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DDF30 Writing Risk Management Plans
Who it is for
Aimed at medical writers with little or no experience of writing risk management plans (RMPs), but with a basic knowledge of the overall drug
development process and some experience in assessing and presenting non-clinical and clinical data on drug safety and risks. Ideally, participants with no knowledge in pharmacovigilance should attend the foundation workshop on pharmacovigilance writing (DDF32) prior to register to this workshop. Writers with more experience of RMPs should consider EMWA’s advanced workshop on the topic, DDA20.
What it covers
This workshop will provide an overview of the preparation of RMPs according to Good Pharmacovigilance Practice (GVP). Participants will learn where to find relevant guidance and which source documents should be used while preparing RMPs within multidisciplinary teams. The most relevant drug safety concepts for RMPs (e.g. important identified and potential risk) will be explained, then the structure and content of the RMP will be presented and selected issues will be explored in exercises. Emphasis will be given to the focus, content, and data presentation of different RMP sections.
Principal Global Pharmacovigilance Writer – Boehringer Ingelheim Pharma
Tiziana has been specialising in pharmacovigilance writing since 2008 and has gained extensive hands-on experience with pharmacovigilance documents and health authorities’ assessments. She has developed broad expertise with the implementation of the GVP guideline related to RMPs and PSURs, and with the
evolving concept of safety concerns. In her current position at Boehringer Ingelheim, she is responsible for the coordination and preparation of lifecycle pharmacovigilance documents with a focus on DSURs, RMPs, and PSURs; in addition, she is involved in pre- and post-submission activities related to the global strategic planning and
health authorities’ assessment reports.
Tiziana provides trainings on pharmacovigilance writing for professional education institutions Europe-wide, including EMWA. She is an active volunteer for EMWA, where she was Vice President/President in 2017-2019; she has been chairing the
Pharmacovigilance Special Interest Group (SIG) since 2017, and since May 2021 she has been on the Committee of the Communicating with the Public SIG.
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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.