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.
One of the promises of AI is that it can reduce workloads so employees can focus more on higher-value and more engaging tasks. But according to new research, AI tools don’t reduce work, they consistently intensify it.
Sanofi and Bavarian Nordics are amongst the recipients of eight-year EU vaccine contracts that will help bring new products to market.
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk
And much more...
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk
Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products
This guidance clarifies the expectations on the application of the further pharmacovigilance provisions set out within the updated CIR 520/2012 for UK authorised products.
One of the promises of AI is that it can reduce workloads so employees can focus more on higher-value and more engaging tasks. But according to new research, AI tools don’t reduce work, they consistently intensify it.
Regulatory expectations in the drug safety industry have evolved faster in the past five years than in the previous two decades combined. The US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other global authorities now expect safety reporting to deliver comprehensive, reliable and transparent data.
H1 CEO Ariel Katz shares how AI, regulation and pricing shifts are changing clinical trials and commercialization.
Sanofi and Bavarian Nordics are amongst the recipients of eight-year EU vaccine contracts that will help bring new products to market.
Today, the U.S. Food and Drug Administration took additional steps to support the transition of our nation’s food supply from the use of artificial petroleum-based colors to alternatives derived from natural sources.
A spike in M&A activity and stock prices have pulled biotech out of a yearslong downturn. But regulatory tumult and fierce competition from China could short-circuit the sector's resurgence.
Pictures used in this newsletter were generated by AI.