European Union pharmacovigilance capabilities : potential for the new legislation

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed.peer-reviewe

Cross-affinity of peptide ligands selected from phage display library against pancreatic phospholipase A2 and ammodytoxin C

Two phage-displayed random peptide libraries were screened for ligands with potential inhibitory activity against pancreatic phospolipase A2 or ammodytoxin C (neurotoxin found in the venom glands of Vipera ammodytes ammodytes). The interaction of selected peptides with pancreatic phospholipase A2 and ammodytoxin C was confirmed with surface plasmon resonance and phage ELISA assays. Interestingly, peptides showed equal affinity to both proteins, regardless which of the two proteins was used as a target in the selection procedure. Despite pronounced affinity, none of the synthetic peptides inhibited enzyme targets in vitro at the concentrations below 167 [micro]M.Pri iskanju ligandov s potencialno inhibitorno aktivnostjo na pankresno fosfolipazo A2 ali amoditoksin C (nevrotoksin iz strupnih žlez modrasa Vipera ammodytes ammodytes) smo uporabili dve knjižnici naključnih peptidov, izraženih na bakteriofagih. Peptidi, ki smo jih selekcionirali z različnimi selekcijskimi protokoli, jasno kažejo afiniteto do pankreasne fosfolipaze in amoditoksina C, ki smo jo določili s pomočjo površinske plazmonske resonance in encimskoimunskega testa. Peptidi presenetljivo izkazujejo podobno afiniteto do obeh proteinov, ne glede, katerega smo uporabili kot ciljno molekulo pri selekciji. Navkljub nedvoumni afiniteti, peptidi v območju testiranih koncentracij niso inhibirali fosfolipaznega delovanja in vitro