The Medicines for Europe annual Pharmacovigilance Conference is a unique event where a broad range of stakeholders congregate to work together towards a common goal: to support access for EU citizens to safe medicines with an effective pharmacovigilance policy.
The 11th Pharmacovigilance Conference will once more see leading experts and regulators discussing the future direction of EU pharmacovigilance.
The opening session will review experience gained in the implementation of the legislation and will focus on current developments. The attendees will have an opportunity to learn about upcoming milestones and how to successfully prepare for them. The possible impact of Brexit – on the day-to-day work, processes and especially on responsibilities – will be discussed.
Compliance and inspections will be the centre of interest in our second session – how to keep up with recent developments and handle challenges, substantiated with case studies.
The traditional afternoon workshops will again stimulate lively and engaging discussions. Hot topics will be debated to identify the best possible processes and tools. Attendees will be able to choose from the following :
- Enhanced EudraVigilance and Signal Detection: first experience, implementation of the new process.
- Management of product information: how to secure the most up-to-date communication externally (regulators/HCPs/patients) and internally (PHV-regulatory-marketing department).
- The three ‘big ticket’ regulatory procedures – safety referrals, periodic benefit risk evaluation reports and risk management plans: focus on refined and efficient processes.
- Stand-alone IT session: use of telematics tools to support business needs in the simplification of regulatory processes.
All sessions will be followed by a panel discussion and interaction with the floor.