Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia.

Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to delegate work on PV. This initiative was put in practice by our Inserm-ANRS MIE PV department in two distinct multinational European consortia with 19 participating countries: conect4children (c4c) for paediatrics research and EU-Response for Covid-19 platform trials. The centralized PV system consists of some key procedures to harmonize the complex safety processes, creation of a local safety officer (LSO) network and centralization of all safety activities. The key procedures described the safety management plan for each trial and how tasks were shared and delegated between all stakeholders. Processing of serious adverse events (SAEs) in a unique database guaranteed the full control of the safety data and continuous evaluation of the risk-benefit ratio. The LSO network participated in efficient regulatory compliance across multiple countries. In total, there were 1312 SAEs in EU-Response and 83 SAEs in c4c in the four trials. We present here the lessons learnt from our experience in four clinical trials. We managed heterogeneous European local requirements and implemented efficient communication with all trial teams. Our approach builds capacity for PV that can be used by multiple academic sponsors.

Governing Global Antimicrobial Resistance: 6 Key Lessons Fromthe Paris Climate Agreement

[...]mitigating the threat posed by AMR requires a recognition of how embedded social structures and incentives drive antimicrobial use across sectors. [...]escalating commitments through national AMR action plans, which outline each country's AMR goals and planned actions, will likely increase the effectiveness of global AMR efforts. Fifth, like the Intergovernmental Panel on Climate Change guiding the Paris Agreement, ongoing AMR action would be best informed by a regular and independent stock-taking to evaluate existing measures and advise on evidence-informed adjustments.11,12 This endeavor must (1) recognize that different ways of knowing constitute the global knowledge base, (2) ensure that using evidence to inform adjustments that work does not detract from the inherently political questions of works for what purpose and for whose benefit, and (3) come with a commitment to equitable evidence generation and prioritization. Striking a panel to assess the global knowledge base on these terms will ensure that global, regional, and national goals and policies are continually informed by the best available evidence and are in line with leading practices.12 Finally, an enduring international legal agreement could institutionalize requires new legal mechanisms beyond those available through the World Health Organization, the Food and Agriculture Organization of the United Nations, the World Organization for Animal Health, and the United Nations Environment Program, which are limited to the area-specific mandates of each institution.

Developing vaccines against epidemic-prone emerging infectious diseases.

Today's world is characterized by increasing population density, human mobility, urbanization, and climate and ecological change. This global dynamic has various effects, including the increased appearance of emerging infectious diseases (EIDs), which pose a growing threat to global health security.Outbreaks of EIDs, like the 2013-2016 Ebola outbreak in West Africa or the current Ebola outbreak in Democratic Republic of the Congo (DRC), have not only put populations in low- and middle-income countries (LMIC) at risk in terms of morbidity and mortality, but they also have had a significant impact on economic growth in affected regions and beyond.The Coalition for Epidemic Preparedness Innovation (CEPI) is an innovative global partnership between public, private, philanthropic, and civil society organizations that was launched as the result of a consensus that a coordinated, international, and intergovernmental plan was needed to develop and deploy new vaccines to prevent future epidemics.CEPI is focusing on supporting candidate vaccines against the World Health Organization (WHO) Blueprint priority pathogens MERS-CoV, Nipah virus, Lassa fever virus, and Rift Valley fever virus, as well as Chikungunya virus, which is on the WHO watch list. The current vaccine portfolio contains a wide variety of technologies, ranging across recombinant viral vectors, nucleic acids, and recombinant proteins. To support and accelerate vaccine development, CEPI will also support science projects related to the development of biological standards and assays, animal models, epidemiological studies, and diagnostics, as well as build capacities for future clinical trials in risk-prone contexts.