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MCA7a – Writing Lay Language Summaries of Study Results according to EU Regulation
Who it is for
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.
What it covers
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, GLSP (Good Lay Summary Practice Initiative [EudraLex 10]) will be introduced and briefly discussed. The content requirements for lay summaries will be introduced and different approaches will be presented discussed. The basics of plain language writing will be covered along with relevant guidance documents (GLSP, ISO Norm on Plain Language 24495). Also, the appropriate use of graphics and pictograms will be presented and discussed. Participants will be asked to write a short paragraph of a lay summary based on a clinical document. In addition, methods for patient involvement in writing and review of lay summaries will be highlighted. Furthermore, translation of lay summaries and the various distribution options will be presented and discussed. We will also look at the latest developments in the field of lay summaries and similar documents such as the Lay Protocol Synopsis.
Julia A Hild is a Senior Medical Writer at Boehringer Ingelheim with a background in pharmaceutical biology and biological sciences. She holds a doctoral degree in human biology and a degree in plain language writing. Since joining Boehringer Ingelheim in 2020, Julia has played a pivotal role in developing lay language documents across multiple therapeutic areas. She specializes in creating patient-friendly materials, including lay summaries, lay protocol synopses, and informed consent forms. Julia also works with visual media, creating scripts and storyboards for videos and comics to support patient understanding. She established processes in close collaboration with the Patient Engagement team to involve patients in the review of lay language documents, ensuring their feedback drives clarity, relevance, and truly patient-centric communication.
Thomas M Schindler studied biology and linguistics in Germany and the UK, obtained a PhD in molecular physiology, and did postdoctoral research in the UK. Thereafter, he became an editor of popular science books in biology, geography, and astronomy. He then turned to medical writing and has meanwhile gained some 30 years of experience in both medical communication and regulatory medical writing focussing on the preparation of clinical documents needed for marketing authorization applications in all relevant geographies across therapeutic areas. He founded and established the medical writing function at Boehringer Ingelheim Pharma and headed the Innovation Medical Writing Group focussing on lay communication, good graphics development, video creation and AI-driven writing at Boehringer Ingelheim Pharma. He was a member of the TransCelerate “Return of Results” work stream, is contributing to the Good Lay Summary Practice initiative and was co-author on PFMD Plain Language Summary guidance for scientific articles. Thereafter, he assumed the role of Director Global Regulatory Affairs in BioNTech serving as CTIS (Clinical Trial Information System) Lead supporting all aspects of clinical trial authorizations in EU and EEA. He has lately started his own consultancy “RSW – RegulatoryScienceWriting” providing support on medical writing and regulatory topics.
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Registration fee first
The conference registration fee (€50) must be in your basket before any session can be added. It is one off and covers the opening session and the plenary.
Terms and conditions
Changes to registration
Changes may be made to workshop or seminar choices after booking (that is, a cancellation of one workshop or seminar choice and replacement by another), for an administrative fee of €27, plus any difference in price between the choice of workshops or seminars. Workshops, seminars and lunchtime sponsored sessions may be added to your original registration (subject to availability) at any time, without an administrative fee by contacting info@emwa.org. All changes are subject to availability.
Cancellation of attendance
If you wish to cancel your attendance at the conference, a refund, minus an administration fee of €162, will be made provided your cancellation is made in writing to EMWA head office before 20 October 2026. No refunds will be made after this date.
Payments
Invoices must be settled by bank transfer in Euro, or paid by card through Stripe. All fees are payable in advance. Full payment is due by 30 October 2026. If payment has not been received, EMWA reserves the right to request payment and cancel registration.