Graeme Ladds shares his thoughts on the new EU pharmacovigilance legislation for July 2012, specifically looking at expedited reporting, literature searching and the Periodic Safety Update Reports.

The requirement for a Pharmacovigilance System Master File (PSMF) has been in place since July 2012 for all Centrally Approved Products or at the time of the application or renewal for Nationally ...

Discover the revolutionary impact of generative artificial intelligence (GenAI) on drug safety in pharmacovigilance. Learn how this cutting-edge technology is transforming the industry.

During this period, it conducted 46 inspections of marketing authorisation holders (MAHs) and one of a pharmacovigilance service provider. Approximately 29% of those inspected had not undergone a ...

Enhance your pharmacovigilance operations with our comprehensive training course tailored for pharmaceutical and biologic companies. Gain insights into US, EU, and UK drug safety regulatory ...

Cheryl Key, MBBS, MFPM is head of pharmacovigilance/principal medic at ProductLife Group. Cheryl has more than 16 years of drug safety experience, working in pharmaceutical and biotech companies ...

Pharmacovigilance is a crucial aspect of patient safety and medical development and advancements and, with the help of AI, it has become even more effective in helping prevent adverse events for ...

Explore the concept of embracing a future-ready pharmacovigilance ecosystem and discover how advancements in technology and regulations are shaping the future of drug safety monitoring.

Local affiliates can be overwhelmed by the often-competing demands of global companies and local health authorities. They are invariably handling multiple responsibilities, including regulatory ...