50th EMWA Conference - Virtual
November 2020
Please note all timings for the EPDP Workshop Programme are in CET (Central European Time).
See Fees and Registration for details of fees and waiting list procedures for events (including EPDP workshops).
Before registering for a workshop, please click on its title and read the abstract.
Some workshops (including foundation ones) are designed for people with some knowledge or previous experience.
After registering for a workshop, download the pre-workshop assignment using the link on the right hand side of the workshop listing. Please note it is your responsibility to download the pre-workshop assignment(s) for the workshop(s) you are registered for. Head Office will not be distributing any pre-workshop assignments.
Saturday 7 November
to
12:15
DDF37
Drug Development - Foundation
Participant Profile
This workshop is for medical writers at different stages of their career. There is no prerequisite for participation but a basic knowledge of clinical trial documents is expected.Objectives
The EU Clinical Trial Regulation (CTR) and the EMA Policy 0070 require public disclosure of clinical trial (CT) documents. The EU General Data Protection Regulations (GDPR) requires that personal data in these documents be protected. Though divergent at first glance, these new sets of requirements are actually aligned to benefit patients. As medical writers, we need to find the right balance between disclosure and data protection while maintaining the scientific utility of the documents we write. The objective of this workshop is to help medical writers deal with different CT documents impacted by requirements for transparency and public disclosure and the GDPR. The participant will gain knowledge in identifying critical patient data and the “risk areas” of a CT document or project, and in mitigating risks to confidentiality and compliance.Content
The workshop will cover:· a short introduction to CT transparency and disclosure, the key regulations (i.e., EU CTR, EMA Policy 0070, GDPR), and definitions of key terms
· benefits, challenges, and risks of public disclosure
· CT documents impacted, with focus on the study protocol and the clinical study report
· personal data pseudonymisation (“redaction-friendly”) techniques at the document level
· working with other functional groups to ensure patient data protection in CT documents
· real life examples
· hands on exercises
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 2:30hrs
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
Monday 9 November
to
12:45
DDA28
Drug Development - Advanced
Participant Profile
The Investigational Medicinal Product Dossier (IMPD) is an important part of the clinical trial application (CTA) which is submitted to the EMA for approval of clinical trials of investigational medicinal products (IMPs) in the EU. Those who stand to benefit from this workshop are regulatory personnel and medical writers in the pharmaceutical industry, CROs, and medical writing agencies who are involved in preparing regulatory documentation – especially documents pertaining to the chemistry, manufacturing, and quality control (CMC) of IMPs.Participants of this workshop will be expected to have experience/knowledge of the drug development and approval process, especially in the US and the EU as well as familiarity with various components of the eCTD.
Objectives
Participants of this workshop will get an overview on the individual parts of the IMPD, as well as details of the relevant source documents and submission requirements and the medical writer’s role in the preparation of the dossier. Additionally, the workshop aims to inform participants on Blockchain technologies, implemented in Supply-Chain-Management, in clinical trials.Content
The IMPD includes summaries of information related to the quality, manufacture and control of the IMP, data from non-clinical studies and from its clinical use. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of the proposed study also have to be part of the IMPD.The main focus of the workshop will be to clarify the medical writer’s role in the selection, assembly, and summary of relevant source documents for drafting a full or simplified IMPD for medicinal drug products, with a strong emphasis on the chemistry, manufacturing, and quality control (CMC) components of these. Furthermore, the workshop aims to educate participants on recent Supply-Chain-Management developments in clinical trials, with focus on Blockchain technologies, required for the IMPD assembly.
The workshop is planned to be interactive and will include discussion of participants’ questions submitted in their pre-workshop assignments, where relevant. There will also be a handful of exercises carried out during the workshop to encourage overall participation.
Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:30hrs
to
16:30
PTF3
Professional Techniques - Foundation
Participant Profile
Medical writers and editors with any level of experience who wish to learn more about the statistics they work with.Objectives
At the end of the course participants should understand the following:· Populations to be analyzed: intent-to-treat, per-protocol, safety-evaluable, worst-case.
