Tag Archive for: pharmacovigilance

Pharmacovigilance translations must be done carefully, as the accuracy of translated documents has a direct impact on information evaluation and patient health and well-being. However, with volumes of non-English source documents increasing, the speed at which these translations are completed is also crucial, as any delays in communication can lead to serious consequences, such as harm to patients, legal liability, and missed regulatory deadlines for adverse event reporting.

The current resource-intensive approach to PV is facing real challenges as safety data evolves and makes moving to efficient and effective solutions crucial to guaranteeing continued patient safety. Integrating modern technologies, such as artificial intelligence (AI) – which also encompasses machine learning (ML), and natural language processing (NLP) – improves the process, reduces workload for PV professionals, and expedites the gathering and analysis of safety data.

ConTIPI’s expanded agreement with Indegene includes several services across the commercialization process, including sales, PRMA (pricing, reimbursement and market access), medical affairs, medical communications, pharmacovigilance, regulatory, marketing and commercial operations support.

Med Ad News talked to Ittai Dayan, M.D., co-founder and CEO of Rhino Health, about federated learning in clinical trials.

When seamlessly collaborating with partners on the same cloud-based safety solution, sponsors have real-time visibility and control while driving more efficient and faster processes. Easily scaling with more studies or data, modern pharmacovigilance (PV) applications are intuitive and designed for teams to work together globally.

Together, EVERSANA and Compai Pharma will provide medical and commercial resources to healthcare partners to support full market implementation and development for life science and pharmaceutical companies ready to expand into these markets.

Pharmacovigilance, the industry term for drug safety, was unfamiliar to most of the general public before March 2020. But as the coronavirus pandemic unfolded, its rapid spread thrust drug safety into the spotlight. The public is more aware of drug safety and health regulators’ role than ever — and as the demand for pharmacovigilance information rises, the industry has had to find ways to keep up — according to Beena Wood, VP of safety at ArisGlobal.

As organizations continue to evaluate and implement automation and AI technology, it is important to consider how increased use of technology should align with both industry best practices and regulations – and to proactively address how technology adoption will impact stakeholders involved in routine pharmacovigilance activities while ensuring deployment and implementation poses no risk to breaching guidelines or regulations.