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Clinical trial disclosure & transparency
Who it is for
Open to EMWA members registered for the EMWA Autumn Conference 2026.
What it covers
Clinical trial transparency & disclosure – from requirements to practice
Clinical trial transparency requirements continue to evolve, making it increasingly important to understand what needs to be disclosed, when, and how.
This interactive workshop provides a practical overview of US and EU disclosure requirements, including FDAAA 801, the Final Rule (42 CFR Part 11), the EU Clinical Trials Regulation and CTIS. We will cover registration and results reporting, public disclosure of study information and documents, and approaches to PPD and CCI redaction.
Attention will be given to disclosure from a medical writing perspective: understanding transparency requirements for key study documents and preparing documents with future public disclosure in mind.
Edith is a clinical trial transparency and disclosure expert with extensive expertise in trial registration and registry maintenance. Highly organised and solution-oriented, she brings structure to complex registration processes and ensures that trial data is shared responsibly, clearly, and in alignment with internationals standards and guidelines.
Edith is Associate Director, Data Transparency and Medical Writing, and Principal Disclosure Manager at Staburo with over 20 years of experience in clinical research.
Ulrike combines expertise in clinical trial transparency and disclosure and medical writing with programming. She enjoys connecting these different perspectives and turning complex requirements into practical solutions and has a particular interest in the disclosure of estimands on global clinical trial registries.
Ulrike is a Senior Disclosure Manager and Medical Writer at Staburo with more than 10 years of experience in clinical research.
Maarten is a clinical trial transparency and disclosure expert specialising in results disclosure and Policy 0070. His calm, pragmatic approach helps keep complex projects moving even under tight timelines.
Maarten is Associate Director, Data Transparency and Medical Writing, and Principal Disclosure Manager at Staburo with over 30 publications and over 8 years of experience as academic researcher.
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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.