55th EMWA Conference - Prague
9-13 May 2023
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 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 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.
The EMWA EPDC are excited to announce the new offering that will be piloted at this conference. We are launching Expert Discussion Groups (EDG), led by experts for our very experienced members.
The discussion groups will be led by an expert moderator who will choose the subject and 2-3 relevant questions to guide discussion. He or she 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 10 May
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
to
11:45
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
12:15
DDF36
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
12:15
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
12:15
MDF8
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
to
12:15
DDA33
Drug Development - Advanced
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
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
to
12:15
DDF33+34b
Drug Development - Foundation
Participant Profile
This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).Objectives
The objective of this workshop is to equip you with the essential skills required for the management and preparation of high quality CSRs. This includes in-depth sessions on both the writing of CSRs as well as their project management. The workshop will include group exercises and discussions so that participants can develop new skills attained and learn from each other’s experiences.This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the production of CSRs.
Content
The course will cover:• CSR project preparation and timelines
• Writing a CSR according to International Conference on Harmonisation (ICH) E3 guidelines and CORE reference
• Writing the methods sections: brief overview and advice
• Interpreting data, describing results: demography and baseline characteristics
• Interpreting data, describing results: efficacy; using the statistical report
• Interpreting data, describing results: safety and safety narratives
• Different types of CSRs: abbreviated CSR, full CSR, post-marketing reports, medical device reports
• CSR review and quality control
• Appendices: an overview
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:15
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
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
Participant Profile
EMWA delegates are required to be able to answer ‘yes’ to the below 3 questions in order to register for this session:1. Have you been a professional medical writer for ≥10 years?
2. Do you remember personally navigating a journey using a paper map?
3. Do you have an interest in, and have been following AI developments enough to be able to discuss the opportunities and challenges for medical writers?
Content
· Not so new artificial intelligence: discussion on how long medical writers have been reliant on AI· Where we are now: the fundamental impact ChatGPT has had on how we see AI
· Opportunities: how we can use AI in medical writing
· Risks, ethics, and limitations: uncertainties, implications, and risks in medical writing, the dark side of AI
· Our profession: awareness, preparedness, dynamism and regulation – adapting to change
Thought-provoking questions (be ready to actively contribute)
1. For how long have medical writers been reliant on AI?
2. How has ChatGPT created a paradigm shift?
3. What are the opportunities for medical writers? What risks and limitations should we be aware of?
4. How does our profession need to adapt?
to
16:30
PTF28
Professional Techniques - Foundation
Participant Profile
This workshop is aimed at medical writers looking to begin using Microsoft PowerPoint, or to refresh their basic skills.Objectives
The objective of the workshop is to give an overview of some of the functions of Microsoft PowerPoint, beginning from the very basics, and provide a practical guide to their use. There will be several hands-on exercises during the workshop for which a laptop with PowerPoint installed would be very helpful, although is not essential.Content
The workshop will begin with the basics of creating a new slideshow, adjusting slide formatting and using master slides, and inserting text and graphics. We will then examine the use of graphs for optimal display of data, animations and how best to animate graphs to enhance the presentation of scientific data, and tips and tricks for efficient and tidy slide design.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:00hrs
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
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
Objectives
The intention of this workshop is to educate medical writers & communicators on the basic 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
to
16:30
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
to
17:00
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
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
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
Thursday 11 May
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 more detailed information on some of the most common (e.g. clinical study protocols and reports, investigator brochures, CTDs, manuscripts, posters)
• 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.
