Latest Updates from EMA and EC regarding Signal Detection Process
Signal Detection in Pharmacovigilance is a set of activities that aim to search for and identify safety signals from a wide variety of data sources. This process wants to determine whether there are new risks associated with a particular drug, or whether risks associated with a particular drug have changed.
The European Medicines Agency (EMA) and the European Commission have recently agreed to further extend the pilot phase of signal detection performed by some MAHs on EudraVigilance data, until the end of 2022.
So that, by the beginning of 2023, all MAHs will be obliged to integrate their own Signal Detection process with the analysis of data from EudraVigilance with the requirement of systematic monitoring. The challenging aspect of analysing the EudraVigilance dataset is the large amount of data and the scientific evaluation of the disproportionality analysis results. The interpretation of data mining outputs should consider the known safety profile and pharmacology of a medicinal product, knowledge of the patient populations being treated, biological plausibility, and alternative etiologies for suspected adverse drug reactions.
At seQure, the business unit of Arithmos, related to Regulatory Compliance and Consulting Services, we are already supporting pharmaceutical companies involved in the pilot phase to put in place an effective and efficient process to ensure that signals are detected and managed in compliance with the regulatory requirements.
Abiogen Preferred seQure
Abiogen Pharma is an Italian-based pharmaceutical company developing innovation in the health area, making state-of-the-art solutions for the treatment of numerous diseases accessible, throughout its 100 years of history.
With a production hub in Pisa, Abiogen focuses its production, Research and Development activities in the therapeutic areas of bone metabolism, which has always been an area of excellence for the Company, in the treatment of pain, respiratory, metabolic (diabetes) and dermatological diseases.
Pharmacovigilance Unit of Abiogen is made up of expert scientists who are involved in many demanding tasks. It is paramount for them to have efficient and effective internal PV processes, focusing on core activities such as signal management.
Abiogen wants to get prepared, in the best way, for the upcoming obligation to monitor EudraVigilance database, putting in place a well-defined process running smoothly.
The SeQure Team started the project by preparing a concise procedure on how to classify each Signal of Disproportionate Reporting (SDR) highlighted in the electronic Reaction Monitoring Report (eRMR). The purpose of the procedure is that of helping in determining priorities and focusing on SDRs deserving more in-depth analysis.
A pilot phase has been performed in order to illustrate how to proceed using the proposed approach. Within the pilot phase, a signal detection report has been generated and presented.
The new process is implemented after a fine-tuning in regard to the specific needs of Abiogen.
The proposed solution has provided a robust and lean process to ensure Abiogen compliance with the upcoming regulatory requirement (monitoring of EudraVigilance data for signal detection) that will be effective in the European Economic Area (EEA) for all MAHs starting in 2023.
The process proposed by seQure for EudraVigilance was so successful that Abiogen proceeded with implementing a similar procedure for signal detection on their database as well, having excellent customer satisfaction.
seQure is the business unit of Arithmos, related to Regulatory Compliance and Consulting Services. We are delighted to use our expertise and tailored approach to help Abiogen Pharma put in place an effective and efficient process to ensure that signals are detected and managed in compliance with the regulatory requirements.
We will evaluate with you the best approach for your business processes.