Continuing Education Credits are not available for on demand offerings
Broadcast time: 1 hour 24 minutes

As of 2 July 2012, nearly all Marketing Authorization Holders faced the challenge of complying with new EMA regulations for safety signal tracking as described in GVP Module IX. Two large biopharmaceutical companies independently evaluated available technology for EMA-regulation--compliant safety-signal tracking systems. Both companies selected platforms with the flexibility to be designed utilizing a Business Process Management (BPM) framework. This webinar will provide an overview of GVP Module IX Signal management requirements, describe how to successfully meet the EMA mandate by presenting two case studies of developing systems to meet the requirements, and provide guidance for other biopharmaceutical companies facing a similar challenge.