drug safety

Pharmacovigilance: a focus on EU drug safety excellence

A compelling model for small and medium-sized organizations in the current EU regulatory landscape Regulatory dynamics in the EU continue to evolve, with higher expectations for pharmacovigilance (PV) as each nation has rigorous and complex patient safety regulations. The shifting landscape represents a unique challenge for small- and medium-sized enterprises …


Transforming pharmacovigilance operations through automation and cognitive technologies

Traditionally the pharmacovigilance (PV) function has been responsible for collecting, assessing and reporting adverse events (AEs) and related drug safety information to regulators. Because PV is so process driven, companies have had to invest in safety systems to organize data and optimize efficiency. Yet these closed systems, including home-grown systems, …

The impact and use of social media in pharmacovigilance

Pharmacovigilance (PV) has evolved and grown more complex over the past 5 to 10 years due to increasing data volumes, evolving regulations, influence of emerging markets and the emerging social media and innovative technological advances. Digital media is now used by biopharmaceutical companies for communication with patients to create awareness about diseases and treatments, clinical …

Pharmacovigilance & risk management for biosimilars: unique challenges & possible solutions

Biological medicines (biologics) have made substantial contributions to the treatment of many chronic and serious diseases such as cancers, chronic inflammatory diseases and some rare genetic disorders, and are expected to provide significant therapeutic benefits to many patients who would otherwise have had limited treatment options.