Safety monitoring research needs

Clearly, therefore, those involved in drug safety monitoring need to liase closely with both clinical research and medical information scientists. In addition, those responsible for clinical drug safety must undertake periodic safety update reports (PSURs) at predetermined intervals, in accordance with current International Conference on Harmonisation (ICH) guidelines. Such routine analyses can identify new safety signals as soon as they become detectable. 

Future development of affinity biosensors based on spectroscopy of guided waves will be driven by the needs of the consumer. These biosensor technologies hold potential to benefit important fields including pharmaceutical research, medical diagnostics, environmental monitoring, food safety, and security. Applications in these areas will challenge research and development in the field. 

It is imperative that they continue to regulate, evaluate, and monitor the safety, efficacy, and quality of new medicines entering the European market. In addition, the EMEA must stimulate innovation and research in the pharmaceutical sector so that the sector continues to grow and meet the needs of the populace. Also, the regulatory task becomes more important as migration within the community increases. 

There are many reasons why quality measurements are needed. Products must be tested for compliance and content, for safety, and to meet a variety of regulations. Quality measurements are also needed to monitor quality during production and in process control. Contracts are written based on standards and terms of procurement that must be tested. Every day, regulatory agencies make decisions based on results which are only as good as the quality of the methods upon which they themselves are based. Quality measurements support international and national trade and support research. Laboratories need to generate credible data and to do so they must have valid methods. 

---