrated CSR is a multi-component document comprising a text-based report and associated appendices. The text-based sections of the CSR are often given prominence and priority over the appendices, leaving the medical writer with insufficient time and resources to complete this necessary component of a full, integrated CSR. The workshop discusses time-planning and proactivity for appendices compilation as well as all the contents of Section 14 plus Appendices 16.1 to 16.4 inclusive. After completing the workshop, participants will understand how to best schedule appendices compilation and will understand the necessary content of each individual appendix.Content
The following topics will be covered:• Why prepare CSR appendices?
• Best practice for CSR appendices using CORE Reference
• Content for CSR Section 14 and Appendices 16.1 - 16.4
• Hierarchical appendix filling structure
• Time-planning for appendices compilation
• Managing and tracking appendices contents
• Communication and management
• Scheduling appendices
• Narratives: administrative and management aspects
• Appendices for abbreviated CSRs
• Appendices for device study reports
• Electronic transfer of appendices
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:00hrs
to
12:15
MCF33
Medical Communication - Foundation
Participant Profile
Participants should be broadly familiar with the types of “traditional” publications – abstracts, posters, oral presentations and manuscripts. No previous experience in developing or using enhanced content is necessary.Objectives
This workshop aims to educate attendees on the most commonly utilised forms of enhanced content available to accompany traditional publications (e.g. author interviews, animated summaries, graphical abstracts, plain language summaries) and discuss how these can be incorporated into the project flow.Content
The workshop will give an overview of the various types of enhanced content that could be developed to accompany a publication, when these might be appropriate and the benefits and drawbacks of each. We will also discuss aspects of project management when developing these materials, common barriers to their uptake and discuss approaches to overcome these.Please note that this workshop will not teach specialist techniques used to physically develop the materials (e.g. use of any specialist design software).
Pre-Workshop Assignment Length: 0:30hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:15
PTA2
Professional Techniques - Advanced
Participant Profile
Delegates should include medical writers, particularly those who work within, or for, pharmaceutical companies; project managers (whether by actual title or function); and others with responsibility for overseeing and coordinating multifunctional projects. Participants should have at least 1 year’s experience working within a matrix environment.Objectives
• Acquire understanding of basic project management theory• Apply project management theory to multifunctional projects
• Broaden context beyond medical writing
• Add team-building strategies
Content
Discussion will include project management theory and practical applications, both within the context of a matrix organisation, and as an independent providing services to clients. A medical writing group may also adopt these practices to better control their own destiny.This workshop will be a combination of lecture and in-class exercise, and will include discussions based on analysis of the scenarios presented in the homework. While the majority of the presentation will be didactic, there will be opportunity for attendees to share their experiences and ask questions throughout the presentation.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:15
MCA7a
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 (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 stakeholders (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 provide a comprehensive introduction to the requirements for creating lay language summaries of study results, as per EU regulation. We will explore the content requirements for lay summaries and discuss potential approaches to meet these requirements. We will also touch upon the basic principles of plain language writing as detailed in the ISO plain language standard 24495. The workshop will also highlight the importance of patient involvement in the writing and review process of lay summaries. Additionally, the workshop will cover the translation and distribution of lay summaries. We will also demonstrate other formats such as comics and videos. Throughout the workshop, we'll use specific examples to illustrate key points and facilitate a deeper understanding of the topic. This hands-on approach will ensure participants leave with practical knowledge they can immediately apply in their roles.Pre-Workshop Assignment Length: 2:30hrs
Post-Workshop Assignment Length: 3:00hrs
to
17:00
LWF13+14
Language and Writing - Foundation
Participant Profile
Note this is a double workshop. You must register for both parts.The workshop is intended for medical writers who edit or proofread their own work or that of their colleagues. It is not intended for people who specialise in medical editing. Previous attendance at another workshop is not required.
Objectives
This workshop aims to give an overview of editing and proofreading. After completing this workshop, participants should be able to:· Appreciate how editing and proofreading contribute to document quality.
· Identify and correct substantive and technical errors.
· Proofread and clearly show changes that need to be made.
· Understand how style guides, checklists and other tools can help with editing and proofreading.
