Welcome to our monthly newsletter: your place for the latest industry and regulatory news in the world of Pharmacovigilance and AI!
Ensuring trust in artificial
intelligence and machine learning in pharmacovigilance: new insights from Uppsala Reports Podcast
Uppsala Monitoring Centre’s Uppsala Reports recently released a podcast episode discussing the importance of building trust in the use of artificial intelligence (AI) and machine learning (ML) within pharmacovigilance.
As AI/ML technologies become increasingly integrated into the monitoring and analysis of drug safety data, ensuring transparency, accuracy, and ethical considerations is critical. The podcast explores into the challenges and opportunities presented by AI/ML, highlighting the need for clear regulatory frameworks and stakeholder collaboration to maintain trust in these developing technologies within the field of drug safety. For more information, listen to the podcast episode here.
EMA explores the use of Large Language Models (LLMs) in medicines regulation
The European Medicines Agency (EMA) has published insights on how AI particularly Large Language Models (LLMs), can be harnessed to enhance medicines regulation. LLMs, a type of AI capable of processing vast amounts of textual data, offer potential in areas such as pharmacovigilance, regulatory submissions, and data analysis. The EMA aims to explore how these advanced models can improve efficiency and decision-making processes while ensuring the safety and efficacy of medicinal products across the EU. For more detailed information, visit the original article here.
EMA recommends new measures to minimise risks associated with Metamizole
The EMA has recommended new measures to reduce the risk of serious side effects linked to the widely used painkiller metamizole.
Following a safety review, the EMA highlighted the need for stricter guidelines on its use to prevent rare but severe outcomes, such as agranulocytosis (a dangerous drop in white blood cells).
These measures aim to improve patient safety while maintaining access to an effective pain management option in specific cases. Healthcare professionals are advised to closely monitor patients and adhere to updated guidelines. For more information, visit here.
Human Medicines Regulation Updates – GVP Updates
On 26th July 2024, the EMA introduced updates to the Good Pharmacovigilance Practices (GVP) definitions with the publication of Annex I. This revision involved both the removal and addition of specific definitions, reflecting advancements in regulatory frameworks and practices.
Following this, on 5th August 2024, the final revision 3 of Module XVI, focused on Risk Minimisation Measures (RMMs), and Addendum II, which deals with the evaluation of RMM effectiveness, were issued.
The revised guidance applies primarily to new marketing authorisation applications and newly implemented or amended RMMs, becoming fully applicable from 26th August 2024. While it doesn’t affect existing RMMs or ongoing evaluations, the updated guidelines should be considered if the changes can improve risk management without disrupting the product's use by patients and healthcare professionals.
For further details, please refer to the following links: GVP Annex I Definitions (europa.eu); 28 GVP Introductory Cover Note - M XVI Rev 3 M XVI ADD II A I Rev 5 (europa.eu); Module XVI – Risk minimisation measures (Rev 3); Module XVI Addendum II – Methods for evaluating effectiveness of risk
FDA Update: AI/ML-Enabled Medical Devices Reach New Milestone
On 12th August 2024, the U.S. Food and Drug Administration (FDA) released an updated list of AI/ML-Enabled Medical Devices. With this latest update, the FDA has now authorised 950 AI/ML-enabled medical devices, marking a significant milestone in the integration of advanced technologies into healthcare.
These devices, designed to enhance diagnostic, therapeutic, and monitoring capabilities, reflect the FDA's ongoing commitment to ensuring the safety and effectiveness of AI-driven innovations in the medical field. For more details, visit here.
Stepping stones and next steps: the first year of the FDA's Animal & Veterinary Innovation Agenda
In September 2023, the FDA launched the Animal and Veterinary Innovation Agenda, a strategic plan focused on advancing both human and animal health by promoting innovative veterinary products and streamlining regulatory processes.
Key initiatives include the "Accelerating the Development of Veterinary and Animal Needs" (ADVANce) program, aimed at addressing unmet animal health needs, and the expansion of the Veterinary Innovation Program (VIP Plus) to support novel product development. Additionally, a third-party review of the FDA's animal drug approval process is underway, with results expected by December 2025, underscoring the FDA's commitment to innovation and public health. For more information, visit here.
The next ISO 9001 revision: enhancing quality management standards
On 9th August 2024, the latest revision of the ISO 9001 quality management system standard was released, incorporating significant updates aimed at improving overall quality management.
The new version emphasises risk-based thinking, strengthening the role of leadership, and enhancing customer satisfaction. These updates reflect a more proactive approach to managing quality, encouraging organisations to integrate risk management practices and maintain a strong focus on customer needs throughout their operations. For more information, visit here.
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