Last August we travelled to Canada to take part in the International Conference of Pharmacoepidemiology (ICPE) 2023, accompanied by Teamit’s CEO Eva Molero. The long flight was well worth it as we had the opportunity to join more than 2,.000 members at this event and delve into a topic close to our heart: quality standards essential for non-interventional studies. Teamit Institute‘s was well represented at this large-scale conference with a total of 9 presentations and contributions. Below we share our experience, as well as take-aways.
Organised by the International Society for Pharmacoepidemiology (ISPE), this year’s conference took place in the picturesque town of Halifax, Nova Scotia, Canada from 23-27 August. The conference’s theme ‘The Global Home for the Science of Real-World Evidence,’ perfectly encapsulated the essence of our work, which is that of study management—especially that related to quality overall—is of growing importance as the number of multi-country studies continues rising.
In this regard, our main presentation titled “Quality Compliance While Conducting NIS Studies: Critical Success Factors Assessment and the Use of Key Performance Indicators by Yefimenko et al, 2023 ” delved into the quality standards essential for non-interventional studies (NIS). These studies serve as crucial post-marketing surveillance tools, generating real-world evidence regarding the use, effectiveness and safety of medicines for patients’ benefit.
Whilst regulatory authorities’ recommendations ensure reliable results and traceability, existing regulations and guidelines predominantly emphasise transparency and critical scientific thinking. This leaves a gap in the incorporation of key performance indicators (KPIs) and critical success factors (CSFs). Our study aimed to bridge this gap by developing guidelines to standardise quality compliance in NIS.
To achieve this, we conducted a comprehensive assessment by reviewing the quality requirements and KPIs outlined in the regulatory guidelines of the European Medicines Agency (EMA) and Food and Drug Administration (FDA). Additionally, we evaluated challenges associated with NIS preparation and execution through focused group discussions involving stakeholders such as investigators, study team members and study requestors. Collecting insights from 12 previous studies enabled us to map quality compliance gaps at various stages of NIS studies (More details here)
Our involvement in ICPE 2023 extended beyond this presentation alone, with a total of nine presentations and contributions. These achievements, indeed, highlighted our commitment to advancing the field of pharmacoepidemiology, particularly in the context of COVID-19. For a list of our featured presentations, visit here.
In addition, as Teamit Institute is an active member of VAC4EU (Vaccine monitoring Collaboration for Europe), we had the opportunity to meet with our member colleagues during the conference reinforcing our commitment to advancing Real-World-Evidence-based collaborative research.
In closing, we can say that Teamit Institute’s journey to ICPE 2023 in Halifax parallels the explorers of the past who ventured into uncharted territories. Just as those explorers paved the way for new possibilities, Teamit continues to navigate the ever-evolving landscape of pharmacoepidemiology research, pushing the boundaries in quality management.
Looking forward to the 40th IPCE in Berlin in 2024!
