Expert Seminar Series
The EMWA Expert Seminar Series (ESS) is for experienced medical writers, heads of medical writing departments, and industry leaders from other disciplines who want to learn about the latest developments affecting the medical writing industry and play a role in shaping the world of medical writing.
Wednesday 02 May
ContentRisk management plans (RMPs) and periodic safety update reports (PSURs): an evolving landscape with a wide impact for Pharmacovigilance Writers, Industry, and Regulators
In March 2017 the European Medicines Agency (EMA) published a major revision of the guidance on RMPs: the Good Pharmacovigilance Practice (GVP) Module V Rev. 2 and the related RMP template. Five years of experience with GVP Module V, as well as the ongoing dialogue between stakeholders and Regulators, have been taken into consideration. The revised guidance aims to streamline RMPs, focusing on important risks and missing information (i.e., safety concerns) that have benefit-risk impact and require prospective planning or risk minimisation. It also provides guidance on how the safety concerns should evolve during the product’s life cycle to ensure a risk-proportionate approach. In parallel with GVP Module V Rev. 2, the EMA announced an upcoming revision of the guidance on PSURs (GVP Module VII) and published updated explanatory notes to GVP Module VII. The new RMP and PSUR will have different focuses and, likely, different lists of safety concerns, thus bringing new challenges to pharmacovigilance writing. The presentations and the panel discussion in this ESS session will explore the impact of the guidance revision on pharmacovigilance writing from different angles. A member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Pharmacovigilance Expert Committee, and an industry representative will present main aspects and practical challenges of the guidance revision and discuss how the guidance aims at better protecting patients´ health.
ObjectivesThe session will discuss the specifics of medical publications and regulatory requirements for rare disorders and orphan drug applications, and any other documents (e.g. patient management guidelines) relating to this field.
ContentCarl Bjartmar will start the session by reviewing the most important epidemiological, etiological and clinical aspects of orphan diseases, and also will discuss a number of topics such as developing a publication plan, communicating clinical trial data, writing manuscripts and regulatory writing. These topics will be illustrated by real-life examples to highlight the advanced requirements of medical writing for orphan diseases and drugs. For further details, read Carl’s abstract.
Elisa Ferrer will present the growing engagement of patients with rare diseases in the process of clinical development of orphan drugs. Medical writers who prepare regulatory documents need to understand the importance of bringing patients into the co-creation process or the review of regulatory or medical information documents. In this session, practical tips on how medical writers can involve patients in regulatory document development will be shared. For further details read Elisa’s abstract.
European Medicines Agency (EMA) is responsible for the scientific evaluation of marketing authorisation applications for all orphan medicines in the European Economic Area (EEA), as they fall under the mandatory scope of the centralised procedure. In the second part of this session, Dr. Elisabeth Penninga who is Chief Medical Officer at the Danish Medicines Agency, and a full member of the Committee for Orphan Medicinal Products (COMP) at EMA will describe the process of orphan designation and will provide an overview of what has been achieved in EU since the orphan legislation entered into force in 2000.
Medical writing for orphan diseases and drugs: Key considerations from a pharmaceutical company perspective (abstract, Carl Bjartmar)
The rarity of orphan diseases raises several important considerations in the partnership between medical writer and pharma colleagues. At initiation of the collaboration, writers are unlikely to have previous specific disease experience, although experience in a different orphan disease or a related disease area may be valuable. Therefore, this talk will review the most important epidemiological, etiological and clinical aspects of orphan diseases. It will provide the basic epidemiological definitions and data, focus on specific, common features of this group of diseases, and highlight etiological and clinical differences of orphan diseases compared with common disorders. Due to limited previous drug development, few documents may be available for guidance, either for regulatory writing or for publications for healthcare professionals (HCPs) or patients. When developing the publication plan, there is also often a need to raise awareness of the condition, as rare diseases are frequently under-diagnosed. Furthermore, common rare diseases complexities, e.g. involving complex genetics, must be clearly and consistently explained across publications. When communicating clinical trial data, the study design may need to be justified, e.g. small sample size, lack of a control arm. In addition, endpoints may need to be validated. For regulatory writing, a thorough understanding of marketing authorisation processes; regional differences in incentives; and the implications of potential fast-track designation are essential. At the manuscript stage, medical writers may need to advise on journal selection. General medical journals may be reluctant to publish on rare diseases and yet there are few specific journals on these conditions, and these have restricted readership. Of note, there is often a small author pool and individuals may be overburdened. Moreover, there may be limited expert peer reviewers with sufficient knowledge of the condition and available treatments. As the development of orphan drugs is particularly costly, medical writers should ensure cost-effective use of publication budgets. These considerations will be discussed and selected examples will be used to highlight the advanced requirements of medical writing for orphan diseases and drugs.
