Colleagues from SpringerNature recently took part in the 3rd Annual Risk Management and Pharmacovigilance summit in Vienna, with the following meeting report provided by Daniela Ranzani, Adis Business Intelligence Product Manager.
Traditional topics as well as best practice and case-study presentations remain at the core of the meeting, allowing attendees to share knowledge and diverse experiences. Regulation revisions were also discussed, with a spotlight on the GVP Modules V and IX updates. Attention to patients with dedicated programs was highlighted, and a presentation on social media listening reminded us all of the great power represented by such tools when used for PV, which also brings great challenges in terms of carefully managing this type of information.
The conference was an opportunity for us to catch up on the latest developments in pharmacovigilance and drug safety, including challenges and solutions, and to present our view of the EMA Medical Literature Monitoring service and options to integrate this in the existing workflows. We were not alone, as Novartis also shared their experience with the MLM service, which just entered its second year.
From our part, the exposure we have had to the service shows a series of benefits, some of which will start to consolidate as the service is refined and industry systems are adapted. Some limitations and challenges remain, as recognised by the Industry, especially when it comes to de-duplicating results coming from the EMA service and from a Company’s own literature searches: this often happens when organisations have extended responsibilities in many countries, including ex-EU countries, and for products that do not fall on the EMA MLM list (which includes 400 substances at the moment). The MLM service in fact monitors literature ICSRs for selected substances, in selected journals, and processes valid, reportable cases in the EEA alone. Other data, e.g. non-valid ICSRs or cases not associated to ADRs, to name a couple, as well as safety-relevant data and cases on non–EMA substances need to be sourced by Organisations separately.
MAHs may decide on the integration approach that suits their workflows best, as long as they comply with GVP guidelines for literature monitoring and are as comprehensive as possible. We tried to convey this message during our session also through two case studies, sure that everyone has found or will find an optimal solution –also through an open dialog with the Agency, who welcome the Industry’s feedback on the service.
We will certainly witness further developments in the ever-evolving field of Pharmacovigilance, and we look forward to catching up with everyone again for more Pharmacovigilance updates next year!