Webinars

EMA will be releasing a revised GVP module VI in the near future and R3 has been widely discussed for several years and will be implemented this year. Each of these changes is likely to have a significant impact on safety and...

In the face of dwindling drug pipelines, stringent drug regulations, and block-busters crossing their patent exclusivity, mature and established products offer an opportunity for companies to sustain their revenues and bottom lines in the increasingly challenging pharmaceutical market. Compared to new products,...

Warning letters are issued by the US FDA when, based on available evidence, it has found that an organization has violated a specific rule in a regulated activity. While they are characteristically informal and advisory, their ultimate aim is to establish voluntary...

Poor quality ICSR data impacts the ability to conduct safety surveillance activities and forces regulators and independent groups to question the overall quality of the pharmacovigilance system. Learn best practices and recommendations that can be employed to improve case quality, avoid feedback...

Product labeling teams are accountable for driving both timely and accurate benefit: risk communications and ensuring demonstrable process performance. To do this, they must be adept at providing a critical link between upstream information providers (e.g. clinical development, pharmacovigilance) and downstream implementers...