Preparation of Safety Documents
Preparation of safety documents is often challenging and the authoring team’s understanding of pharmacovigilance principles, relevant guidelines and the report preparation process is integral to creation of high-quality documents.
We therefore provide a suite of training modules on the following key safety documents for integration into your company’s staff training programmes.
The modules offer real-life, in‑depth training on how to actually write these documents, to complement your Standard Operating Procedures and Working Instructions:
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs)
- Risk Management Plans (RMPs)
Each module of the suite contains an overview of the document itself, including its purpose and how it achieves this, along with a ‘how-to’ guide on writing each section. A narrator adds detail to the information displayed and quizzes are included through the modules for assessment of learning.