From March 6 to March 8, 2024, SIGMA Member RTI Health Solutions hosted a live, in-person course on Target Trial Emulation for Regulatory Real-World Evidence Generation in the beautiful city of Barcelona, in partnership with Leibniz Institute for Prevention Research and Epidemiology - BIPS. Numerous attendees from all over Europe joined Dr. Xabier Garcia de Albeniz, Prof. Dr. Vanessa Didelez, and Dr. Jaume Aguado for this amazing learning opportunity. The course provided participants with the resources to understand how to implement the target trial emulation framework in regulatory studies that use real-world data, including tools for causal inference, such as DAGs, and other resources for the design, analysis, and interpretation of causal regulatory studies using the target trial emulation framework.

On 18 January, 2024, the SIGMA Consortium welcomed Karolinska Institutet, Centre for Pharmacoepidemiology (CPE) as its newest Member Organisation. CPE was established in 2005 and has since then been involved in many international pharmacoepidemiological studies. CPE has been a research partner in more than 40 regulatory driven post authorisation safety studies (PASS) and drug utilisation studies. The researcher team has high level of expertise in the fields of pharmacoepidemiology/real-world evidence (RWE), biostatistics and Swedish health care register linkages. CPE is also involved in academic multicentre studies, such as NorPress and InPress. As a result, CPE also has extensive experience in collaborating with a wide range of parties, both from academia, authorities and industry.

Over the years, CPE has developed specific pharmacoepidemiological expertise in several areas such as reproduction, psychiatry and neurological diseases, and chronic and inflammatory diseases. A large part of their research is based on data from the national registers at the National Board of Health and Welfare and Statistics Sweden, as well as corresponding registers from other countries, especially the Nordic countries. Data from quality registers and medical records are occasionally also included in their research.

The SIGMA Consortium is beyond excited that this long-term SIGMA Collaborator has finally joined our Consortium and look forward to continue working with Dr. Johan Reutfors, Caroline Öberg and the rest of the CPE Team!

Between August 23-27, 2023, members of the SIGMA Consortium attended the 39^th annual Conference of the International Society for Pharmacoepidemiology (ISPE) in Halifax, Nova Scotia (Canada). SIGMA Members PHARMO Institute and RTI Health Solutions could not have been prouder to be able to feature SIGMA in their respective booths, and to share with everyone our collaborative research approach as the best ‘go-to’ organization for comprehensive and rigorous methodological pharmacoepidemiology/RWE research.

On 10 August, 2023, the SIGMA Consortium welcomed the Norwegian Institute of Public Health (NIPH) as its newest Member Organisation. The Pharmacoepidemiology research unit at the NIPH Department of Chronic Diseases is the largest pharmacoepidemiology research entity in Norway. The Team has extensive expertise and experience in pharmacoepidemiologic research covering a broad range of therapeutic areas and drug types, such as opioids, psychotropics, antidiabetics and drugs for other noncommunicable diseases. They work on safety studies on medicines, vaccines and biologics, including drug utilisation studies, pregnancy safety studies, and other analytic outcomes studies imposed by regulators (post-authorisation safety studies, PASS).

The NIPH runs the nationwide Norwegian Prescribed Drug Registry (NorPD), which they have been using since its inception in 2004. The NIPH team uses drug data linked to other relevant nationwide health and population registers available in Norway. These include medical birth registry, hospital registry, primary care registry, cancer registry, cause of death registry, socioeconomic data and more. They have also used the Norwegian Immunisation Registry on vaccinations, as well as linked the registry data to several large population-based health surveys and a national birth cohort study with biobanks. They have extensive knowledge on gaining access to and analysing the data, on data harmonisation and common data models (CDMs), as well as on the strengths and weaknesses of the different data sources. They have collaborated with researchers from several European countries as well as from Australia and the US. In addition, the NIPH team has experience working directly with person-level register data from other Nordic countries (Sweden, Finland, Iceland). Members of The SIGMA Consortium could not be more excited about this new addition and look forward to working with Drs. Øystein Karlstad, Ingvild Odsbu, Kari Furu and colleagues, and to benefiting from their valuable expertise in the field of pharmacoepidemiology and real-world evidence!

The SIGMA Consortium is thrilled to welcome the University of Eastern Finland as the newest Collaborator of our Consortium. We look forward to working with Professors Anna-Maija Tolppanen and Sirpa Hartikainen and colleagues, and to sharing our collective expertise and extensive experience in the field of pharmacoepidemiology and real-world evidence! 

The SIGMA Consortium was thrilled to attend the 38th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) between August 24-28 in Copenhagen. SIGMA Members and Collaborators enjoyed presenting our great consortium and the results of our research and, especially, seeing everyone in person!

Photo: SIGMA Executive Committee members Ron Herings (PHARMO Institute for Drug Outcomes Research), Susana Perez-Gutthann (RTI Health Solutions) and Vera Ehrenstein (Aarhus University)

In March 2022, the SIGMA Consortium and VAC4EU formally joined forces and expressed their shared vision and mutual goal to continue collaborating, developing existing synergies, and sharing expertise and knowledge, information, and tools developed by the two networks for pharmacoepidemiology/real world evidence studies and activities.