Paul-Ehrlich-Institut

Today is World Hepatitis Day – July 28 marks the birthday of Dr. Blumberg, the discoverer of the hepatitis B virus. Hepatitis is an inflammation of the liver caused by type A, B, C, D, or E hepatitis viruses. Liver disease can lead to a number of health problems, some of which can be fatal. HBV and HCV are particularly threatening, leading to chronic diseases in hundreds of millions of people. Together they are the most common cause of liver cirrhosis, liver cancer, and deaths associated with viral hepatitis worldwide. According to estimates by the World Health Organization (WHO), 304 million people worldwide live with a hepatitis B or C infection. Vaccines are available in Europe to protect against hepatitis A and B. The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, performs a variety of tasks connected to the development and provision of safe blood products and safe, effective vaccines to protect against hepatitis infections. Check out which vaccines are available against hepatitis A: https://lnkd.in/enkijjkJ and against hepatitis B: https://lnkd.in/eST7462K #worldhepatitisday #hepatitis

Notification for Applicants and Sponsors of Clinical Trials – The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)) provide recommendations on complex clinical trials in mono-national clinical trials in the early development phase (early phase complex clinical trials). Read the recommendations here 👉 https://lnkd.in/ezeHvYdY #clinicaltrials

Replacement of animal tests – The European Pharmacopoeia Commission, with the participation of the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, and the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)), removed the rabbit pyrogen test from 57 pharmacopoeial monographs during its 179th session in June 2024. This change is a milestone in the development of the European Pharmacopoeia in terms of the replacement, reduction, and refinement (RRR) of previously legally prescribed animal experiments in medicinal product testing. The rabbit pyrogen test was first developed in the 1940s. The test involves measuring the increase in rabbits' body temperature after they have been injected intravenously with the test substance. Fever-causing substances known as pyrogens and endotoxins can be detected with this test. Since its creation, the rabbit pyrogen test has been an important test in medicinal product development for the early detection of impurities that could cause life-threatening side effects in patients. It took about 20 years to develop alternative methods and to be able to provide evidence of their equivalence to the animal model with substantial data. 👉 https://lnkd.in/eWVGg7wC

News from regulation – The June #CHMP meeting highlights are online. The Paul-Ehrlich-Institut reports on new recommendations for marketing authorisation, extensions of therapeutic indication and recently started marketing authorisation procedures. 👉 https://lnkd.in/emhbWX-C 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

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