Content
In this workshop, we will:· Review the need for both editing and proofreading.
· Focus on substantive editing: reorganising and editing to ensure that the correct message is delivered effectively and specifications are met.
· Discuss how to work effectively with authors.
· Focus on technical editing: getting down to the detail, including checking for format and consistency.
· Look at proofreading, to give a ‘final polish’.
· Consider tools to help the editor.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 4:00hrs
to
10:30
Expert Discussion Group - Not for credit
Content
Master protocol studies have a single overarching design developed to evaluate multiple hypotheses and improve study efficiency through standardization and uniformity. In drug development, these designs have become more commonplace, as experience during the COVID-19 pandemic has shown them to be more efficient than running multiple studies independently. Most study teams have limited experience in designing master protocol studies, thus protocol development remains a challenge. This Expert Discussion Group aims to focus on best practice for master protocol development, as well as sharing any experiences to date. Topics that will be covered will include terminology and regulations, establishing/refining a study outline (aka synopsis), preparing to start protocol writing, and managing stakeholders and timelines.to
16:30
MCF8b
Medical Communication - Foundation
Participant Profile
This workshop is aimed at, but not limited to, any medical writer working on manuscripts based on clinical study data. This is a foundation course aimed at gaining a basic understanding of how to effectively develop manuscripts based on trials (RCTs are used as the example throughout) using the CSR as the main data source.Objectives
After completing the workshop, participants will have an understanding of what tools are required to write a manuscript from the data presented in the CSR. They will have discussed source data and where to find it; differences in the presentation of data in a manuscript compared with a CSR; information that should never be left our based on the relevant guidelines (CONSORT will be discussed in more detail) and instructions to authors. They will have also have an understanding of figures and tables to include and how to choose and change them to be fit for purpose. This workshop does not cover Journal submission activities.Content
· Background on manuscripts based on CSRs; who is the audience?· Background on CSRs and the relevant sections to concentrate on for manuscript writing
· Tools and information you will need to get started (checklist exercise)
· Guidelines (general and CONSORT [as example])
· What to put where (CSR section exercise)
· Thinking about figures and tables (CSR to manuscript exercise)
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
15:00
Expert Discussion Group
Content
The buzz around the arrival and potential uses of generative AI in MedComms is inescapable. While many professional bodies, including the International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME), have set out guidelines aimed at steering the ethical incorporation of AI, the exact application of these is still open to interpretation.This discussion group is aimed at sharing our own experiences of incorporating genAI into our work so far, and how best to interpret the guidelines with respect to disclosing the use of AI.
to
16:30
PTF21
Professional Techniques - Foundation
Participant Profile
This workshop is aimed at medical writers who deal with health-related quality of life instruments (HRQoL) or patient-reported outcome measures (PROMs) in clinical studies or document writing. No prior experience with HRQoL instruments is needed.Objectives
The workshop will give an overview of the different types of HRQoL instruments and the main issues to be considered when using these measures in clinical studies. Participants will gain an understanding of how to appraise HRQoL measures and report their use in studies. We will also explore various approaches for generating the HRQoL data that are used in cost-utility analysis.Content
1. What is HRQoL and how can it be measured? (e.g. generic vs. specific, profile vs. preference-based measures)2. Reporting standards for HRQoL data (CONSORT-PRO and Chassany et al.)
