Expert Seminar Series
The EMWA Expert Seminar Series (ESS) welcomes experienced medical writers, heads of medical writing departments, and industry leaders from other disciplines who are interested in the latest developments affecting the medical writing industry and playing a role in shaping the world of medical writing.
Wednesday 5 May
ESS 1 - Medical Writing – New Areas to be Explored
The regulatory ESS will provide food for thought with the new areas developed and developing in the pandemic era. We will discuss specific areas such as biosimilarity, and biosimilar-specific considerations in medical writing, and transparency, with a discussion of the steps necessary to transform source data to a fully anonymised and documented package, including assumptions and potential pitfalls. In addition, we will have a specific talk about the COVID-19 implications for regulatory medical writing augmenting the medical writer role, bringing added value, and protecting the integrity of the data which are communicated to regulators, prescribers, and consumers. The expert panel consists of speakers from the pharma industry and a statistical consultancy, and experienced medical writers.
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1:30 PM
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1:35 PM
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1:35 PM
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2:25 PM
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3:15 PM
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3:30 PM
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4:35 PM
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4:45 PM
Friday 7 May
ESS 2 - The EU Medical Device Regulations
The regulatory landscape in the medical device field has changed so much in the last few years. Game changers in the form of new regulations and guidelines have been released or about to be implemented. Is 2021 the year when the EU MD Regulation becomes fully applicable? How does the ISO14155:2020 impact clinical research? And finally, what is the role of medical writers in this complex environment? These are some of the questions that will be discussed in this session.
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9:00 AM
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9:10 AM
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10:00 AM
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10:50 AM
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10:50 AM
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11:05 AM
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11:05 AM
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11:55 AM
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11:55 AM
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12:30 PM
ESS 3 - Plain-language summaries (PLS) for peer-reviewed publications: evaluating their role, purpose and format
A plain-language summary for a medical research publication aims to summarize the results of an original research article in a way that makes the findings and recommendations readily understandable to patients, consumers of health care, and non-specialist healthcare professionals.
Some academic journals are now requesting submission of plain-language summaries, but very few are published. Problems cited include a reluctance by journal editors and authors of research articles to publish what they perceive as, replicating the article abstract or ‘dumbing down’ their findings.
A further challenge is that less than 50% of physicians surveyed recently said that they valued plain-language summaries, and other research indicates that patients prefer general web search engines and patient organisation sites over medical journals.
Clearly, there remains a gulf between the good intentions and then delivery of a fit-for-purpose communication. In this Expert Seminar we will thoroughly evaluate the role, purpose and format of plain-language summaries with active participation from all key stakeholders.
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1:30 PM
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1:35 PM
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2:05 PM
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2:35 PM
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3:05 PM
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3:25 PM
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3:25 PM
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3:55 PM
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3:55 PM
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4:25 PM
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4:25 PM
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4:45 PM