Information obtained from medical and scientific literature is an important source of patient safety data and can contribute enormously to the safety profile of a medicinal product. It is a regulatory requirement for the marketing authorization holder (MAH) of a medicinal product to perform regular searches of the scientific literature, including any unpublished manuscripts and abstracts presented at medical or scientific conferences.
Within this whitepaper we will explore;
- The different types of literature searches
- Regulatory requirements
- Literature search strategy and how these should be constructed in such a way to ensure the optimum retrieval of the most appropriate articles
- The implications of inadequate literature searches
- When to start literature searches
- Examples of inspection findings