Session 1: Pharmacovigilance legislation: what are the next steps? Reflections from the Commission, European Medicines Agency and the Industry.
- The 3-year Commission report and Impact assessment, led by the EMA
- Scanning the horizon: what are the milestones ahead of us?
- Social media and technology supporting patient safety: opportunities and pitfalls
Session 2: Enhanced EudraVigilance & Signal Detection – how to prepare for the upcoming milestones? Reflections of the regulators and the industry perspective.
- EudraVigilance stakeholder change management
- How can companies ensure smooth implementation? – case study
- Overview of the new process for Signal Detection and Management
Session 3: Mini Workshops: how to improve pharmacovigilance activities?
- Educational material – is there a more efficient way to educate?
- Medical literature monitoring – service improvements after one year implementation
- Pharmacovigilance inspections and compliance – is there a more efficient way when companies are auditing each other?
- Signal detection – what and how to implement the changes?
- Pharmacovigilance of Biologicals – implementation of GVP P.II recommendations
All sessions will be followed by a panel discussion and interaction with the floor.
PROGRAMME 2017 NOW AVAILABLE