Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
EMA released Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials.
Adverse events (AEs) associated with medication and vaccine use are of significant concern in pharmacovigilance (PV), necessitating robust detection, documentation, and reporting mechanisms.
For some, the FDA is moving too fast in its drive to adopt generative AI agency-wide.
And much more...
The European Medicines Agency (EMA) collects and handles personal data in various situations. These documents describe why and how EMA does this and what users can do to object.
The EMA’s 30th anniversary scientific conference aims to celebrate three decades of groundbreaking achievements and advancements in the field of medicine and regulatory science.
Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials
For some, the FDA is moving too fast in its drive to adopt generative AI agency-wide.
Synapxe, Singapore's national health tech agency, is set to announce new digital healthcare applications, solutions, and partnerships following significant government investment.
National Taiwan University Hospital has recently launched a new AI-powered diagnostic imaging service for pancreatic cancer. Offered as a self-pay service at the NTUH Department of Medical Imaging since late 2024, it features an AI system touted as the first of its kind in the world.
EMA already has commitments and actions in place targeting and addressing gender equality, which can be considered as equivalent to the requirements of a GEP, however this is the first time all elements are brought together in a formal plan.
Adverse events (AEs) associated with medication and vaccine use are of significant concern in pharmacovigilance (PV), necessitating robust detection, documentation, and reporting mechanisms.
The Food and Drug Administration's approval in 2023 of lecanemab - a novel Alzheimer's therapy shown in clinical trials to modestly slow disease progression - was met with enthusiasm by many in the field as it represented the first medication of its kind able to influence the disease.
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