· Missing Data and Sensitivity Analyses
· Descriptive statistics: mean, median, mode, range, percentiles, box plot, normal and non-normal distributions, parametric and nonparametric tests, coefficient of variation
· Odds and Hazard Ratios
· Estimates and confidence intervals, and p-values
· Sample size calculations and what they mean
Content
We all write about statistics, but how many of us really have an intuitive feel for what we're writing about? This workshop is designed for participants who have little or no background in statistics. The following statistical concepts will be covered in depth: types of variables, levels of measurement, summary statistics, estimation and confidence intervals, and sample size calculations. Emphasis will be placed on understanding statistical presentations and reporting statistical information, not on calculations or mathematical explanations.Pre-Workshop Assignment Length: 4:00hrs
Post-Workshop Assignment Length: 1:00hrs
Tuesday 10 November
Participant Profile
As professional medical writers should be reporting guideline champions, this workshop is propaedeutic for any workshops on scientific journals or congresses publishing and highly helpful for regulatory writers.Objectives
The growing availability of guidelines and checklists makes identification and use of the most appropriate guidelines for any specific disclosure more difficult. This workshop will help the writer to identify what is available and understand how to choose and use the most appropriate guidelines for their purpose.Content
The Consolidated Standards of Reporting Trials (CONSORT) statement, issued in 2001, was the first example of a comprehensive and structured guideline on how to communicate the results of randomised clinical trials. In addition, different guidelines, and checklists to use for the results of observational, health outcome, quality of life, mixed-method, and many other types of studies have been published. To complement all of these, pharmaceutical companies have developed Good Publication Practices, individual editors have developed their guidelines, and most journals have their own instructions for authors. In this workshop, we will review the main guidelines to identify when and how they can be used by medical writers to improve the productivity and quality of their jobs.Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
to
16:30
DDF32
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
Wednesday 11 November
to
12:45
LWF13+14
Language and Writing - Foundation
Participant Profile
Note this is a double workshop. You must register for both parts.The workshop is intended for medical writers who edit or proofread their own work or that of their colleagues. It is not intended for people who specialise in medical editing. Previous attendance at another workshop is not required.
Objectives
This workshop aims to give an overview of editing and proofreading. After completing this workshop, participants should be able to:· Appreciate how editing and proofreading contribute to document quality.
· Identify and correct substantive and technical errors.
· Proofread and clearly show changes that need to be made.
· Understand how style guides, checklists and other tools can help with editing and proofreading.
Content
In this workshop, we will:· Review the need for both editing and proofreading.
· Focus on substantive editing: reorganising and editing to ensure that the correct message is delivered effectively and specifications are met.
· Discuss how to work effectively with authors.
· Focus on technical editing: getting down to the detail, including checking for format and consistency.
· Look at proofreading, to give a ‘final polish’.
· Consider tools to help the editor.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 4:00hrs
to
17:00
MDA1
Medical Devices - Advanced
Participant Profile
This workshop is intended for medical writers who are either interested in working with medical devices or who already work with medical devices and are involved in preparing literature reviews for clinical evaluation reports (CERs). Familiarity with European medical device regulations and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.Objectives
The aim of this workshop is to understand how to write a literature review as part of a CER. Participants will learn how to prepare a literature review to Medical Device Regulation (MDR) requirements.Content
The workshop will explain the following:· the role of the literature review in the clinical evaluation of a medical device;
· the scope of the literature review;
· developing literature search strategies for the subject device and state of the art (current knowledge);
· writing the state of the art section;
· screening and appraising the literature for the subject device;
· data extraction;
· analysing and presenting the literature in the CER;
· literature disposition;
· citing references and listing excluded references.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 3:00hrs
Thursday 12 November
to
12:45
LWF13+14
Language and Writing - Foundation
Participant Profile
Note this is a double workshop. You must register for both parts.The workshop is intended for medical writers who edit or proofread their own work or that of their colleagues. It is not intended for people who specialise in medical editing. Previous attendance at another workshop is not required.
Objectives
This workshop aims to give an overview of editing and proofreading. After completing this workshop, participants should be able to:· Appreciate how editing and proofreading contribute to document quality.
· Identify and correct substantive and technical errors.
· Proofread and clearly show changes that need to be made.
· Understand how style guides, checklists and other tools can help with editing and proofreading.
Content
In this workshop, we will:· Review the need for both editing and proofreading.
· Focus on substantive editing: reorganising and editing to ensure that the correct message is delivered effectively and specifications are met.
· Discuss how to work effectively with authors.
· Focus on technical editing: getting down to the detail, including checking for format and consistency.
· Look at proofreading, to give a ‘final polish’.
· Consider tools to help the editor.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 4:00hrs
to
18:30
LWA14
Language and Writing - Advanced
Participant Profile
This workshop, at an advanced level, is accessible to all medical writers interested in the journal article and syntactic clarity.Objectives
To enhance understanding the writing distractions pertinent to conceptual components of the journal article. The distractions are focused on syntactic intra-sentence structure and order of words, phrases, and clauses.Content
By the following 3-levels of activities, gain insight into syntactic distractions that are specific for the conceptual components of the medical journal article.(1) Pre-workshop: Complete a clarity-testing exercise. That is, from each of 12+ sets of paired sentences, select the clearer sentence and describe the primary distraction in the unselected sentence. After sending your selections (and justifications) and then receiving a guide to structure and order syntactic distractions, prepare to participate in the workshop.
