Expert Seminar Series

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.

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Wednesday 03 May

Content

Does involving medical writers raise the standard of publications and speed up the writing and publication process?
Several studies have suggested that medical writing support can ensure compliance with reporting guidelines, expedite publication and prevent misconduct. The most recent, an award-winning study comparing the quality and timeliness of peer-reviewed publications with and without medical writer support, was published in
BMJ Open in 2016.
In this session, we will critically evaluate the evidence supporting the contribution of medical writers to peer-reviewed publications. We will also explore other ways of determining the value of medical writing support and look at how we can disseminate the evidence demonstrating the value of the work we do: for example, the forthcoming position statement on the role of professional medical writers in scientific publications. This session will describe the development of the position statement and explain what it means for our profession.
10:15
to
10:30

Refreshment break
10:30
to
12:00

How to Deliver a Successful Medical Conference
Expert Seminar Series Session 1 Medical Communications

Content

Medical conferences form a central part of most communication plans. Many rely on significant input from medical writers in developing the programme, delivering a range of outputs, working with faculty, and project-managing the event.
In this session we will discuss:
· Different meeting formats, e.g. physical versus virtual conferencing, and their place in the communication plan
· Practical meeting organisation including: location, duration, selecting and managing speakers, producing outputs such as slides, the conference programme and newsletters, getting the contents continuing professionaldDevelopment (CPD)-accredited, adhering to guidelines on hospitality, and using gimmicks such as 3D presentations
· Telling the story: managing and delivering the message
· Is it possible to maximise learning impact, and how can we measure success?
· Financial considerations and practical tips
11:45
to
13:15

Lunch
13:30
to
15:00

Pharmacovigilance Documents – What Do Patients Really Want and Need?
Expert Seminar Series Session 2 Pharmacovigilance

Content

The move towards personalised medicine and involvement of patients in their healthcare decisions has led to major changes in pharmacovigilance (PV) legislation and more open discussion of clinical development. This session will discuss the challenges facing the pharmaceutical industry from the perspective of a global thought leader on writing for the lay audience, and the impact of new legislation from a regulatory authority perspective.
First we will discuss what patients really want and need from PV documents. A key document is the package leaflet, which in a more patient-centred world, would be entitled the ‘patient information leaflet’. User testing is effective, because it combines a quantitative element – can people find and understand key points? – with a qualitative element – what are their views and opinions on the document?
We will then discuss the Risk Management Plan guidance update and the impact of the new EU Regulation No.536/2014 which requires a summary of clinical trial results in lay language for public disclosure. It will be explained how and why the EMA supports the move towards increased transparency, and why writing information for the lay audience is important.
15:00
to
15:15

Refreshment break

Content

How Do We Tell Them? – Navigating Safety Issues - For Health Care Professionals and the Public

Emerging safety issues related to medicines pose a challenge when we need to communicate them. It is mostly new and incomplete information that cause the most problems: the causal relationship between medicine and suspected adverse reactions might not be established or the significance for the individual patient could be unclear. Furthermore, the implications and the consequences might differ between population and individual levels. Both health care professionals and the general public need clear and useful information in order to be able to make wise decisions on their treatments, and they increasingly expect information to also be timely and readily available. The uncertainty surrounding emerging safety issues stands in vivid contrast to the needs and expectations of the audience, and great care must be taken not to cause unnecessary anxiety, while still providing key information that is not only clear and concise, but also truthful and reliable.
While most of the information needs of health care providers and the public overlap, some specific aspects should to be considered: the individual patient’s or carer’s attention might focus on the implications at the individual level, while health care professionals or decision makers in public health will need more information on the implications at the population level. Also, if separate communications to professionals and the general public are required, good timing and coordination are essential. Next to the obvious information that should be provided on the medicine, how to use it, and potential adverse effects, some key points that must be addressed are: the degree of uncertainty (“
what do we know and what not”), the steps being taken to reduce the uncertainty, as well as what action health care professionals and patients are advised to take (or not) should also be provided.

Healthcare providers and patients - shared decision making in pharmacovigilance.

In future health-care systems, healthcare providers will have to engage in shared decision making with patients. EU Directive 2010/84/EU and EU Regulation 1235/2010 provide recommendations for patient centred implementation of pharmacovigilance; e.g. Directive 2010/84/EU specifies education errors and misuse as part of the definition of an adverse event (AE) and therefore means that they must be reported as such. The way to implement more patient focused pharmacovigilance will include the following steps: 1) Educate, 2) Encourage, 3) Engage, and 4) Enable patients. Education and encouraging covers training and informing consumers regarding AE-reporting systems. The role of social media in engaging patients and improving their awareness about a product safety and benefit-risk profile is growing. An important goal in informing patients is to reduce preventable AEs by producing a prescription label in a patient centered manner, e.g. by using appropriate label language, providing explicit text to describe dosing, improving label readability and including supplemental information. Finally, patient centricity in pharmacovigilance also involves listening and communicating to patients to enable them to participate in the assessment of the benefit and risk of a drug.

Friday 05 May

08:45
to
10:15

Responses to Authorities and the Role of the Medical Writer
Expert Seminar Series Session 3 Regulatory

Content

Medical writing support on a submission dossier does not end when the dossier goes out of the door to the authorities. Before submission, and during the dossier review process, the regulatory agencies generally do have questions to be answered by the sponsor. What role can a medical writer play in this process? How can we, as writers, help teams plan for, and efficiently prepare, answers to these questions? What is the difference in the process between the EMA centralised procedure and an FDA submission? This short seminar will provide answers to these questions and will highlight tools and tips for coordinating the activities involved. After the speaker presentations, there will be a Q&A session where participants can discuss their experiences and share ideas to optimise the process.
10:15
to
10:30

Refreshment break

Content

Surprisingly little formal guidance on the document structure for clinical study protocols (CSPs) has been available until recently. As a consequence, there is considerable variability across the community as to how CSPs are organised and structured.
Early in 2016, CSP templates were independently released by two authoritative sources, TransCelerate and the NIH–FDA. As the templates differ in several aspects, teams developing CSPs still must determine how best to structure their CSP documents.
Topics for consideration at this seminar include: purposes of the CSP; expectations of the diverse CSP target audience; advantages and disadvantages of standardisation in general; standardisation of content items versus standardisation of structure; and investigator expectations of good CSP structure.
This ESS strives to help teams who develop CSPs to make informed decisions on the structure of their CSP documents. Outside the scope of this ESS are all aspects of automation of CSP preparation and data flow (eProtocol).