April 20, 2015: pvnet, pvconnect, and labelnet working groups kick off: During the week of April 27th the Navitas Life Sciences networks launched 6 working groups to explore and build best practice around the latest industry hot topics attracting 100+ industry professionals. The pvnet, pvconnect and labelnet working groups for 2015/6 include:
- Benefit-Risk communications – strategies to ensure the latest benefit-risk information reaches patients and other intended stakeholders, at the right time, with the right media
- PV data futures – how to make sense of the deluge of data to protect patients through predictive Pharmacovigilance
- PV inspection management – a forum for industry to share insights and build new models to ensure PV system inspection readiness - for current and emerging regulations.
- Label content management – building best practices in processes, governance and organisation to drive consistent labelling content and timely implementation across regions to deliver global compliance and achieve operational efficiency
- Device and combination products – building best practices for the creation and management of Instructions for Use (IFU) and labeling for Medical Devices, Combination Products, and Software Applications classified as devices (Apps), integrating Human Factor considerations and requirements from the device and combination product development process.
- Tracking and technology – debating the needs and developing industry requirements for state of the art label management technologies
cmonet meeting update: On April 16th 2015 CMOs from a range of large and medium sized pharma companies gathered to discuss top of mind issues, topics included
- How to use real world data to support business objectives and effective benefit risk analysis
- Managing PSPs – how to derive value from ever increasing amounts of patient data
- 15 companies completed the CMO Survey in February 2015, the results were explored and the further evolution of the CMO role discussed