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DDF33 +34b Clinical Study Reports – Mastering the Essentials Skills (Double Workshop)
Who it is for
This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).
What it covers
This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the
production of CSRs.
The course will cover:
• CSR project preparation and timelines
• Writing a CSR according to International Conference on Harmonisation (ICH) E3 guidelines and CORE reference
• Writing the methods sections: brief overview and advice
• Interpreting data, describing results: demography and baseline characteristics
• Interpreting data, describing results: efficacy; using the statistical report
• Interpreting data, describing results: safety and safety narratives
• Different types of CSRs: abbreviated CSR, full CSR, post-marketing reports, medical device reports
• CSR review and quality control
• Appendices: an overview
Arine is a senior medical writer at Veristat. She has a PhD in sports sciences and has worked in academic research. She has been a medical writer since 2021 and is experienced at writing a wide range of regulatory documents on pharmaceuticals and medical devices, covering various therapeutic areas. Arine has also mentored medical writers on several types of documents.
Gaele is a Medical Writing Manager at Veristat. She worked in academic research for 10 years, in France, the UK, Australia and the US, with a specific interest in rheumatology, paediatrics, medical imaging and sport sciences. Gaele has a doctoral degree in physiology and published approximately 30 scientific articles during her research career. She has been a medical writer since 2011 and is experienced at writing a wide range of regulatory documents and medical communications covering various therapeutic areas.
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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.