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DDA35 – Safety and Contraception information for the informed Consent
Who it is for
This workshop is ideal for medical writers with experience in creating documents for regulatory or non-specialist readers. It is especially beneficial for medical writers involved in developing informed consent materials for potential study participants. Medical writers who may need to produce written information in lay language about the safety and contraceptive aspects of a drug in clinical research will find this workshop particularly useful. Ideally participants understand an investigator brochure and a clinical trial protocol.
What it covers
The purpose of the Informed Consent Form (ICF) is to provide potential study participants with a clear summary of the risks involved in the study. This information should be written in easy-to-understand language so that participants can make an informed decision whether to participate in a clinical trial. It is essential for project and trial teams in clinical research to regularly update this information. Medical writers with expertise in regulatory and lay language writing can contribute valuable skills in developing and updating the risk information. The goal of this workshop is to help participants gain a comprehensive understanding of the language, templates, processes, and tools needed to effectively develop and update safety and contraception information in lay language for informed consent purposes.
The safety and contraception content in an ICF will be presented and discussed. There will be particular emphasis on the development of reproducible and harmonized side effect and contraception information. Other topics include recommended lay language terminology, tools, and process considerations.
Julia is an experienced medical writer with over 25 years of experience in academia. She recently joined Boehringer Ingelheim in July 2022 as an Associate Director of
Lay Language & New Media. Julia specializes in writing regulatory documents in lay language, including Brief Summaries of Clinical Trial Protocols, Lay Protocol
Synopses, and Lay Summaries of Clinical Trial Reports. She has also coordinated the development of the ICF Safety Section template and processes for development of the Safety Section of the ICF. Julia's expertise extends to data science, as she holds a certificate from MIT and is currently working on a project to automate certain aspects of medical writing using Artificial Intelligence. Julia is a member of the
American Medical Writers Association and member of the MidAmerica Medical Writers leadership team serving as the coordinator of Iowa Medical Writers networking events.
Cornelia Weiss-Haljiti is an Expert Medical Writer and a biochemist by training with a PhD in endothelial cell biology. For 10 years, she worked as a scientist leading
projects and laboratories in academia, biotech, and pharmaceutical industry.
Cornelia developed expertise in the discovery and validation of targets, drugs, and biomarkers.
In 2012, Cornelia joined Boehringer Ingelheim Pharma GmbH & Co. KG. to become a Medical Writer. She wrote regulatory documents across all phases and therapeutic areas. She holds the EMWA foundation and advanced certificate. Over time she
became particularly interested in plain language writing, graphics, and design. She
was the design lead of a digital platform to share lay summaries of study results with the public. Currently she leads and represents Informed Consent activities by the Lay Language & New Media Team, a specialized medical writing team within Boehringer Ingelheim.
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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.