Enabling effective engagement of rare disease patients through meaningful documents (abstract, Elisa Ferrer)
The involvement of patients in medicines research and development allows researchers, medicine developers and regulators to better understand the medical condition, its impact on patients' lives and their priorities in terms of clinically meaningful therapies. These perspectives may differ from those of clinicians or the pharmaceutical industry. Patient engagement is particularly important in the field of rare diseases where scientific knowledge is scarce and treatment options are often non-existent or have low efficacy. Thus, patient-focused clinical trial design of orphan products may result in more relevant outcomes for patients, with an added benefit of reducing the uncertainty at the time of a medicine’s benefit-risk assessment. Rare disease patients are actively engaging at different levels with medicines developers, regulators and health technology assessment (HTA) bodies/payers. At the European Medicines Agency (EMA), patients participate in many activities including being full members of EMA scientific committees, ensuring that regulatory documents are understandable by the general public and also contributing their expertise in protocol assistance/scientific advice procedures. Rare disease patients are also central within the European Reference Networks ensuring the patient-centric approach in health care, research, ethical aspects and data sharing and protection. Complex medical language can be a barrier to effective patient engagement; health literacy is fundamental for a meaningful integration of the patients’ voice into the drug development process. Although capacity-building led by patient organisations increases patient understanding of the drug regulatory process, provision of clear, accurate and unbiased information in a patient-friendly format and language is also the responsibility of the institutions engaging with patients. Medical writers can contribute to successful rare disease patient engagement through the development of materials supporting these requirements from lay clinical trial summaries to scientific advice dossiers. Patient organisations encourage writers to bring patients into the co-creation process or review of regulatory or medical information documents. In this session, practical tips on how medical writers can involve patients in regulatory document development will be shared.
Friday 04 May
Expert Seminar Series
ContentIn 2016, the EU approved new harmonised privacy regulations, known as the General Data Protection Regulations (GDPR). The GDPR will impose greater obligations on companies established in the EU or who target or monitor European data subjects. Non-compliance with these regulations may incur penalties of up to 5% of a company’s annual worldwide revenue. The GDPR will become enforceable in May 2018; therefore, it is vital for businesses to start preparing now. This ESS will cover
· Goals and general principles of the GDPR
· Material and territorial scope of the GDPR
· New data subject rights under the GDPR
· Controller and processor obligations under the GDPR
· Consequences of non-compliance under the GDPR
· GDPR impact on clinical and regulatory document submissions and disclosure
· GDPR linkage to and overlaps with EMA Policy 0070.
ContentRegulators in the European Union (EU) and United States (USA) have developed legally binding frameworks for registration of new clinical trials and the reporting of summary results of completed trials in their respective publicly accessible registries (EudraCT and clinicaltrials.gov) within strictly defined timelines. Although synergies exist between public results posting activities and clinical trial report writing, there are differences in their approaches. Understanding the strategic mindset that underlies results posting will help medical writers to prepare smarter clinical-regulatory documents and understand how to utilise, harmonise, and repurpose such documents. Differences between the EU and USA registry mindsets and posting requirements will be highlighted. Other potential opportunities for aligning statistical/data management datasets and updating existing internal processes for regulatory document preparation will be explored to optimise reporting and trial disclosure efficiency. Specific examples will be shown using CORE Reference (www.core-reference.org) as a tool for preparing documents that support results postings in trial registries.
Publication of a plain language (lay person) summary of a clinical study in public databases is a requirement of the EU Regulation 536/2014. In this context, the implications of the plain language summary as a pre-publication and its effect on the peer review journal publication need to be considered. Furthermore, current standpoints of stakeholders, other than the legal bodies, that influence the public disclosure of clinical trial information will be presented and the role of medical writers during the preparation of regulatory, medical communication, and public disclosure documents highlighted.
Expert Seminar Series
ContentCochrane is a global independent network of researchers and people interested in health that gathers research evidence to support health decision-making using high-quality information. Cochrane’s main output is the Cochrane Database of Systematic Reviews (CDSR), a collection of systematic reviews of randomized controlled trials (RCTs) of health-care interventions and diagnostic tests. Systematic reviews - the gold standard source of evidence-based research – mostly focus on RCTs but can include other study designs, such as non-randomized studies. Some Cochrane Reviews such as “Neuraminidase inhibitors for preventing and treating influenza in adults and children” have drawn on data from Clinical Study Reports (CSRs).
Typically produced by drug manufacturers, CSRs provide detailed information about the planning, execution, and results of a clinical trial, and are used by government drug regulators to meet licensing and regulatory obligations to register a new drug. Bias is introduced on selective reporting of CSRs because until recently, they remain confidential documents; however, legacy CSRs and other regulatory documents are becoming increasingly available due to efforts of the Nordic Cochrane Centre, the BMJ and the European Ombudsman. Recent EU public disclosure requirements are now placing newer CSRs in the public domain.
