Life sciences companies confront increasingly stringent requirements on safety signal detection and risk management. Regulatory authorities are taking steps to further safeguard patients by requiring companies to take more comprehensive steps to assess and monitor the benefit-risk balance of their products.

EMA SPOR Working group release the details to the SPOR ...

Our first blog on this topic addressed “The importance of mobility and medical affairs (MA) and its value to the organization is most definitely on the rise.” In this concluding blog we share specific examples of how mobile technology improves MA and arms you with the criteria and questions to ask as you investigate possible medical information solutions.

For many companies, signal detection in drug safety pharmacovigilance ranks closely behind regulatory submissions and case management as a key activity because it helps to proactively monitor a product’s risks that come to light from tracking the data submitted to internal and external drug safety databases and platforms.