(2) Workshop: For each set in the clarity-testing exercise, participate in a discussion with other registrants and the workshop facilitator. After the discussion of each set, the workshop facilitator will analyze and justify his decision, after which the vote tally will be revealed and followed by more discussion.
(3) Post-workshop: Comment on the distractions and revisions with which you still disagree.
Pre-Workshop Assignment Length: 2:30hrs
Post-Workshop Assignment Length: 2:30hrs
Friday 13 November
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
17:00
MDF2
Medical Devices - Foundation
Participant Profile
This workshop is primarily intended for medical writers who have some knowledge of regulatory guidance and are interested in working with medical devices. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.Objectives
The aim of this workshop is to understand the EU regulatory pathways, to become familiar with the documents used for medical devices to see these in the light of those used for pharma, and to identify transferable skills between pharma and medical devices.Content
The workshop will explain the following:· Definition of Terms: Pharma vs Medical Devices;
· The EU Regulatory Pathway: Pharma vs Medical Devices;
· Product development steps;
· Regulations and guidelines;
· The Documents: Pharma vs Medical Devices;
· Transferable Skills;
· Case Studies.
Pre-Workshop Assignment Length: 1:00hrs
Post-Workshop Assignment Length: 2:00hrs
Saturday 14 November
to
12:15
PTF1
Professional Techniques - Foundation
Participant Profile
Medical writers and editors with 0-4 years of experienceObjectives
At the end of the course participants should be able to:· Compose a table or graph when given data in raw form or in paragraph style
· Recognise the basic parts of a table and a graph and identify the various types of tables and graphs
· Understand the functions of tables and graphs
· Identify the strengths and weaknesses in the design of a given table or graph and be able to modify it accordingly
Content
The role of a medical writer is to be able to present data in the clearest and most understandable form possible. The best way to present and communicate with data, however, is not prose but rather using some form of graphical presentation. This course will challenge and stimulate the participants’ ability to think clearly about the data they present and write about. Participants will learn about the basic tools of data presentation, tables and graphs, their types and components, and when––and when NOT––to use them. It will introduce the participants to the fundamental tools of data presentation, tables and graphs in all their myriad forms and uses. This course is an introduction to data presentation and should be taken before taking Data Presentation II: Advanced Data Presentation.Pre-Workshop Assignment Length: 3:00hrs
Post-Workshop Assignment Length: 3:00hrs
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
Monday 16 November
to
12:45
DDF41
Drug Development - Foundation
Participant Profile
This workshop is aimed at new medical writers and experienced writers who are new to writing clinical study protocols.Objectives
The purpose of this workshop is to introduce medical writers to the components and concepts of a protocol, and to provide instruction on protocol writing. On completion of the workshop package, participants should feel confident about how to develop and write a protocol and how to manage the process.Content
The workshop will explain how to develop a protocol with practical examples and exercises. Participants will be introduced to the role of the study team in protocol writing. An outline will be given of regulations, guidelines, and sources of information. The pre-workshop assignment will be reviewed and used to build up a picture of the study. The influence of the study design on the protocol will be discussed. Development of the protocol synopsis will then be examined in detail, including discussion of study design and the relationship of the protocol with the Case Report Form.The workshop will then focus on the body of the protocol, i.e. filling in the details, including how to ensure that the study will be conducted as intended. This will be supplemented by the interactive workshop exercises, which are designed to get participants thinking in logical, practical sequence. The last part of the workshop will describe the ‘standard’ and administrative sections, appendices, and the ‘When, Why and How?’ of protocol amendments.
The workshop will then focus on the body of the protocol, i.e. filling in the details, including how to ensure that the study will be conducted as intended. This will be supplemented by the interactive workshop exercises, which are designed to get participants thinking in logical, practical sequence. The last part of the workshop will describe the ‘standard’ and administrative sections, appendices, and the ‘When, Why and How?’ of protocol amendments.
