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DDF20 – GCP Training for medical writers
Who it is for
This workshop is intended for writers with little Good Clinical Practice (GCP) experience whose work involves clinical trial documents e.g. informed consent forms, protocols and reports.
What it covers
The first part of the workshop will provide an overview of the principles of GCP, including the Declaration of Helsinki, the ICH E6 GCP Guideline, the EU Clinical Trial Regulation 536/2014 and ISO 14155:2020. The second part of the workshop will focus on how to ensure that documents are GCP-compliant, and the cross-checks that can be made, particularly when writing clinical study reports.
Raquel Billiones ( PhD in Biology) has been a regulatory MW for >20 years, covering both pharmaceuticals and medical devices. Her core competencies include clinical trials and submissions documents, data disclosure and protection, and project and people management. Over the years, she took on a wide range of industry positions, as freelancer, as employed regulatory writer, and as head of medical writing departments in the CRO and big pharma settings. She currently leads the MW pediatrics Immunology portfolio at Johnson & Johnson Innovative Medicine. Raquel is an active EMWA member since 2006, serving in various roles, is currently Editor-in-Chief of Medical Writing and member of the EMWA Executive Committee.
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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.