Pharmacovigilance and Risk Management Strategies 2016

You will hear from a member of the MHRA on initiatives to move beyond the implementation of the new pharmacovigilance legislation to enable the operation of the requirements to the highest possible standards against agreed standards and best practice - The SCOPE project, a three year EU-wide pharmacovigilance project, is being coordinated by the MHRA to help member states meet the requirements of the new pharmacovigilance legislation. The second presentation, given by an Industry representative, will look at the implications of the new CT regulations for PASS studies, both interventional and non-interventional. The final presentation will be a view from the EMA on regulatory pathways for Adaptive licensing, an increasingly important way to make medicines available quickly for life-threatening diseases where there is no currently available effective treatment.