Medicines for Europe - 12th Pharmacovigilance Conference

The morning sessions will provide the opportunity for conference attendees to catch up on all recent activities and to prepare themselves for upcoming milestones such as:

• Data protection regulation and the impact on pharmacovigilance processes
• Finding out when the outcomes of measuring the impact of pharmacovigilance activities are expected and possible changes that might follow
• Better understanding the initiative on Patient Hearings with reflections from the generic and biosimilars point of view
• Changes in the signal detection process and what will happen after the pilot period ends
• Experience gained with the enhanced EudraVigilance, good practices and the way forward

Compliance and pharmacovigilance outside the pharmacovigilance department will be the centre of interest during the afternoon session. Examine the new trends for the digital era.

The Conference will conclude by reporting on the progress of the HaRP (risk management plan worksharing) project.

Over the years, one of the key successes of this conference has been the ability to secure the continuing support of key regulators. Sessions will once more be open and interactive giving attendees the opportunity to raise challenging issues in an informal environment.