The International Society of Pharmacovigilance (ISoP) has set up a Special Interest Group (SiG) on Risk Minimisation Methods for Asian Countries, aimed at elaborating novel risk-proportionate methods suitable for Asian countries with diverse health care systems, medical cultures, practices and resources. To learn about the aims and activities of this group, we spoke to Dr. J. Christophe Delumeau, one of its leading coordinators.
APAC is the third largest pharmaceutical market in the world, worth over USD 140 billion and rapidly growing. This increased market demand and activity brings an increased focus on pharmacovigilance, (PV) and drug safety. To accompany the growing importance of this topic, this eBook provides an overview of the PV regulations across several of the major markets in the APAC region, as well as an analysis of the key challenges obstructing PV harmonisation.
Artificial intelligence, medicine with microchips, contact lenses that monitor blood sugar levels - this is not science fiction - technology is truly transforming pharmacovigilance. But when are these technologies likely to impact your work? The answer is, sooner than you might think. Download this exclusive article to get the latest news about the technologies and trials that are set to transform pharmacovigilance.
ADRs are well known to under reported, both by medical professionals and patients. As a result, PV practitioners are considering whether the use of social media monitoring or specialised PV apps, could improve the volume and quality of adverse events during post-marketing safety surveillance. Whilst these practices are already underway in the USA, in this article we ask how effective are these practices and when will they become commonplace in Asia?
To help you understand the current standards and practices in Pharmacovigilance across Asia, this eBook provides a snapshot of the several of the major markets in the region. Then to provide an international comparison, we take a look at the changing pharmacovigilance requirements in the European Union, as a benchmark and indication of possible forthcoming changes influencing the Asia region. Click above to download.
Stricter guidelines on Risk Management Planning will have far-reaching consequences on PV practices. This article examines the challenges affecting this upcoming change and ways to improve PV in the Asian context.
The pharmaceutical industry continues to change at what feels like an exponential pace, so what can be done to move with this change rather than resist it?
This insightful article outlines what every CRO needs to know about solutions that are compliant with the SAFE-BioPharma standard.