When assessing benefit risk for oncology drugs ... DLTs are reported directly into the pharmacovigilance team or to clinical study teams. Clear communication is needed between these teams to ...

These demands place companies at risk of falling foul of regulatory compliance requirements, particularly in pharmacovigilance ... Where traditional avenues of communication are not used ...

Montelukast does not appear to increase the risk for neuropsychiatric adverse events in children and adolescents, according to a study published in JAMA Pediatrics. Montelukast is a leukotriene ...

“Work smarter, not harder.” It’s a simple idea, but in risk management, it’s a game-changer. For 2025, risk professionals are ...

The researchers theorise the protective effects of these drugs could be because they reduce inflammation, control infections ...

The Contec CMS8000 patient monitors do not contain a malicious backdoor but are plagued by an insecure and vulnerable design.

ELIQUENT Life Sciences (ELIQUENT), a global regulatory, quality, and safety consulting firm, today announced the appointment of Rob Wojciechowski as Chief Operations Officer (COO). In this new role, ...

Registration Now Open for Pharmacovigilance Europe Conference 2025: Innovation, Integration and Advancing Global Pharmacovigilance In The Digital Age (London, United Kingdom - May 21-22, 2025) - ...

Develop strategies to better prepare your organisation for the future, with an interdisciplinary perspective on risk and crisis management. The COVID-19 pandemic's unprecedented impact on business and ...

The FDA says the cybersecurity vulnerabilities identified may put patients at risk when the device is connected to the internet.