EMA database aids safety monitoring
A study conducted by the European Medicines Agency (EMA) has shown that statistical methods using the EMA?s EudraVigilance database of adverse drug reaction reports can be used to detect drug safety issues "significantly earlier" compared with routine pharmacovigilance.
A study conducted by the European Medicines Agency (EMA) has shown that statistical methods using the EMA’s EudraVigilance database of adverse drug reaction reports can be used to detect drug safety issues “significantly earlier” compared with routine pharmacovigilance.
The study was published in Drug Safety, the journal of the International Society of Pharmacovigilance, and was conducted in relation to centrally authorised medicines. The EMA used a statistical signal detection method in the EudraVigilance database and found that safety issues could be detected earlier in about 54% of cases where a clinically important adverse drug reaction report was found (compared with routine pharmacovigilance).
According to a press statement from the EMA, the study “provides direct evidence for a strong additive role of Eudravigilance signal detection methods”. The agency also claims that the study underlines the importance of well established pharmacovigilance systems, such as active surveillance or the periodic safety update reporting, and concludes “a combination of routine pharmacovigilance and statistical signal detection provides the optimal safety monitoring with earlier detection and better management of safety issues”.
Although the study looks at statistical signal detection retrospectively, the EMA says it now routinely uses the method to strengthen signal detection for centrally authorised medicines to help it detect new or changing safety issues with medicines earlier.
Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies
November 21st 2024Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Ensuring Quality from the Start: Raw Materials Testing Support
November 21st 2024Raw Materials are the foundation of every biopharma product. Our ultimate guide highlights how our testing support can help you establish purity, identity, and quality standards, ensuring a smooth manufacturing process and adherence to regulatory requirements.
Ensure the Safety of Allogeneic Therapies with Advanced qPCR Testing
November 21st 2024Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ensuring comprehensive safety in every stage of the allogeneic therapy pipeline. Protect your products – and your patients- with industry-leading sensitivity and specificity.