to
11:45
MSF6
Medical Science - Foundation
Participant Profile
Participants should, ideally, have already completed Introduction to Pharmacokinetics (DDF7) and Pharmacology for Medical Writers: Part 1 – The Basics (MSF1), or have equivalent experience or knowledge.Objectives
This workshop is designed to explain the reasons behind the commonest types of adverse effects of drugs and medicines. This is intended to enable participants to understand and often predict adverse effects of new drugs and medicines. This will make it easier for participants to write accurately and effectively about the adverse effects of the drugs and medicines they will meet in their work.Content
All effective drugs (and hence the medicines that contain them) have adverse effects. To be useful, therefore, the effective (i.e. therapeutic) dose of a drug or medicine must produce only acceptable adverse effects. Adverse effects can arise in several ways, and this workshop seeks to describe these in a systematic way. The mechanisms can be broadly summarised as follows:(1) Extended normal pharmacology
(2) Parallel pharmacology
(3) Idiosyncratic reaction
(4) Pharmaceutical
(5) Pharmacokinetic interaction
(6) Pharmacological interaction
(7) Chemical interaction
Each of these mechanisms will be described with suitable examples, and the clinical significance of the different types of interaction will be discussed. Because of its largely factual content, the workshop will be mainly didactic. However, attendees will be expected to participate by answering questions as the presenter develops the explanations.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
Participant Profile
This workshop is primarily intended for medical writers who write publications, posters, or conference presentations and who want to improve their abstract writing skills. Medical writers who write summaries that must fit strict format and word limits can also benefit from this workshop. Participants should have some experience writing manuscripts, posters, or conference presentations.Objectives
A well-written abstract allows a reader to quickly understand what an article, poster, or presentation is about, and in many cases, they are the only thing they see. They are also used by journal editors to determine whether to select a manuscript for publication and by conference committees to determine whether a study warrants an oral presentation. Therefore, the abstract needs to capture the reader’s interest and transmit the key messages and information, all within strict limitations of length and format. This can pose a significant challenge, even to experienced writers.The objective of this workshop is to learn to identify and condense the key information from a study into the limited number of words and appropriate format for an abstract.Content
Participants will learn about the purposes of abstracts; key considerations in abstract writing; the different kinds of abstracts and what they should and should not contain; problems in abstracts and how to avoid them; tricks for shortening text; and guidelines for abstracts.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:00hrs
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
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
16:30
PTF13
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
to
17:00
DDF38d
Drug Development - Foundation
Participant Profile
Regulatory medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers, who write or review clinical study reports (CSRs). The workshop will meet the needs of writers and reviewers in interpreting existing International Council for Harmonisation (ICH) guidelines that drive preparation of CSRs, and in ensuring that CSRs are written in accordance with the principles of responsible clinical trial data sharing. Participants must have written at least one CSR or reviewed several, and have working knowledge of International Council for Harmonisation (ICH) reporting guidelines.Objectives
The current ICH guidance on CSR authoring is ICH E3 (1995) and the 2012 Questions and Answers (Q & A) Revision document. Inconsistencies in interpretation require clarification, and indeed this is recognised specifically for ICH E3 in the 2012 Q & A document. CORE Reference (see http://www.core-reference.org/) launched on 03 May 2016, provides interpretational guidance on CSR authoring that incorporates regional (EU and US) and real-world insights. These include guidance on writing CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements. Participants will acquire the knowledge and skills required to author or review fit-for-purpose CSRs that belong in the modern drug development arena.Content
· Background to CORE Reference· Description of CORE Reference complete web-based resource· Common inconsistencies in ICH guideline interpretation and how CORE Reference addresses these issues
· Background to transparency and public disclosure requirements
· How CORE Reference deals with the challenges of responsible clinical trial data sharing.
