Medical Writing in Pharmacovigilance

This two-day workshop provides an intro-
duction to medical writing for pharmaco-
vigilance, as well as insights into several
relevant safety documents. You will learn regulatory requirements and how to apply guidelines to prepare pharmacovigilance documents.
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In addition, you will learn important
aspects of writing and interdisciplinary
preparation of pharmacovigilance docu-
ments through practical exercises. You will
also learn about style and terminology for
pharmacovigilance documents (for regula-
tory, medical and lay public) and will receive
tips from experts' practical experience.
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The course will be held in English, never-
theless it will also be possible to pose
questions in German.

Themen

- Key pharmacovigilance definitions and concepts
- Scientific, technical or lay language
- Risk management plan: Contents, structure & requirements
- Development & Periodic safety update reports: Practical exercises
- Common pitfalls