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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
There is an increasing demand for transparency in clinical trials. This interest in transparency is not only demanded by the public but also by global regulators like FDA (US) and EMA (EU), with the overall aim being to make as much clinical trial information public.
For study managers in smaller companies and in academia it can be hard to keep up with this constantly evolving landscape of regulations. Additionally, the scope of required information, the increased demand for disclosure of documents, and actual data entry into platforms is often challenging.
This interactive workshop is designed to bring you up to date with the currently applicable regulations. We will have group sessions to practice protocol and results data entry into the platforms and will give advice on handling timelines and necessary record updates. Following this workshop, you will be confident in disclosing your studies in full compliance with applicable regulations and your own transparency goals.
Topics
· Regulations in the US: FDAAA 801 and the Final Rule
· Regulations in the EU: CT Regulation 536/2014 (CTIS)
· Designing a ‘disclosure ready’ study
· Practical training on data entry into Clinicaltrials.gov and CTIS
· Document disclosure (redaction of PPD and CCI, deferral)
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Booking is for EMWA members
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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.