Welcome to From Data to Evidence, our monthly newsletter with the latest industry and regulatory news in the world of Pharmacovigilance and AI!
Literature Databases for Regulatory Searches
Do you know what literature databases you can use for your regulatory literature searches?
There is often confusion around which databases can be used for regulatory literature searches, and many people think that they are required to subscribe to expensive subscriptions to meet requirements.
In this article, we explore regulatory requirements for literature monitoring and how biologit offers an affordable and cutting-edge scientific literature database ready for any regulatory need. Learn more
Recent Conference Insights
Our biologit CEO, Nicole Baker recently attended the DIA Global Pharmacovigilance and Risk Management Strategies meeting in Baltimore.
The overarching takeaway is that we need to start looking at the benefit-risk balance of a product much earlier in clinical development and throughout the lifecycle of the product.
AI is everywhere, but one size does not fit it all - it is important to start early and find the best solution for your needs. There was a lot to learn also from attending the Good Pharmacovigilance Practice (GPvP) Symposium 2024 held by the Medicines and Healthcare Products Regulatory Agency.
Key takeaways included that the Agency has not inspected many MAHs that have already implemented AI. In addition, the PSMF is expected to describe the processes where AI is been used, so there is a lot to be learned for the future. Learn more about the MHRA GPvP symposium here.
FDA Smartwatch Safety
Communication
The FDA has released a safety communication regarding the risks related to using smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin.
Unlike FDA-approved blood glucose measuring instruments such as continuous glucose monitoring devices (CGMS) that penetrate the skin, these unauthorized smartwatches or smart rings may yield inaccurate blood glucose readings, potentially causing inaccuracies in diabetes management. Learn more here.
Pharmacovigilance for Veterinary Medicines in the UK
Veterinary pharmacovigilance involves closely monitoring the safety and efficacy of veterinary medicine. Recently, the UK government has issued its response to the Veterinary Medicines Directorate’s (VMDs) consultation on the proposals to amend and supplement the Veterinary Medicines Regulations 2013.
The pharmacovigilance proposals aim to harmonise, where possible, with the approach taken in the EU. The VMD has created a helpful document summarising the government’s response. Learn more here.
Commission welcomes political agreement on AI Act
Here at biologit, we are incredibly excited about the work we are already doing with AI to enhance literature monitoring for pharmacovigilance.
We are closely watching the industries across the world that are being transformed by its potential, as well as the regulatory response.
The use of artificial intelligence in the EU will be regulated by the AI Act, the world’s first comprehensive AI law. Recently, European Parliament reached a provisional agreement with the Council on the AI act.
The agreed text will now have to be formally adopted by both Parliament and Council to become EU law. Ursula von der Leyen, President of the European Commission, said: “Artificial intelligence is already changing our everyday lives. And this is just the beginning. Used wisely and widely, AI promises huge benefits to our economy and society. Therefore, I very much welcome today's political agreement by the European Parliament and the Council on the Artificial Intelligence Act.” Learn more here.
About biologit
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biologit MLM-AI is a complete literature screening platform built for pharmacovigilance, medical device and veterinary vigilance teams. Its flexible workflow, unified global scientific database, which includes local journals and unique AI productivity features deliver fast, inexpensive, and fully traceable results for any screening needs. Teams can save up to 70% of their time and work collaboratively across departments.