Pre-Workshop Assignment Length: 3:00hrs
Post-Workshop Assignment Length: 3:00hrs
to
17:00
DDA24b
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
Friday 12 May
to
11:45
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
Participant Profile
This workshop is intended for scientific/medical writers with little or no background in virology, or those interested in refreshing or updating their knowledge on the fundamentals of the subject. It is particularly relevant for writers working in such areas as infectious diseases, vaccines, and immunology. Participants should already have a basic understanding of molecular biology (DNA - RNA - protein).Objectives
To enable writers to understand and appreciate the basic principles of virology, and how these principles are applied in the medical sciencesContent
The workshop will cover the following topics:· Brief history of virology
· Relevant virology terminology
· Structure and function of viruses
· Viral diseases and their prevention and control
· Emerging topics: Corona vaccines and therapeutic applications of virology
Pre-Workshop Assignment Length: 0:30hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:15
PTF8
Professional Techniques - Foundation
Participant Profile
Anyone who wishes to explore how to recognise a cultural issue or problem (particularly in a medical writing setting) and how to approach it wisely. Curiosity and willingness to share own experiences are the most important prerequisites.Objectives
By raising awareness about cultural differences and key factors involved in intercultural communication, this workshop aims at giving participants an increased ability to recognise cultural issues in situations that medical writers frequently encounter, and the basic skills needed to avoid potential problems.Content
The ability to operate effectively in multicultural contexts has become a key business skill. Medical writers often work in international teams and many of us have experienced different working styles and ways of communicating that can create a host of problems. Knowledge about cultural characteristics and differences, and how they affect medical writing can diminish these problems. The workshop will be a mixture of lecturing, discussions and group work. The most common ways of distinguishing cultures from each other (national and organisational) will be covered and the pre-workshop assignment (the Enneagram’s nine personality types) will help to raise awareness about one’s own personal inclination to meet an unknown culture. Discussion groups will be put together from information given in the pre-workshop assignment.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 1:30hrs
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
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
to
12:15
DDA32
Drug Development - Advanced
Participant Profile
This workshop is for medical writers who would like to obtain knowledge about the Development Safety Update Report (DSUR). Participants should have some experience of collection and analysis of safety data, and an understanding of safety monitoring during clinical trials. Participants without this knowledge or without experience in safety/pharmacovigilance writing should in advance attend the course DDF32.Objectives
This workshop will provide participants with a comprehensive overview and the knowledge needed to write a DSUR. Starting with the DSUR’s regulatory background, purpose, and goal, the workshop will guide participants through the DSUR requirements, document content, the preparation and writing process.Content
Since 2011, DSURs are required in the ICH region for all marketed drugs or drugs under development for which clinical trials are ongoing. The aim of this workshop is to explain what the DSUR is, when it needs to be written (and when possibly not), which data and information need to be included and how to present them. It also provides guidance on the writing and project management process, taking into account that the DSUR is a document that requires an interdisciplinary and well-organised team effort within challenging timelines. Concise as per guidance, with a clear and logical structure, the DSUR nevertheless has some pitfalls in store that are also discussed in this workshop. To bring life and colour to the theory, all of this is illustrated with examples from the daily practice of preparing and writing DSURs.Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:00hrs
Participant Profile
This workshop is intended for medical writers (and others) who are interested in research and development of new medicines, and how decisions are made about how these are provided to patients. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical research, healthcare, and medical ethics will be provided for interactive discussion.Objectives
To give an overview of the various ethical considerations associated with conducting clinical trials, and associated policies and processes, including institutional oversight, pre-approval access, regulatory authority clearance, subject informed consent, investigatory conflict of interest, issues of fraud, and ensuring subject safety and well-being.Content
This workshop will consist of a combination of presentations on the evolution of ethical principles associated with human subject participation; relevant ethical issues, with respect to clinical research and development, clinical trials, societal healthcare decisions; and group discussions on challenging ethical considerations of some “real-world” case studies. The presentations will focus on the importance of ethics in GCP, human subject protections, and the dynamic tension between the individual and societal needs. Practical experience will be shared with the participants.Pre-Workshop Assignment Length: 3:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
12:15
LWF21
Language and Writing - Foundation
Participant Profile
This workshop is for both native and non-native speakers of English who would like to write more clearly in English. Participants should have some experience of writing regulatory documents, peer-reviewed publications or patient material.Objectives
Medical writers worldwide need to convey scientific knowledge in technical documents, peer-reviewed publications or patient communications in clear, concise English in an increasingly time-pressed environment. Yet, many writers lack the skills to write English clearly, concisely and with the appropriate language and style. This workshop will provide specific writing tools and techniques that writers can apply to their writing to make their texts more precise and easy-to-read. After this workshop, participants will be more confident and better equipped to write more effectively in English.Content
The first part of this workshop will focus on precise word choice, sentence structure and tenses in medical writing. Participants will learn how to structure strong sentences in English and use specific techniques to self-correct their writing. The second part of the workshop will show how these language elements can be used to tell a story using concise and clearly constructed paragraphs and sections. Using guidelines and templates to facilitate story structures will also be discussed. Participants will be encouraged to participate actively in the workshop and will have the opportunity to practice the techniques learned.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: hrs
to
10:30
Participant Profile
EMWA delegates are required to be able to answer ‘yes’ to 2 of the 3 below questions in order to register for this session:1. Have you been a professional medical writer for ≥10 years?
