The Safety Platform for Emergency vACcines (SPEAC) Project

Wednesday, September 30, 2020 5:40 PM to 6:10 PM · 30 min. (Africa/Abidjan)
Vaccine Safety

Information

• The Brighton Collaboration was created in 2000 with the goal of building trust in the safety of vaccines via rigorous science.

• The Coalition for Epidemic Preparedness Innovations (CEPI) and the Brighton Collaboration launched the Safety Platform for Emergency vACcines (SPEAC) Project on May 28, 2020.

• SPEAC aims to support the emerging CEPI portfolio by creating practical solutions for harmonized safety assessment of CEPI vaccines by working:

o To enhance vaccine safety assessment across CEPI development programs.

o To harmonize vaccine safety monitoring during CEPI preclinical and clinical trials.

o To provide a continuous improvement framework for the SPEAC program.


Topics

Topics
Emergencies & OutbreaksLMICsvaccine safety assessmentsVaccine surveillance, hesistancy & confidence
IDT BiologikaIDT Biologika is a global biopharmaceutical contract development and manufacturing organization (CDMO) that specializes in the production of innovative live viral vaccines, viral vectors for gene and immune therapeutics as well as fill/finish of sterile liquid and lyophilized biologics to improve human health worldwide. We offer clients in B2B business a single source CDMO partner at our sites in Germany and the USA, with seamless end-to-end solutions and the ability to nimbly scale projects from development through to commercialization. This includes process development, drug substance manufacture, drug product manufacture, packaging, quality control/analytics and storage. IDT Biologika handles every step in manufacturing and packaging of small clinical batches as well as of products in a large-scale commercial scale. At its headquarters in Germany, IDT Biologika operates one of Europe’s premiere integrated facilities for end-to-end services from process development through clinical phases I-III to commercial manufacturing. In Rockville, MA, USA we utilize broad capabilities and a depth of technologies for process development and manufacturing of clinical trial material for phases I-II. Our fully integrated services are underscored by our commitment to quality and operational excellence that flows through our best-in-class process and cGMP (up to BSL2) manufacturing capabilities meeting EMA and FDA standards (ANVISA ready). Many human vaccines developed by IDT Biologika, together with international partners, are already in use, fighting infectious diseases such as tuberculosis, AIDS, malaria, cancer, dengue and ebola. On request of our clients we supply their products in vials, pre-filled syringes (with and without safety devices), autoinjectors or as combination products.