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DDA3 – Writing a Clinical Summary for a Regulatory Submission
Who it is for
This workshop is aimed at writers with experience in writing clinical study reports but who are new to writing CTD Clinical Summaries.
What it covers
The workshop will begin with a brief presentation on what the CTD
Clinical Summary is and where it fits in to the overall clinical dossier. This will then be followed by a review of the Clinical Summary structure and the important points within each section. This will then be followed by a review of some example data
packages and a group discussion will take place to decide the best way of presenting the data. Finally, there will be a review and summary of the key messages to bear
in mind when writing a CTD Clinical Summary.
Debbie has been working in the pharmaceutical industry for over 35 years in both pharmaceutical company and CRO environments. She has worked as a data assistant, CRA and project manager, before moving into medical writing. Twenty years ago she set up her own medical writing company and now works on all aspects of medical writing from clinical development programmes and regulatory packages through to marketing and conference material. Debbie also provides
training in medical writing and associated topics to a variety of organisations. Debbie has served on the Executive Committee of EMWA in the past and was a key member of the CORE reference working group.
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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.