3. Methods for generating preference-based value sets for use in cost-utility analysis and some of the challenges that arise.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
16:30
MCF35
Medical Communication - Foundation
Participant Profile
This workshop is suitable for participants of all levels who want to develop more effective posters. Previous experience in this area is not required; participants will benefit from this workshop whether they are already working in medical publications and would like to improve their skills, or are looking to move into this area.Objectives
The objective of the workshop is to guide participants on how to produce engaging scientific posters (and what not to do). The workshop will consider the purpose of posters as a means of communicating scientific findings, and how this can best be achieved through the use of effective data presentation and eye-catching design. Best practices and approaches to project management will also be discussed.Content
Through a mixture of lectures, interactive group activities, and discussions, participants will learn:· Tools to create engaging and impactful scientific posters
· How to go from abstract to poster
· How to prioritise information to avoid overcrowding a poster
· Basics of poster design
· Practical approaches to managing poster development projects
· How to gain maximum engagement and communicate the key messages
Pre-Workshop Assignment Length: hrs
Post-Workshop Assignment Length: hrs
Participant Profile
This workshop is primarily intended for medical writers who write publications, posters, or conference presentations and who want to improve their abstract writing skills. Medical writers who write summaries that must fit strict format and word limits can also benefit from this workshop. Participants should have some experience writing manuscripts, posters, or conference presentations.Objectives
A well-written abstract allows a reader to quickly understand what an article, poster, or presentation is about, and in many cases, they are the only thing they see. They are also used by journal editors to determine whether to select a manuscript for publication and by conference committees to determine whether a study warrants an oral presentation. Therefore, the abstract needs to capture the reader’s interest and transmit the key messages and information, all within strict limitations of length and format. This can pose a significant challenge, even to experienced writers.The objective of this workshop is to learn to identify and condense the key information from a study into the limited number of words and appropriate format for an abstract.Content
Participants will learn about the purposes of abstracts; key considerations in abstract writing; the different kinds of abstracts and what they should and should not contain; problems in abstracts and how to avoid them; tricks for shortening text; and guidelines for abstracts.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:00hrs
to
17:00
DDF11a
Drug Development - Foundation
Participant Profile
This workshop is intended for medical writers who are familiar with the clinical development process but have no or limited experience in writing subject narratives for clinical study reports.Objectives
Participants will acquire knowledge of the requirements and criteria for writing subject narratives within the framework of relevant ICH guidelines. They will obtain an understanding of the narrative writing process, including sources of data, presentation of information, important functional groups contributing to the narratives, and techniques for narrative generation. This will enable the writer to prepare high-quality narratives and optimise narrative writing activities.Content
The following topics will be discussed during the first part of the workshop:• Relevant sections of the ICH guidelines, emphasising the purpose of narratives
• Definition of narrative criteria and categories
• Content, including sources of information and data, the role of clinical trial and pharmacovigilance databases, recycling of information from CIOMS forms
• The narrative writing process, including formats, templates, use of programmed data, coordination with other functional groups, quality control, tips for handling narratives in large studies
During the second part of the workshop participants will be divided into groups and asked to write a simple narrative based on tables and listings.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
PTA10
Professional Techniques - Advanced
Participant Profile
This workshop addresses writers dealing with or interested in areas of clinical research, such as psychiatry, pain, quality of life, or patient reported outcomes, where “soft” endpoints are often used to assess treatments. Participants should have at least 1 year of medical writing experience and should already have written a study report or a manuscript based on the results of clinical studies.Objectives
This workshop explains the use of assessments in treatment outcomes that cannot easily be measured objectively. Typical examples are patient or physician questionnaires and visual analogue scales. These are often used in psychiatry, pain studies, or quality of life research where objective measurements are not possible or difficult. The reporting of these “soft endpoints” has some pitfalls, often providing a huge amount of data that is difficult to analyze, interpret, and communicate. Given the growing importance of psychiatry and patient focused quality of life research, reporting outcomes of subjective scales and questionnaires are becoming more and more important for medical writers.Content
Why are “soft endpoints” used in clinical research? What are typical examples of questionnaires? How should the measurements be selected (validation, generic vs. specific measures, acceptance)? How can results be evaluated and interpreted, including calculation of scores and subscores, and frequently used statistical analyses? How can results be communicated effectively without overwhelming the reader by the sheer amount of data? What needs to be taken into account when interpreting and discussing the results of questionnaires?Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
