A5081601969- Blood donation and transfusion practices
- Pharmacovigilance and Adverse Drug Reactions
- Pharmaceutical Quality and Counterfeiting
- Pharmaceutical studies and practices
- CRISPR and Genetic Engineering
- Biosimilars and Bioanalytical Methods
- Vaccine Coverage and Hesitancy
- Blood groups and transfusion
- Virus-based gene therapy research
- Academic integrity and plagiarism
- RNA Interference and Gene Delivery
- Pharmaceutical Economics and Policy
- Hemoglobinopathies and Related Disorders
- HIV/AIDS Research and Interventions
- Blood transfusion and management
Paul Ehrlich Institut
2018-2023
Utrecht University
2019-2023
Delivering genes selectively to the therapeutically relevant cell type is among prime goals of vector development. Here, we present a high-throughput selection and screening process that identifies designed ankyrin repeat proteins (DARPins) optimally suited for receptor-targeted gene delivery using adeno-associated viral (AAV) lentiviral (LV) vectors. In particular, includes expression, purification, in situ biotinylation extracellular domains target receptors as Fc fusion mammalian cells...
Introduction Independent assessments of blood regulatory systems, facilitated by tools such as the WHO's Global Benchmarking Tool (GBT) plus Blood expedites development National Regulatory Authorites (NRAs) and thus promotes increased access to safe, effective, quality blood, components, products. The aim this study was assess compare status implementation performance functions for registration marketing authorization well system approval components plasma fractionation or processes. Methods...
Haemovigilance is an important element of blood regulation. It includes collecting and evaluating the information on adverse events resulting from use components with aim to improve donor patient safety. We describe results pilot integrated GBT+ Blood for haemovigilance function in 10 sub-Saharan African countries.We piloted WHO Global Benchmarking Tool plus (GBT+ Blood) assess national regulatory authorities (NRAs) Ethiopia, Kenya, Malawi, Nigeria, Liberia, Rwanda, South Africa, Tanzania,...
blood and products selection of essential medicines low-and middle-income countries Blood human origin are treatment options for several diseases, example, hemophilia.We studied the alignment national lists (NEMLs) (LMICs) with World Health Organization (WHO) Model List origin.The most recent versions NEMLs from all LMICs were inclusion (blood components, plasma products, immunoglobulins).Data obtained 105 compared to 2017 WHO List.The median number on was 4 (range: 0-10).Immunoglobulins...
Since being designated as medicines by World Health Organization (WHO), blood components are subject to pharmacovigilance reporting. Using VigiBase, the WHO global database of individual case safety reports (ICSRs), we characterized adverse reactions for all products.ICSRs involving products suspected medicine in VigiBase between 1968 and 2021 were extracted. MedDRA preferred terms International Society Blood Transfusion haemovigilance definitions used stratify reactions. Descriptive...
The online workshop on IVD regulation was performed to broaden the understanding of technical documentation needed for licensing and strategies asses it.Testing blood donors donations significantly reduces risk transmitting transfusion-transmissible infections. Many test systems are commercially available, but not all meet recommended sensitivity specificity standards. African countries either lack functional structures IVDs this poses a threat quality supply.The Paul-Ehrlich-Institut...
During the training workshop on Inspection of Blood Establishments, which was hosted by PEI GHPP BloodTrain in Harare from 20th to 24th May 2019, participants National Regulatory Authorities seven Sub-Sahara African countries presented their current experiences related regulation and inspection blood establishments respective countries. While all conventional medicinal products manufacturer is performed, regulatory situation components as well still heterogeneous.
According to the World Health Organization, blood must be screened for major transmitted infections before transfusion prevent possibility of passing an infection recipient. For accurate detection infectious disease pathogens in donors, in-vitro diagnostic medical devices (IVDs) high specificity and sensitivity should used. In mature healthcare systems, regulatory authorities authorize usage with highest performance capabilities, which are also controlled through active market oversight....
The training workshop on Implementation of Blood and Product Regulation was organised co-hosted by the Paul-Ehrlich -Institut Global Health Protection Program BloodTrain Africa Society for Transfusion (AfSBT) from 20th to 22nd August 2019. This aimed at strengthening capacity African countries in developing implementing regulatory systems blood. Over thirty participants across continent came together Johannesburg, South shared knowledge experiences among themselves also with experts...
Abstract Background: Haemovigilance is an important element of blood regulation. It includes collecting and evaluating information on adverse events resulting from the use components with aim to improve donor patient safety. We assessed how haemovigilance currently being implemented performed in 10 sub-Saharan African countries. Methods :We piloted integrated WHO Global Benchmarking Tool plus Blood (GBT+ Blood) assess function national regulatory authorities (NRAs) Ethiopia, Kenya, Malawi,...