Welcome to our monthly newsletter: your place for the latest industry and regulatory news in the world of Pharmacovigilance and AI!
Artificial Intelligence (AI) Act
At biologit, we support the safe and ethical use of AI, and are staying close to regulatory changes in this rapidly evolving space. On May 21, 2024, the Council of the European Union approved the Artificial intelligence (AI) Act, the first comprehensive global regulation for artificial intelligence, to ensure AI development and usage are ethical, transparent, and respect fundamental rights.
The Act categorises AI systems by risk levels - minimal, limited, and high - with corresponding regulations, bans harmful practices like behaviour manipulation and exploiting vulnerable groups, and requires transparency so users know when they are interacting with AI.
For more information, visit: Artificial intelligence (AI) act: Council gives final green light to the first worldwide rules on AI - Consilium (europa.eu)
EMA Medical Literature Monitoring (MLM) Expansion
Marketing authorisation holders in the European Economic Area typically oversee literature monitoring and adverse event reporting for their medicines. However, the European Medicines Agency (EMA) offers a medical literature monitoring (MLM) service for substances with multiple authorisations and holders.
This service, operational since September 2015, expanded on April 1, 2024, to include MEDLINE. The information from MEDLINE was already included in the EMBASE searches (along with many other journals too), but this change now means that the articles will be available sooner. For substances not under MLM coverage, MAHs must monitor literature and utilise reference databases with extensive article collections, as per GVP Module VI.
At biologit we provide an FDA and EMA GVP-compliant scientific literature monitoring platform with an in-built scientific database. Our database includes PubMed, Crossref, DOAJ and many other sources. Our database also offers global and local coverage with over 50 million entries, 30,000 new daily entries, spanning more than 110,000 journals, and encompassing over 165 countries.
For more detailed information on EMA’s MLM service and the databases it uses, you can refer to the EMA's detailed guide on medical literature monitoring (European Medicines Agency).
Find more safety events with the biologit Database: Oncology Case Study
The systematic monitoring and review of medical literature for pharmacovigilance requires a robust and comprehensive database with broad coverage. In this recent case study, our PV/QA Manager, Sarah Jane Devaney investigates the value of including broad data sources in literature monitoring, and examines the results of a literature search using the biologit Database against PubMed alone.
Here we present the findings for Olutasidenib, a selective and potent isocitrate dehydrogenase-1 (IDH1) inhibitor. Olutasidenib was recently approved by the FDA and is indicated for the treatment of relapsed or refractory acute myeloid leukaemia (AML) in patients with a susceptible IDH1 mutation. In this search, the biologit Database retrieved 12 additional articles not present in PubMed, 8 were identified as having pertinent safety information.
Read more about how you can identify pertinent articles containing safety information from a single search by leveraging the broad and diverse reach of the biologit Database: Case Study: Comprehensive Data Sources for High Quality Literature Monitoring (biologit.com)
EU MDR and Medical Literature Monitoring
Did you know that medical literature monitoring is a key requirement for EU MDR?
The EU MDR (2017/745) mandates medical device manufacturers to actively monitor scientific literature for potential safety issues. This includes studies on the device itself, adverse event reports, and risk discussions.
The monitoring scope and intensity depend on the device's risk class. Manufacturers are responsible for defining relevant sources (databases, journals), establishing search procedures, and evaluating identified information. Based on the evaluation, they may need to investigate further, update risk plans, or report incidents. All activities and actions taken must be documented. The EMA complements this by monitoring specific substances and entering relevant information from literature into Eudravigilance, a central database for adverse event reporting. Effective literature monitoring is crucial for identifying potential safety concerns early and ensuring patient safety under the EU MDR.
For more information please see: Regulation (EU) 2017/745 of the European Parliament
Learn more about MDR requirements for literature searches in our article: https://www.biologit.com/post/literature-databases-for-regulatory-searches
Tune into our upcoming webinar
Are you interested in staying up to date with trends in pharmacovigilance?
We are excited to announce the first webinar series from biologit in partnership with Truliant Consulting entitled FutureVigilance: Process & Change Management on the 6th of June 2024 at 4 pm (GMT).
This is an excellent opportunity to gain innovative insights and strategies that are tailored specifically for the dynamic world of pharmacovigilance.
Join us on this transformative journey by securing your spot today! FutureVigilance Registration.
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.
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