PTA18
Professional Techniques - Advanced
Participant Profile
This workshop is beneficial for Medical Communicators/Medical Writers (MW) who lead in project development, resource for specific documents, possibly still author, or manage teams and resource tasks within those teams. Participants should have experience of leading projects, departments, teams or with the potential of moving into that role.Objectives
This workshop will detail and enhance stakeholder management and resource management within project teams when the MW is considered the lead in the production process. MWs will be in a position to better manage the projects that they are leading or resourcing following this workshop.Content
The structure of the workshop is proposed to be looking at different stages of document development, starting with pre-IND, then moving to study level documents, programme level and finally submission packages.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:30hrs
to
17:00
MDF8a
Medical Devices - Foundation
Participant Profile
This workshop is intended for medical writers with little or no experience in regulatory writing under the Medical Devices Regulation 2017/745 (EU MDR) who would like to learn how to prepare a compliant Clinical Evaluation Plan. There is no prerequisite to attend this workshop, but basic knowledge of clinical research methodology and medical device terminologies will be useful.Objectives
The Clinical Evaluation Plan (CEP) is a key document that provides the foundation on which the clinical evaluation of a medical device is based. The objective of this workshop is to introduce participants to the regulatory requirements for this document and provide them with an understanding of how a well-written CEP can streamline the clinical evaluation process.Content
The workshop will provide a detailed overview of the contents of the CEP required under EU MDR. Specific topics covered include determining the clinical evaluation strategy best suited to your medical device, special considerations for legacy devices and new development, identifying appropriate safety and performance measures, identifying suitable equivalent or benchmark devices, the Clinical Development Plan, and an initial assessment of PMCF needs. The workshop will include group exercises and examples for low, medium, and high-risk class devices.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Participant Profile
This workshop is intended for anyone interested in learning about ethical, compliant, and transparent behaviour in the preparation of peer-reviewed scholarly publications. It will focus on Good Publication Practice (GPP) recommendations and guidelines from committees, such as the Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE). These are particularly relevant for company-sponsored congress presentations and manuscripts. Participants should have a basic understanding of the publication process, from conception to submission.Objectives
To foster ethical and compliant behaviour in publications, and to enable writers to understand, appreciate, and apply the current industry-wide standards of good publication practices.Content
· Summary of the general pharma publication process & importance of transparency· Review of current guidelines and position statements regarding, amongst others:
o Authorship and contributions criteria
o Disclosures and conflicts of interest
o Copyright and intellectual property
· Group discussion on case studies
Pre-Workshop Assignment Length: 0:30hrs
Post-Workshop Assignment Length: 1:30hrs
Saturday 11 May
to
11:45
PTF18a
Professional Techniques - Foundation
Participant Profile
This workshop is suitable for any medical writer with an interest in writing for the internet, whether already involved in this type of writing or not.Objectives
Medical writers are increasingly asked to provide text for online use. The objective of this workshop is to outline the basic principles of writing for the internet. The emphasis is on understanding how online content differs to more traditional media. We will NOT cover technical aspects such as website design, style sheets, coding, hosting, and related issues.Content
We will review the basic principles of writing for the internet and consider how it differs from writing for print. How readers use the internet and the visual and structural aspects of presenting information online are also covered. We will examine different online writing structures such as the inverted pyramid technique. The importance of headings and sub-headings are also outlined. Other topics such as Search Engine Optimisation (SEO), metadata and calls to action will also be briefly touched upon. The workshop includes practical exercises on creating internet text.Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:00hrs
to
11:45
PTF41
Professional Techniques - Foundation
Participant Profile
This workshop is aimed at medical writers who would like to improve their understanding of statistics. Prior attendance at “Basics of medical statistics for medical writers part 1” is not required; however, it is assumed that participants are already familiar with basic statistical concepts such as P values and estimation. Anyone who is not confident in their understanding of such concepts is encouraged to attend “Basics of medical statistics for medical writers part 1” before taking this workshop.Objectives
To help medical writers to understand the some of the statistical techniques used in clinical research (both in clinical trials and epidemiological research).Content
· Brief review of the basics: P values, confidence intervals etc· Regression analysis
· Intent to treat and per protocol analyses
· Missing data
· Interim analyses
· Primary and secondary analyses
The workshop will focus on what medical writers need to know about statistics to be able to present them in reports and publications, and not on mathematical details.
