Medical Writing in Pharmacovigilance

This online workshop consists of two one-day modules and provides both an introduction to medical writing for pharmacovigilance and insights into several related safety documents. It will familiarise you with the relevant regulatory requirements and how to apply the guidelines when preparing pharmacovigilance documents.
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You will learn the important aspects of writing and the interdisciplinary preparation of pharmacovigilance documents through practical exercises. You will also learn about style and terminology for pharmacovigilance regulatory documents and receive practical tips from the expert.
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After the first day, you will have enough time to explore the various topics alone and apply all you have learnt. Any questions that arise can then be discussed and clarified with the speaker and the other participants on the second day.

Themen

- Key pharmacovigilance definitions and concepts
- English for technical documents
- Development & Periodic safety update reports: requirements, structure, content
- Introduction to the Risk Management Plan (RMP)
- Practical exercises
- Common pitfalls