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 the 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:
- Signal management – embracing the changes. Industry-focused session. The revised GVP IX. Familiarizing with the new signal detection process and how to prepare for the next steps.
- Management of Reference safety information: how to keep-up with the complex life-cycle of safety changes. Detection of changes, submission and approval process, implementation and dissemination to end stakeholders. Staying compliant within challenging timeframe. Invited: CMDh representatives and PV inspectors.
- Risk Minimisation Measures – reaching the target audience? Dissemination of RMMs – what works and what does not. Good practice examples. How to build on them. Invited: HCP representative.
- Communication in pharmacovigilance. How to communicate complex messages and content. How to engage with patients, educate and empower them. How to deal with the trust issue. Invited: Patient representative and Journalist.
Stand-alone IT session: Use of telematics tools to support business needs in the simplification of regulatory processes. Reflection on which data are strategic asset. Additional hands-on session on upcoming milestones & how to prepare.