RCTs suggesting a beneficial intervention effect or a larger effect size tend to be published more readily compared to similar trials showing negative results. In this context, a systematic review including only published studies could identify a false beneficial intervention effect, or miss an important adverse effect of an intervention. Currently, Cochrane is devoting a Methods Innovation Fund to determine the usefulness of using CSRs in a systematic review. Guidance will assist with identification of risk factor triggers that lead to reporting bias. CSRs may provide additional information on unreported outcomes, different time points or additional measurements even if the trial has been published in a journal.
ObjectivesThis session will discuss the skills needed for good medical journalism; present the training opportunities; review the sources of exciting information; indicate different professional paths; ethical aspects of journalism, and much more.
Brian Trench will explore what general media audiences expect or want from science and medicine news, how journalists’ criteria for selecting news have evolved and how these apply to medicine in particular. Brian will reflect on journalistic choices and on the implications of those choices, including the ethical dimensions. For further details, read Brian’s abstract.
Danny Buckland will host an interactive talk, analysing the mechanics of recognising a story, researching it and producing cogent editorial material. He will examine the necessary components to generate editorial and publishable content, and will share his secrets on how to create a template for building a story. The talk will be well illustrated with practical exercises. For further details, read Danny’s abstract.
The session will conclude with Sabine Louët focussing on technology changes that impact the way in which medical writers and journalists operate. Sabine will explore possible tips for future medical journalists, and will also discuss the many ways in which writers in medicine can save time by using tools that are readily available on the Internet. These include automatic transcription of audio to text, news monitoring web sites, news curation web sites, and collaborative working platforms. For further details, read Sabine’s abstract.
ContentWriting Science for News Media (abstract, Brian Trench)
Journalists writing about medicine and science have the same responsibilities to their audiences as journalists in other fields; they have to consider whether the story they want to tell is relevant and meaningful to their readers, listeners and viewers. They also have a wide range of possible ways to tell stories about research, which may or may not make such stories more appealing and interesting.
Writing for general news media requires journalists – including specialist journalists – to keep their publics in mind always. News about medicine of great relevance to professionals in the field may have little appeal or interest for wider audiences.
This talk explores what general media audiences expect or want from science and medicine news, and what attention they pay to such stories. It examines how journalists’ criteria for selecting news have evolved and how these apply to medicine and science in particular. It reflects on the mounting challenges of selecting news for fragmenting audiences.
There are many types of media story that may be used for reporting or analysing an item of news or issue in medical research. Journalists face hourly and daily choices about the types of story they tell. Research findings may be told as stories of breakthrough, of imminent promise of a cure, of warning about health risks, or in myriad other ways. This talk reflects on the prevalent choices of journalists and on the implications of those choices, including the ethical dimensions.
Decoding the Genetics of Journalism (abstract, Danny Buckland)
Journalism is experiencing a period of huge change with traditional media challenged by Internet content and society transitioning from print to online consumption. But, despite unprecedented upheaval, the mechanics of recognising a story, researching it and producing cogent editorial material remain constant.
This talk examines the components that are needed to generate editorial content that can be published. These building blocks are particularly important in health and medical journalism where there is great public interest that has been catalysed by both scientific advances and rising concerns about how healthcare systems are able to fund caring for an ageing public living with chronic conditions.
By understanding the core elements of a ‘story’, a journalist – novice or experienced – can create a template to apply to even the most complex and dense medical material.
Millions of people regularly try to diagnose themselves online and the hunger for relevant, accurate health stories is growing. Journalism has to change its mode of delivery but its vital signs can still provide a route to publication. Expect practical exercises.
From medical writing to medical journalism: How technology is changing the way medical writers and journalists operate (abstract, Sabine Louët)
Any medical writer interested in the world of medical journalism may benefit from the way web technologies can assist professional journalists.
The time is ripe as the Internet is making it easier than ever to find suitable sources of information. In this session, we will explore possible tips for future medical journalists, such as:
· How do we define medical news?
· Typical skills required to become a medical journalist
· Information sources (PubMed; ClinicalTrials repositories)
· Source selection criteria (which to trust and which to not)
· How to choose credible people to interview for third party commentaries
Technology is offering solutions that can make the work of medical journalists much more efficient. The session will discuss the many ways in which such professionals can save time using tools that are readily available on the Internet. Among others, we will discuss the following tools:
· Automatic transcription of audio to text
o Trint (won an Award at the GEN Summit 2016 in Vienna) or Voxalab or Happy Scribe
· News monitoring web sites: Ezyinsights, NewsWhip, etc.
o Set up RSS feeds to monitor your favourite news sources
o Some have free limited access that may be useful
o Some negotiate a reasonable fee for freelance writers
o Can complement your web site content or coverage
· News curation web site (Scoop.it, Paper.li)
o Helps gather information and background documentation necessary to draft journalistic pieces
· Collaborative working platform, e.g. SciencePOD
o People needing resource have direct access to a community of medical writers, editors, and proof-readers with selected expertise across the whole gamut of medical disciplines
Freelance medical writers can reduce the time spent on self-marketing. This returns control to writers to select whom they want to work with.