Please note that there is some overlap between this workshop and workshop PTF40, "Statistical testing". However, anyone interested in learning more about statistics should not be afraid of attending both workshops, as the material will be presented in different ways, which can often be a helpful way of consolidating learning.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:30hrs
Participant Profile
This workshop is aimed at medical writers, both new and experienced, who need to understand the basics of pharmacokinetics. Participants will normally have had little if any previous formal instruction in pharmacokinetics, or may not have understood what instruction they have received (or may even have received such instruction before they realised they would need it).Objectives
The objective of this workshop is to demystify pharmacokinetics for those who are terrified of mathematics. On completing the workshop participants should understand the meanings of some of the key terms and symbols used in pharmacokinetics, have some understanding of what the different terms tell us about the properties of drugs and be able to write competently about basic pharmacokinetics.Content
Participants will be given straightforward explanations and derivations of the key pharmacokinetic principles and equations. These explanations will be largely conceptual rather than mathematical, with worrisome mathematical terms and techniques explained in simple terms.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 3:00hrs
Participant Profile
Medical writers working in the pharmaceutical, biotech, healthcare or other related industries who would like to know more about the best practices for medical congress coverage. There are no prerequisites for the workshop.Objectives
Some of the most common research deliverables (i.e. abstracts, posters, and slide decks) are presented throughout the year at scientific congresses. Although medical writers can produce these documents, they may also need to attend the congress and develop a congress coverage report. Participants in this workshop will gain an understanding of how to develop key resources before arriving onsite, how to use technology to their advantage at the meeting, and how to capture key messages in their reports.Content
The workshop will begin with the basics of scientific congresses and consider all aspects of preparation, including pre-congress planning, project management, logistics, and best practices. We will then examine the use of technologies and apps to facilitate gathering information. Finally, the different types/styles of congress reports will be explained.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
11:45
MDF10
Medical Devices - Foundation
Participant Profile
This workshop is aimed at medical writers working in the regulatory field. Basic knowledge of regulations governing medicinal products and medical devices will be useful. Having completed the workshop Going from Pharma to Medical Devices would be helpful but is not a prerequisite.Objectives
The objective of this course is to provide an introduction to the regulations governing combination products (with focus on drug-device combinations [DDCs]) as they are defined in the US and EU, respectively. Additionally, we will touch on the documentation required for these types of submissions and the role of medical writers in developing these documents.Content
Combination products are regulated differently depending on their “Primary Mode of Action (PMOA),” their product configuration, and the regulatory body. Understanding how a combination product is regulated will be essential in understanding the documentation required in the regulatory submission. In the US, the submission process is different compared to that in the EU – however, much of the content is already an existing part of the technical documentation of the device and drug component, regardless of jurisdiction.This workshop will provide an introduction to combination products and the different types. We will cover the parts of a US submission and an EU submission, depending on the combination product PMOA, that are relevant to medical writing.
A few case-studies will be presented and discussed.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 3:00hrs
Participant Profile
This workshop is for participants who wish to develop or refresh their understanding of how basic statistical testing procedures work.Participants should:
· be familiar with basic arithmetic, including squares and square roots
· bring a calculator or smartphone app capable of square and square root functions
· come prepared to engage in exercises and discussions
Objectives
Non-statisticians often see statistical testing as a black box, into which statisticians pour numbers, to make p-values for medical writers to report. The underlying mathematics can appear intimidating, so this workshop breaks down the elements of some basic statistical tests, to illustrate how they work and what factors influence the results. Participants will gain a greater appreciation of how the outputs of statistical tests are generated, and what real-world decisions influence the likelihood of a significant outcome. This understanding will support their work when reporting statistical results.This is a highly interactive workshop which includes four group exercises.
Content
This workshop addresses the following areas:· Why we need statistical tests
· Populations and samples
· Continuous and categorical variables
· Describing continuous data
· Normal distribution
· Hypothesis testing
· Test on continuous data (Student’s t)
· Confidence intervals
· Test on categorical data (chi-square)
· Statistical significance and clinical relevance
· Type II errors (sample sizes)
· Data errors, recall bias, multiple testing
Participants should note that this workshop focuses in depth on statistical testing. The concepts of mean, standard deviation, and the normal distribution are covered briefly as these are essential to the working of many tests. Participants seeking more in-depth coverage of mean, standard deviation, normal distribution, and other fundamental issues should also consider taking workshop PTF30a.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:15
MCF21
Medical Communication - Foundation
Participant Profile
• Medical writers that have worked primarily on the regulatory side with a desire toexpand 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 gettingpharmaceutical 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 anoverview 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