Current Edition

Improving Transparency and Benefit/Risk Assessments with the New Risk Management Plan

There is no doubt that the future of drug development lies in personalised healthcare – making sure the right medicine is given to the right patient at the correct time and dose. The rapidly expanding fields of pharmacogenomics and more recently metabolomics are testament to this trend. However, for personalised healthcare to be effective, patients also have to be engaged and involved in the process. Both the regulatory authorities and the industry as a whole have recognised this and the process of drug development and treatment paradigms are changing as a result.  Julia Forjanic Klapproth & Lisa Chamberlain James of Trilogy Writing & Consulting discusses the recent raft of changes in PV legislation…pdf