📣 EMA’s safety Committee, the #PRAC, just elected Ulla Wändel Liminga from the Swedish Medical Products Agency (Medical Products Agency Läkemedelsverket) as its new Chair for a three-year mandate starting in September 2024. Congratulations! 👏 She will take over from Sabine Straus, a member of the Dutch national competent authority, the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen), who has chaired the PRAC for 6 years, including during the COVID-19 pandemic. A huge thank you to Dr Straus for her relentless commitment to public health and exemplary leadership in incredibly difficult times. 🙌 Read more in the news announcement: https://lnkd.in/gv5KR9rn
Bravo. I may had that Selenite (Na2SeO3: (i) selenium (Se) supplementation (ii) cytotoxic drug depending on concentration and (iii) poison. Selenite could be an active ingredient (AI) when admistrating IV selenite outside NOAEL and even LOAEL (400, 900 microgram Se/day ) especially using bolus. In that case selenite could reach blood cytotoxic concentration. For concentration > 1 to 5 micromol Se as selenite is a cytotoxic drug: - It’s general toxicity dose is similar to those of arsenic salt. Approximate weight of three cafe beans 🫘reach lethal dose. - It has been studied since a long time as a chemotherapeutic agent in cell and phase I study (Brodin 2015). It induce redox cycling (eg DNA, mitochondria, reticulum) - It is teratogenic, mutagenic and possibly carcinogenic When used above LOAEL and in bolus, selenite should be considered as an AI requiring accurate drug development including preclinical studies before testing in patients. More details : Forceville X, Van Antwerpen P, Annane D, Vincent JL. Selenocompounds and Sepsis-Redox Bypass Hypothesis: Part B-Selenocompounds in the Management of Early Sepsis. Antioxid Redox Signal. 2022 Nov;37(13-15):998-1029. PMID: 35287478. https://doi.org/10.1089/ars.2020.8062
Thank you Sabine for your outstanding PRAC leadership and Congratulations Ulla on becoming our new PRAC Chair ☘
Two very extraordinary women in the world of Pharmacovigilance. Thank you so much Sabine for all the your outstanding PRAC leadership and Many Congratulations to Ulla on becoming the new PRAC Chair!👏
Thank you! Sabine Straus you did an extraordinary job during the last 6 years and also the years before as an outstanding member of the PRAC.
Ulla, good luck I am sure you’ll do great! And Sabine a fantastic job fulfilled, thanks for looking after us and watching over medicine safety during (especially) those taxing pandemic years!
Cheers to you and looking forward working together with you 👏
Congratulations Ulla Wändel Liminga ! 👏🏻 & thank you so much Sabine Straus for being such an excellent chair over the past years ! 💐
Greatest admiration for what you’ve done and achieved in and for the PRAC Sabine. I’m greatful and proud that you’ve put so much effort into a very strong European safety system for medicines! My congratulations for Ulla Wändel!
thank you Sabine Straus for a job extremely well done over the last few years, and Dr Liminga, wishing you much success.
Scientific adviser on safety of medicines bei European Medicines Agency
1moThank you Sabine for all the extraordinary PRAC years and congratulations Ulla for the new position!