Browse and fill a basket without an account. You must sign in as a member before you can check out.
DDA32 – Writing Development Safety Update Reports
Who it is for
This workshop is for medical writers who would like to obtain knowledge about the Development Safety Update Report (DSUR). Participants should have some experience of collection and analysis of safety data, and an understanding of safety monitoring during clinical trials. Participants without this knowledge or without experience in safety/pharmacovigilance writing should in advance attend the course DDF32.
What it covers
Since 2011, DSURs are required in the ICH region for all marketed drugs or drugs under development for which clinical trials are ongoing. The aim of this workshop is to explain what the DSUR is, when it needs to be written (and when possibly not), which data and information need to be included and how to present them. It also provides guidance on the writing and project management process, taking into account that the DSUR is a document that requires an interdisciplinary and well-organised team effort within challenging timelines. Concise as per guidance, with a clear and logical structure, the DSUR nevertheless has some pitfalls in store that are also discussed in this workshop. To bring life and colour to the theory, all of this is illustrated with examples from the daily practice of preparing and writing DSURs.
Stefanie has been working in the pharmaceutical industry for many years, starting in biotech, moving on to marketing/sales, until she specialised in safety writing from 2011 onwards. She has extensive hands-on experience on DSUR, RMP, AddCO, and PBRER writing and currently works as a principal pharmacovigilance writer at
Boehringer Ingelheim. Stefanie joined EMWA in 2011 and has offered various workshops on safety writing at EMWA over the past years.
Sign in to check out
You can browse and fill a basket without an account. Sign in here to complete checkout — you stay on this page.
Reset your password
We will email a reset link. This page stays open.
Booking is for EMWA members
You are signed in, but this account does not have an active membership. You can keep browsing. Join EMWA to book — we will not send you away automatically.
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.