patient safety

The future of pharmacovigilance

Leveraging technology to transform patient safety The challenges of maintaining complex pharmacovigilance (PV) systems in a global, ever-evolving regulatory environment are increasing daily. With growing public awareness, social media connectivity and media scrutiny, pharmaceutical companies need to manage PV activities diligently. Cost-reduction pressures on one hand and the challenges of …

Pills

Overcoming the unique drug safety and regulatory challenges faced by small and medium biopharma

Leveraging an Integrated, Holistic Solution Small- and medium-sized enterprises typically do not have the resources and expertise to establish an internal pharmacovigilance (PV) operation, as this would divert valuable time and money from product development. As a result, clinical development or regulatory groups, which are not specialized in PV, often …

drug safety covid

Monitoring drug safety during COVID-19 – five key questions and answers

Identifying, recording, and reporting adverse events is vital for ensuring drug safety, both in the pre-marketing and post-marketing settings. Today, the COVID-19 pandemic makes these activities both more critical and more challenging. Let’s consider five key safety questions and answers:

pharmacovigilance

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, …

Medical writing for patients: An important niche

With evolving medical knowledge, there is an ever-increasing need to effectively facilitate knowledge transfer to key target audiences, especially patients and caregivers. Medical writing for patients must not only meet stringent good clinical practice standards and good publication practices but it must also communicate specific information in a clear, relevant and compelling …

Advancing Rare Disease Drug Development: Four Key Considerations for Market Access

Our industry is witnessing increasing growth in the rare disease market, thanks to financial and regulatory incentives to develop orphan drugs. This has been good news for both sponsors and patients, but the fact remains that rare disease trials are inherently challenging to run. In addition, completing a complex study …