What is a patient risk management plan?
We develop patient risk management plans for our medicines to help us identify and reduce risks to patients and, where appropriate, we provide these to the regulatory authorities as part of our submission for approval to market a new medicine. Each plan has three parts: • Safety specification – information on all known risks and side effects associated with the medicine. This includes potential side effects where more research is needed to establish or refute a link to the product. We also highlight missing information – for example the medicine may not have been studied in certain patient groups such as children or women of child-bearing age. • Pharmacovigilance plan – the activities we are going to undertake to confirm or refute potential risks or to fill in missing information, For example, plans to carry out further research studies. • Risk minimisation activities – all plans include routine risk management activities such as product labelling and safety monitoring. For some medici
