Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
The European Parliament and the Council of the European Union have reached political agreement on the reform of the EU pharmaceutical legislation on 11 December 2025.
The 24th Annual Meeting of the ISoP was held during 24–27 October 2025 in Cairo, Egypt, and was co-hosted by the Egyptian Chapter of ISoP. The event brought together over 500 participants from more than 80 countries across North America, Europe, Africa, Asia, Latin America (LATAM), and Oceania.
Artificial Intelligence (AI) is fast evolving and is rapidly transforming the development and supervision of medicines. The EU AI Act entered into force in 2024 and represents a significant step towards ensuring that AI is developed and used in a trustworthy, transparent and ethical way, while encouraging its uptake and creating a supportive environment for innovation. In 2025, it moved from adoption to practical application.
And much more...
The MHRA has identified examples of information relating to inspection activity submitted to compliance teams which have been generated by Artificial Intelligence (AI). This blog describes our current thinking in relation to the use of AI when generating information to support inspections.
The European Parliament and the Council of the European Union have reached political agreement on the reform of the EU pharmaceutical legislation on 11 December 2025.
The International Society of Pharmacovigilance (ISoP) is a global, scientific, non-profit organization dedicated to advancing pharmacovigilance (PV) and promoting the safe and appropriate use of medicines and devices
Artificial Intelligence (AI) is fast evolving and is rapidly transforming the development and supervision of medicines. The EU AI Act entered into force in 2024 and represents a significant step towards ensuring that AI is developed and used in a trustworthy, transparent and ethical way, while encouraging its uptake and creating a supportive environment for innovation. In 2025, it moved from adoption to practical application.
Pharma is employing AI to support approval submissions by predicting how regulators will react before data is submitted.
Drug safety assessment, particularly in the post-marketing setting, is especially vulnerable to analytic misjudgment because it relies on heterogeneous evidence streams, incomplete data, infrequent events, and decisions made under substantial uncertainty.
The 24th Annual Meeting of the ISoP was held during 24–27 October 2025 in Cairo, Egypt, and was co-hosted by the Egyptian Chapter of ISoP. The event brought together over 500 participants from more than 80 countries across North America, Europe, Africa, Asia, Latin America (LATAM), and Oceania.
More than 25 years after To Err is Human1, progress on patient safety remains too slow, still reactive, and fragmented.2 Despite advances in technical solutions, focus on safety cultures, and implementation of high reliability organizational principles, harm persists. Office of Inspector General data found that 25% of Medicare admissions involved adverse events, with fewer than 14% voluntarily reported.
A conversation with Kayak cofounder Paul English on how better meetings can become a competitive advantage.
Pictures used in this newsletter were generated by AI.