Artificial Intelligence Steps into Drug Safety Surveillance, Yet falls Short in Certain Key Aspects
In the latest episode of Denatured, a podcast that delves into drug discovery, data, artificial intelligence, policy, regulatory issues, and Europe, Lori Ellis, the Head of Insights at BioSpace, and Ana Pedro Jesuíno, the Global Head of the Local QPPV Network at IQVIA, discussed the transformative impact of AI on pharmacovigilance on a global scale, with a specific focus on the role of local qualified persons for pharmacovigilance in the EU.
The episode, presented in partnership with IQVIA, highlighted the primary responsibility of the EU Qualified Person for Pharmacovigilance (EU QPPV), who oversees pharmacovigilance activities in the EU. The EU QPPV is tasked with establishing and maintaining a pharmacovigilance system, monitoring the safety of authorized medicinal products, ensuring compliance with EU regulations, and serving as a point of contact for competent authorities.
In addition to the EU QPPV, many European countries require a Local Person for Pharmacovigilance (LPPV). The role of the LPPV, subject to national legislation, includes responsibilities such as reporting to the EU QPPV and ensuring compliance with local pharmacovigilance requirements.
The discussion on Denatured focused on the evolving role of LPPVs, with increased emphasis on compliance with local regulations, enhanced safety monitoring, and global coordination becoming increasingly important as global regulations become more complex and as more products are marketed globally.
Lori Ellis, whose current focus is on the impact of technology on the pharmaceutical industry, can be reached at lori.ellis@our website, and she can also be followed on LinkedIn. For more specific insights into the evolving role of LPPVs as discussed in the podcast, direct access to the podcast content would be necessary.
The episode can be listened to on various platforms, including Spotify, Apple Podcasts, Amazon Music, and iheart. Lori Ellis analyzes and comments on industry trends for BioSpace and clients.
Denatured is a valuable resource for anyone interested in staying informed about the latest developments in the pharmaceutical industry, and this latest episode provides valuable insights into the evolving role of local qualified persons for pharmacovigilance in the EU.
The Denatured podcast, focusing on drug development, delves into the incorporation of artificial intelligence in pharmacovigilance, illustrating its transformative role in health-and-wellness, science, and medical-conditions, especially within the European Union. Lori Ellis, an expert in the impact of technology on the pharmaceutical industry, emphasizes the growing significance of local qualified persons for pharmacovigilance in the context of technology and health-and-wellness. This emphasized the importance of technology in drug development, particularly the role of AI, and how it impacts medical-conditions and the pharmaceutical industry.