Pre-Workshop Assignment Length: 3:00hrs
Post-Workshop Assignment Length: 3:00hrs
to
17:00
DDA19
Drug Development - Advanced
Participant Profile
Participants should be familiar with the drug development process and have an understanding of basic pharmacokinetics.Objectives
After completing the workshop, participants will have an understanding of the strategic role PK/PD modelling plays in drug development. In addition, they will gain an appreciation of how modelling can influence the claims that can be made on the drug label. They will be better placed to discuss modelling issues within projects, and to incorporate modelling outcomes into reports and regulatory documents.Content
The rationale for modelling in drug development is presented, along with the regulatory view. Different modelling techniques (compartmental, population, pharmacokinetic/pharmacodynamic [PK/PD], physiologically based (PBPK) are discussed in terms of their principles, their role within a drug development programme, and common terms used in their execution. This is illustrated with examples from the literature and the presenter’s personal experience. How modelling output can influence the claims made on the drug label will be discussed. The workshop consists of modules interspersed with individual and group learning tasks.Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 2:00hrs
Tuesday 17 November
to
12:45
MCA7
Medical Communication - Advanced
Participant Profile
This workshop is for medical writers who want to engage in the writing of lay summaries of study results as mandated by the EU regulation. Participants should already have an understanding of CSR structure (ICH E3) and should know the basics of clinical research (trial design, efficacy and safety analysis, basic statistics).Objectives
Writing lay summaries is a difficult and challenging task. Medical writers with an interest in lay writing are well suited for this new and upcoming activity. However, the provision of lay summaries requires a lot more than good lay language writing. The workshop will introduce the many different aspects of providing lay summaries: the available regulatory guidance, the positions of various stake holders (pharma and patient organisations), the intricacies of the actual writing of lay summaries, and considerations for appropriate distribution of the lay summaries.Content
The workshop will introduce the requirements for lay language summaries of study results according to the EU regulation. The various guidance documents from stakeholders (TransCelerate, MRCT, European Expert Group) will be introduced and briefly discussed. The content requirements for lay summary will be presented and possible solutions will be presented for discussion. As lay language writing is difficult, only the basic principles of plain language writing will be covered. To learn about the complexity of lay language writing in a confined context, the workshop will have a practical exercise, as participants will be asked to write a short paragraph of a lay summary. In addition, methods for patient involvement into the writing and review of lay summaries will be introduced and the various distribution options for lay summaries as well as the issue of translations will be discussed.Pre-Workshop Assignment Length: 2:30hrs
Post-Workshop Assignment Length: 3:00hrs
Participant Profile
This workshop is intended for medical writers (and others) who are interested in clinical trials and would like to know more about the evolution of ethical principles associated with human subject participation. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical trial 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 relevant ethical issues, with respect to clinical trials, and group discussions on challenging ethical considerations of some “real-world” case studies. The presentations will focus on the importance of ethics in GCP, the informed consent process, and the challenges that may arise in developing countries. Practical experience will be shared with the participants.Pre-Workshop Assignment Length: 3:00hrs
Post-Workshop Assignment Length: 2:00hrs
Wednesday 18 November
to
12:45
MSF13
Medical Science - Foundation
Participant Profile
Any regulatory medical writer looking to understand the basics of cell signalling and how it can be used for modern drug development.Ideally, participants will have taken workshops MSF9 (The Fundamentals of Genetics for Medical Writers) and MSF1 (Pharmacology for Medical Writers: the Basics) or have an equivalent knowledge, but the basic concepts required are included in the pre-workshop assignment as a reminder.
Objectives
As medical writers, some knowledge of molecular biology (including cell signalling) is important in order to understand the molecular mechanism of action of a drug, which is the fundament for many clinical development programs.The aim of this workshop is to introduce basic concepts of signal transduction, how this knowledge can be used to develop new drugs, and how details about cellular signalling are described in regulatory documents and manuscripts.
Content
The basic theoretical concepts of cellular signalling will be introduced (forms of signalling, common signalling molecules, components of signalling cascades, etc). How the knowledge of these basic concepts can help drug development will be discussed. The molecular mechanism of action of several marketed drugs will be introduced and compared to the descriptions found in relevant regulatory documents (examples from the EMA database) and manuscripts.Pre-Workshop Assignment Length: 1:30hrs
Post-Workshop Assignment Length: 1:30hrs
to
16:30
PTF24
Professional Techniques - Foundation
Participant Profile
Medical writers often need access to up to date relevant information in order to complete their writing tasks. The workshop will be useful to all writers ranging from those working for pharmaceutical companies and CROs with large medical information departments, to freelance medical writers with no information support. This workshop was previously run under the code PTF2 but it has changed significantly.Objectives
The aim of this workshop is to enable writers:• to determine how and where to obtain the information they require
• to identify reliable information sources
• to be more confident and effective in searching the internet
Content
This workshop will discuss the different types of information sources available including on-line databases, and web sites. It will provide information on the different database providers, what type of information is available from on-line databases and how to choose the most relevant databases and web sites.It will provide tips on the use of search engines, including some specific medical search engines, and provide a practical example of how to use PubMed to search MEDLINE, (one of the major bibliographic databases for medicine).
The workshop will include a practical exercise in identifying appropriate sources to obtain information.
Attendees will need access to the internet in order to complete their pre-workshop assignment and post-workshop assignment. However no previous experience of internet use is required and access to fee based services will not be required.
Pre-Workshop Assignment Length: 2:00hrs
Post-Workshop Assignment Length: 3:00hrs
Thursday 19 November
to
12:45
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