2. Have you taken or know someone who has been treated with a product that was the subject of an accelerated regulatory assessment?
3. Do you have an interest in, and have been following developments in the area of accelerated assessments and specialized regulatory pathways enough to be able to discuss the opportunities and challenges for medical writers?
Thought-provoking questions (be ready to actively contribute
1. What types of accelerated reviews and special pathways are available for medicines in the EU?
2. Do the standards for quality, safety, efficacy and value differ between products that undergo a standard review vs those that benefit from an accelerated review?
3. Can patients and HCPs have confidence in the safety and efficacy of products that have undergone an accelerated assessment?
4. What considerations would you discuss in terms of the benefits and risks of products that have undergone an accelerated assessment with patients, HCPs and other stakeholders?
Content
· Almost every regulatory agency has special pathways to accelerate the review of important new medicines· This helps to ensure the availability of medicines for unmet medical needs
· However, there is controversy about the robustness of the data used to make the initial regulatory decision and how these products should be assessed post-approval
Thought-provoking questions (be ready to actively contribute)
1. What types of accelerated reviews and special pathways are available for medicines in the EU?
2. Do the standards for quality, safety, efficacy and value differ between products that undergo a standard review vs those that benefit from an accelerated review?
3. Can patients and HCPs have confidence in the safety and efficacy of products that have undergone an accelerated assessment?
4. What considerations would you discuss in terms of the benefits and risks of products that have undergone an accelerated assessment with patients, HCPs and other stakeholders?
to
15:00
Expert Discussion Group - Not for credit
Participant Profile
EMWA delegates are required to be able to answer ‘yes’ to the below questions in order to register for this session:1. Do you consider yourself to be an expert in the development of scientific manuscripts for publication?
2. Are you conversant to a professional level with ICMJE authorship criteria?
3. Have you read the 2022 update of the Good Publications Practice (GPP 22) guidelines (DeTora et al, Ann Intern Med. 2022; doi:10.7326/M22-1460)?
a. If not, reading this prior to the Discussion Group is recommended.
Thought-provoking questions (be ready to actively contribute
1. What are the benefits and challenges of working with patient authors, and if challenges, how do we begin to address these?
2. Which publications do you think most benefit from inclusion of a patient author in the author list?
3. At what stage should patient authors be included?
4. How might the manuscript development process need to be adapted when working with patient authors?
5. Should patient authors be reimbursed for their time and contributions?
Content
In recent years, the conversation surrounding inclusion of the patient voice into medical publications, especially as patient authors, has moved on from “should we?” to “how should we?”. The Discussion Group aims to facilitate discussion of the benefits and challenges of working with patient authors, as well as sharing any experiences to date within the group. Topics to be covered will include how patient authors can meet ICMJE criteria, practicalities of working with patient authors, on which publications this is most appropriate/beneficial, and emerging challenges such as reimbursement of patient authors.Thought-provoking questions (be ready to actively contribute)
1. What are the benefits and challenges of working with patient authors, and if challenges, how do we begin to address these?
2. Which publications do you think most benefit from inclusion of a patient author in the author list?
3. At what stage should patient authors be included?
4. How might the manuscript development process need to be adapted when working with patient authors?
5. Should patient authors be reimbursed for their time and contributions?
to
16:30
PTF30a
Professional Techniques - Foundation
Participant Profile
This workshop is aimed at medical writers who would like to improve their understanding of statistics. No previous knowledge of statistics is assumed, but a basic familiarity with what clinical trials are (eg experience with writing CSRs or publications of clinical trial results) would be helpful. Please note that this workshop is at a basic level and medical writers who are already experienced and confident in writing about statistical techniques may not benefit from it.Objectives
To help medical writers to understand the basic principles behind statistical analysis as used in clinical research (both in clinical trials and epidemiological research).Content
· Types of data· The normal distribution and other distributions
· Hypothesis testing and P-values
· Estimation and confidence intervals
· Measures of variability: standard deviations and standard errors
· Some common statistical tests
· Parametric and non-parametric tests
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.
