Setting up Signal Management is one of the first and important processes that need be set up in a pharmaceutical company testing or marketing a medicinal product.
You need to have a clear process description, standard operating procedure, which cover safety signals wherever they may come from; studies, market, literature, authorities, media etc and the procedure must describe how to scientifically assess if any of these signals, adverse event, are potentially related to the use of the medicinal product.
It a possible relation between the product and the adverse event is identified the procedure takes you through all the steps related to identifying how big the risk is and how to mitigate the risk. Does it require update to the product information, SmPC, IB, Protocol etc, is a trial stop needed, is a market withdrawal required, must agencies be informed – and how soon. All these questions must be answered and documented quickly when a signal is first identified. The Signal Management Suite of documents help you get ready through proper procedures, governance structure and documentation and it helps you get ready for inspection by regulatory agencies.
The Signal Management Suite include the following documents, templates, forms and presentations with guides and examples:
- Signal Management SOP (template) (word)
- Signal strategy (form) (word)
- Signal triage (form) (word)
- Signal assessment (form) (word)