2016 will be a very challenging year for all people dealing with safety of drugs, biologics and devices.
Further to the EMA-projects we have to consider that compliance with regulatory guidance becomes much more complicated and pragmatic approaches are key.
The PhVDay 2016 will provide solutions on how to handle with medication errors, MLM, E2B updates, inspection readiness, and risk management. The key for every PV-system is the adequate interaction between Regulatory Affairs and Pharmacovigilance. Further perspectives of product safety will be addressed for NCEs, Biologics and Medical Devices and the responsibilities cleared for the MAH and legal functions like EU-QPPV and local PV contact persons.