This workshop is aimed at making sure medical writers who are not experienced with using statistics have a good understanding of the basics. The companion workshop "Basics of medical statistics for medical writers part 2" will cover some more advanced concepts.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00-3:00hrs
to
17:00
DDA29
Drug Development - Advanced
Participant Profile
This workshop addresses writers dealing with or interested in documents for non-interventional (observational) studies for epidemiology, real-life safety and efficacy, health economics, and quality of life. This is a development of the DDA 9 workshop with an emphasis on the new opportunities to design studies using existing clinical databases. Participants should have at least 2 years of medical writing experience with study related documents (e.g. protocol, CSR, scientific publication).Objectives
This workshop provides you with the definition of non-interventional studies, how they differ from randomized controlled clinical trials (RCT) and what is the regulatory background for these differences. The diversity of types of non-interventional studies will be explained, with special emphasis on recent study designs using existing clinical databases instead of study specific databases. It will be explained how documents for non-interventional studies are prepared by medical writers (in particular, protocols and study reports), and how writing differs from RCTs.Content
What is non-interventional research. Definition of non-interventional studies. Scientific Goals of Non-Interventional Studies. Different Designs of Non-interventional Studies. Use of Databases in Non-interventional Studies. Are Non-Interventional Studies Scientifically Valid? Documents for Non-interventional Studies, similarities and differences to RCT documents (SAP, Protocols, ICF, Reports, Publications, Transparency Reporting). Specific ways to describe Non-interventional Study design and study results. Differences in discussion and interpretation of the data compared to RCTs.Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 1:00hrs
to
17:00
MDF4
Medical Devices - Foundation
Participant Profile
This course is intended for medical writers with little or no experience in regulatory writing, including Post-market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports, under the Medical Devices Regulation 2017/745 (EU MDR). There is no prerequisite to attend this workshop but basic knowledge of clinical research and medical device terminologies will be useful.Objectives
With the introduction of the Medical Devices Regulation 2017/745 (EU MDR), each device (or device family) needs a specific PMCF Plan. The results of PMCF activities are summarized in a PMCF Evaluation Report. These documents are subject to predefined review cycles and depend on several other input documents. This course will give you profound insights into the regulatory requirements for PMCF, best practice recommendations on how to prepare PMCF Plans and Reports, and insights into common pitfalls and tips on how to avoid them.Content
The course includes an introduction to:· Annex XIV Part B of EU MDR 2017/745 (Post-Market Clinical Follow-up)
· MDCG (Medical Devices Coordination Group) Guidance on PMCF Plans (2020/7)
· The MDCG (Medical Devices Coordination Group) Guidance on PMCF Evaluation Reports (2020/8)
· Input documents and review cycles
· Different methods to conduct PMCF.
You will work with a fictional medical device to think about general and specific PMCF activities. You will also get insights into what triggers PMCF and how to avoid common pitfalls related to PMCF documentation.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
17:00
MCF1a
Medical Communication - Foundation
Participant Profile
Previous title: Writing Successful ManuscriptsThis 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
• Step-by-step instructions for preparing a manuscript
• The peer review process and how to learn to love it
• The role of the professional medical writer in manuscript writing
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 3:00hrs
to
17:00
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
DDF49
Drug Development - Foundation
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). Also presented will be implications of the Regulation EU 536/2014 and its portal Clinical Trials Information System (CTIS); differences between EudraCT and CTIS will be highlighted. 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
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 CTIS; explain differences between EudraCT and 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
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 CTIS; explain differences between EudraCT and 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
Saturday 13 May
to
11:45
PTF19
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
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
MDF7
Medical Devices - Foundation
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 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
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
to
12:15
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
12:15
DDA18a
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
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