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.
In February issue, we look at the newest advances in healthcare technology, such as artificial intelligence and machine learning. What are the possibilities of GPT-4 in healthcare and the current research on LLMs? What biases can arise using AI technology? We also share the latest regulatory changes, including data protection and privacy to keep PV experts updated.
The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period. A Step 2 Informational Presentation has also been developed by the Expert Working Group and is now available for download on the E2D(R1) page.
Clinical Trial Information System (CTIS) evaluation timelines
Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of a development medicinal product
Healthcare organizations are looking for the proper use of OpenAI, research on LLMs and bias in AI technology. Harjinder Sandhu, CTO of health platforms and solutions at Microsoft, has the answers.
This year, healthcare data experts will also begin to take on a new role as artificial intelligence trainers, contends Matt Hollingsworth, cofounder and chief innovation officer at Carta Healthcare, a healthcare AI systems company.
It’s not easy to get patients, providers, payers, vendors and regulators to agree on any one aspect of healthcare delivery. But the CDRH recently managed to get everyone to settle on a working definition of transparency.
Five questions to help leaders discover the right analytics tool for the job.
The 2 most commonly used scales worldwide are the World Health Organization–Uppsala Monitoring Centre (WHO-UMC) and the Naranjo scales. The present study was planned to assess the degree of agreement between the 2 scales when the same adverse drug reactions (ADR) were assessed by 5 raters independently.
Any drug that is taken orally must pass through the lining of the digestive tract. Transporter proteins found on cells that line the GI tract help with this process, but for many drugs, it’s unknown which of those transporters they use to exit the digestive tract.
Pictures used in this newsletter were generated by AI.