The Department of Health Sciences of the University of Nicosia invites you to a lecture on the “Upcoming EU regulatory updates in the pharmaceutical sector” on Thursday, 8 May 2025, between 16:00-17:30 at the Grey Amphitheater, University of Nicosia.  

The European commission is set to update Regulation EU No 520/2012 relating to pharmacovigilance (“PV”) requirements for human medicines marketed in the EU, and the lecture will cover the most important aspects of these changes.  Overall, the upcoming EU regulatory updates will strengthen oversight of outsourced pharmacovigilance, mandate the registration of post-authorization safety studies in the EMA’s electronic register, and expand signal detection to include suspected adverse reactions, enhancing transparency, compliance, and patient safety. The proposed changes aim to harmonize the performance of PV activities by marketing authorization holders (“MAHs”), national competent authorities and the European Medicines Agency (“EMA”), and in some cases widen the scope of the Implementing Regulation’s PV requirements.  

Key points to be addressed: 

• Enhanced Oversight of Outsourced Pharmacovigilance Activities:
  Marketing Authorization Holders (MAHs) must establish clear contractual obligations, data sharing protocols, and audit rights when delegating safety-related tasks to third parties. 
• Mandatory Registration of Post-Authorization Safety Studies: 
  All safety studies must be recorded in the EMA’s electronic register, ensuring transparency and improved access to critical pharmacovigilance data. 
• Extended Signal Detection Requirements:
  Pharmacovigilance monitoring now includes suspected adverse reactions, reinforcing proactive risk management and patient safety measures.

Speaker:
Dr Dimitris Zampatis
Director Product Patient Safety
Sandoz International GmbH 

For more information, please contact Prof Lefteris Zacharia (E: [email protected]).