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.
Read about the first approval via the new International Recognition Procedure that MHRA grants in 30 days. How AI could speed up drug discovery, transform medical coding, or go to prison. Or not?? And how obesity is one of the biggest causes of malnutrition.
A new version of the EU Clinical Trial Regulation (EU CTR) guidance on "Auxiliary Medicinal Products in Clinical Trials (AxMP)" was released on the 1st of March. This revision encompasses information regarding unmodified authorised AxMPs, update on the classification as Investigational Medicinal Products (IMP) vs AxMP when the medicinal product is considered standard of care in background treatments, as well as a new Annex 2 featuring a flowchart outlining IMP and AxMP labelling requirements.
Launched in January 2024, IRP aims to further help bring life-saving new medicines to UK patients without delay
The Data Analysis and Real World Interrogation Network DARWIN EU seeks ten new data partners in 2024.
Revenue cycle management performance has never been more important. And recent advances in technology, particularly artificial intelligence, offer much potential for healthcare's administrative functions.
As healthcare AI opens new avenues to improve care quality without unduly increasing operational costs, the technology also expands potential exposure to civil and criminal liabilities. And that’s not only for providers but also payers and suppliers.
There are thousands of diseases worldwide with no cure or available treatments. Traditional drug discovery and development takes decades and billions of dollars and more than 90% of these drugs fail in clinical trials. The emergence of artificial intelligence (AI) holds promise for streamlining and improving the entire process. However, ushering in a new era of AI-driven drug discovery requires costly and lengthy validation in preclinical cell, tissue, and animal models and human clinical trials.
New study released by the Lancet shows that, in 2022, more than 1 billion people in the world are now living with obesity. Malnutrition, in all its forms, includes undernutrition, inadequate vitamins or minerals, overweight and obesity. Undernutrition is responsible for half of the deaths of children under 5 and obesity can cause noncommunicable diseases such as cardiovascular diseases, diabetes and some cancers.
While pharmaceutical companies aim to leverage real-world data (RWD) to bridge the gap between clinical drug development and real-world patient outcomes, extant research has mainly focused on the use of social media in a post-approval safety-surveillance setting. Recent regulatory and technological developments indicate that social media may serve as a rich source to expand the evidence base to pre-approval and drug development activities. However, use cases related to drug development have been largely omitted, thereby missing some of the benefits of RWD. In addition, an applied end-to-end understanding of RWD rooted in both industry and regulations is lacking.
Four factors that will determine the success — or failure — of your initiative.
Pictures used in this newsletter were generated by AI.