Welcome to our monthly newsletter: your place for the latest industry and regulatory news in the world of Pharmacovigilance and AI!
Pharmacovigilance market set for growth: projected to reach $18.52 billion by 2032
The global pharmacovigilance market is expected to experience significant growth, reaching $18.52 billion by 2032. This rise is driven by increasing drug safety concerns, regulatory requirements, and the rising incidence of adverse drug reactions (ADRs).
The market's expansion is also supported by technological advancements in drug monitoring and reporting systems. As the pharmaceutical industry continues to grow, the need for comprehensive pharmacovigilance services is becoming more critical, ensuring patient safety and compliance with global regulatory standards. For more detailed information, visit here.
Upcoming EMA workshops: AI and Big Data Focus
The European Medicines Agency (EMA) is set to host two significant events in November, highlighting advancements in artificial intelligence (AI) and big data within the pharmaceutical industry.
The HMA-EMA Multi-Stakeholder Workshop on Artificial Intelligence, scheduled for 5 November 2024, will bring together regulators, industry experts, and other stakeholders to explore the integration of AI technologies into drug development and regulatory processes. The workshop aims to update stakeholders on the current policy and legislative environment and recent HMA/EMA activities related to AI. For more information visit here.
Following closely, the Fifth HMA-EMA Big Data Stakeholder Forum on 28 November 2024, will focus on the transformative impact of big data on medicine and public health, gathering experts to discuss the latest developments in big data analytics, data sharing, and their implications for regulatory science. For more information and updates, visit the EMA’s official website here.
EMA introduces new framework for Qualified Person for Pharmacovigilance (QPPV)
The European Medicines Agency (EMA) has introduced a new organisational framework for the Qualified Person for Pharmacovigilance (QPPV) and the EU QPPV role, as outlined in their latest document. This updated structure is designed to improve the monitoring and management of pharmacovigilance activities within the European Union.
Key changes include improved processes for the appointment and role of the QPPV, changes in the way pharmacovigilance information is reported and reviewed, and stricter requirements for maintaining compliance with safety regulations. For further information and detailed guidelines read more here.
Key FDA approvals and decisions: highlights from August 2024
The BioSpace FDA Decision Tracker provides real-time updates on drug and medical device approvals, rejections, and pending decisions. In 2023, the FDA approved 55 new drugs and 34 cell and gene therapies. Recent updates include Ascendis Pharma’s Yorvipath for hypoparathyroidism, ARS Pharmaceuticals’ neffy as the first nasal epinephrine spray, and Lykos Therapeutics’ MDMA-assisted therapy for PTSD being rejected.
Also noteworthy are Citius Pharmaceuticals’ Lymphir for T cell lymphoma, Novartis’ Fabhalta for IgA nephropathy, and Adaptimmune Therapeutics’ Tecelra for synovial sarcoma. GSK’s Jemperli and Johnson & Johnson’s Darzalex Faspro received new indications for advanced cancers. To learn more, click here.
FDA Rumor Control: combating misinformation and providing accurate information
The FDA’s Rumor Control page is an essential resource for addressing and clarifying misinformation about medical products and regulatory processes. With the increasing spread of rumours, misinformation, and disinformation about science and medicine, this page aims to provide accurate, evidence-based information. It helps clarify common myths and misconceptions, ensuring public and healthcare professionals have access to reliable facts.
The page also addresses misleading claims about FDA approvals, offering clarity on what "FDA Approved" really means for products and what it does not. Don't be misled by misinformation— visit the FDA’s Rumor Control page for the facts and stay informed.
Case report series from biologit
Here at biologit, our vision is to ensure patient safety by simplifying the detection of risks and safety events from development to post-market.
Our safety surveillance platform is uniquely designed to identify adverse events from biologit biomedical literature database and purpose-built AI workflow.
Read more about a recent case found by the biologit platform in biomedical literature where a patient experienced severe localised colitis in the setting of recent surgery and chronic ocrelizumab use. Read more by clicking here.
FutureVigilance Series: Artificial Intelligence beyond the buzz
Join us on Aug 29, 2024, for the Second Webinar in Our FutureVigilance Series: "Artificial Intelligence beyond the buzz". In this engaging session, we will explore how AI is transforming drug safety monitoring, from predictive algorithms that flag potential adverse events before they happen, to AI-driven automation that streamlines the reporting and analysis processes.
Our expert speakers will share insights on the current state of AI in pharmacovigilance, discuss the ethical and regulatory considerations, and offer a glimpse into the future of AI-enabled patient safety. Save your spot now! To register please click 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.
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