Medical Writing in Pharmacovigilance
- Key terms and medical concepts
- Case narratives
- Risk management plans
- Periodic safety update reports
- Development safety update reports
- Writing skills and common errors
This two-day workshop provides an
introduction to medical writing for
pharmacovigilance, as well as insights
into several relevant safety documents.
Participants will learn regulatory require-
ments and how to apply guidelines to
prepare pharmacovigilance documents. In
addition, they will learn important aspects
of writing and interdisciplinary preparation
of pharmacovigilance documents through
practical exercises. Participants will also
learn about style and terminology for
pharmacovigilance documents (for regu-
latory, medical and lay public) and will
receive tips from experts' practical
experience.
This workshop will be held in German, but
since slides and exercises will be in English,
a good working knowledge of the English
language is required.
Termin
| Datum: | 08.07.2015 |
| Ort: | NH Heidelberg Bergheimer Str. 91 -69115 Heidelberg |
| Preis: | 1.590,00 EUR zzgl. MwSt. |
Zielgruppe
This workshop is intended for those who work in the pharmaceutical industry and need to prepare regulatory pharmacovigilance documents. Participants who are new to medical writing should have some basic knowledge of the drug development process, of regulatory documentation, and of pharmacovigilance. Participants who are knowledgeable in drug safety, who are occasionally involved in the preparation of regulatory documents and who wish to improve their skills, will also benefit from this workshop.
Kontaktinformationen
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