Paul-Ehrlich-Institut

Today is #WorldBloodDonorDay! 🩸 Blood donations can save lives – for 20 years, 14 June has been a reminder of how important blood donations are. They are indispensable for medical care in situations such as serious accidents, major operations, or the treatment of certain diseases. 💡 Blood products include blood components derived from human blood for transfusion and blood components derived from human plasma, from which important medicinal products can be obtained and processed. The Paul-Ehrlich-Institut tests and evaluates the safety of blood and blood products and provides transparent information on necessary measures. Learn more about blood products 👉 https://lnkd.in/ebkF762C

On 12 June, 2024, experts from the Paul-Ehrlich-Institut and representatives from the Association of Research-Based Pharmaceutical Companies (Verband forschender Arzneimittelhersteller, vfa) met for their annual exchange. Agenda topics included the possibilities for gaining more flexibility within authorisation procedures in connection with the EU Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS). The experts also discussed changes to the interfaces of EU medicinal product legislation and to the EU Regulations on In Vitro Diagnostics (IVDR) and Medical Devices (MDR) and other central medicinal product safety and authorisation topics. More information 👉 https://lnkd.in/ejZTAUNa

News from regulation – The May #CHMP meeting highlights are online. The Paul-Ehrlich-Institut reports on new recommendations for marketing authorisation, extensions of therapeutic indication and newly published EPARs. 👉 https://lnkd.in/ekXhnum6 The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) is responsible for the scientific assessment of the application dossier on the quality, safety and efficacy, including environmental safety, of a new medicinal product for human use as part of the centralised marketing authorisation procedure. The Paul-Ehrlich-Institut is represented in the CHMP as a co-opted member. #Biomedicines #Regulation

The architectural competition for the Paul-Ehrlich-Institut's new building in Langen was successfully completed at the beginning of November 2023. While negotiations are currently being organised with the prizewinning firms to determine the most economical offer, progress has been made in the integration of other types of technical planning for the building complex. The State Office for Construction and Real Estate in Hesse (LBIH • Landesbetrieb Bau und Immobilien Hessen) is now calling for tenders for two technical planning disciplines for the new building. Engineering and planning firms can now apply to participate in the award procedures for advanced technical planning/technical facilities and laboratory technology planning. Find out more 👉 https://lnkd.in/eDyfNRQW

New findings on how initial SARS-CoV-2 cell-entry route influences infection outcomes: An international research team has gained new insights into the way SARS-CoV-2 enters cells and its downstream consequences. As an aid to the ACE2 surface protein, the TMPRSS2 serine protease plays an important role in enhancing cell infection: it boosts the resulting immune response, increases cell death, and drives virus evolution. In addition to the human version, TMPRSS2 proteins from diverse mammal species can also enhance infection. These findings may contribute to the development of future treatments and prevention strategies. Proceedings of the National Academy of Science (PNAS) reports on these results in its print edition from 4 June 2024. Find out more 👉 https://lnkd.in/ehf3SUT9

This week, communication experts from national medicines authorities and their colleagues from the European Medicines Agency met in Brussels for the WGCP (Working Group of Communications Professionals) meeting. During this inspiring session, they refined the joint communication strategy and prepared specific actions to even better inform patients and stakeholders. They took the opportunity to show the results of interesting communication actions to each other, such as:  🌐 #PharmaInfo - The new Belgian website for patients 🌿 A Dutch campaign on interactions between medicines and herbs  🔄 A Finnish campaign on substitution of biological medicines  📱 A Norwegian campaign on the digital package leaflet Guest speakers from the Nationaal Crisiscentrum and European Food Safety Authority (EFSA) also presented some fascinating insights. The WGCP is proof that collaboration and sharing best practices on communication are essential for promoting public health.  #WGCP #BE2024EU

The Paul-Ehrlich-Institut is participating in the Democracy Festival in Berlin today. Meet us at the booth of the Federal Ministry of Health. Learn interesting facts about biomedicines and test your knowledge of the Paul-Ehrlich-Institut in a quiz. When? Friday, 24th May 2024, from 2- 7:30 pm Where? Booth No. 3, Paul-Löbe-Allee, Berlin Find out more 👉 https://lnkd.in/ePSFCy6e

Celery, a major cause of vegetable allergies, carries the risk of causing severe allergic reactions, especially in individuals with mugwort pollen sensitisation. A recent clinical study points to the significant role of defensin as a cross-reactive allergen in mugwort pollen (Art v 1) and celery (Api g 7) and its association with severe and potentially life-threatening allergic reactions to celery. Immunoglobulin E testing for Api g 7 could represent an important biomarker to identify individuals at an increased risk of anaphylaxis. 👉 https://lnkd.in/eY_NXmPt

Today is International Clinical Trials Day 2024. The Paul-Ehrlich-Institut is the German authority responsible for the evaluation and approval of clinical trials in the field of vaccines and biomedicines. #ClinicalTrialsDay Find out more 👉 https://lnkd.in/e2FsTr55

News from regulation – The April #CHMP meeting highlights are online. The Paul-Ehrlich-Institut reports on a new recommendation for marketing authorisation, extensions of therapeutic indication and recently started marketing authorisation procedures. 👉 https://lnkd.in/eVCbteQh The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) is responsible for the scientific assessment of the application dossier on the quality, safety and efficacy, including environmental safety, of a new medicinal product for human use as part of the centralised marketing authorisation procedure. The Paul-Ehrlich-Institut is represented in the CHMP as a co-opted member. #Biomedicines #Regulation