The Austrian Official Medicines Control Laboratory (AGES OMCL) is member of the European Network of Official Medicines control laboratories. The main task of an OMCL is quality control of medicinal products on the legal market.
The AGES OMCL is part of the business segment Austrian Medicines and Medical Devices Agency (AGES MEA) of the Austrian Agency for Health and Food Safety (AGES). Fully owned by the Republic of Austria, AGES MEA is responsible for a variety of tasks such as issuing marketing authorization for medicinal products (human and veterinary), assessing the efficacy and safety of medicinal products and medical devices, market surveillance and inspection of manufacturers.
Role of AGES in VAC2VAC
The AGES OMCL is mainly involved in the development of immunological assays for the consistency testing of vaccines. The main goal for the AGES OMCL within this project is the reduction, refinement and replacement of in vivo testing. The development of alternative, substitute and complementary assays will ensure the safety and efficacy of vaccines in the absence of in vivo tests. Additionally, the AGES OMCL will help to design and participate in collaborative studies to improve the acceptance of alternative methods.
Dieter Pullirsch is the coordinator of the Expert Group 'Vaccines and Plasma Pool Testing' within the AGES OMCL and he is expert in the European Pharmacopoeia Group of Experts 15V - Veterinary Vaccines and Sera.
Heidemarie Schindl is Head of the Department 'Analytics of Biological Medicinal Products' and she is an expert in the European Pharmacopoeia Group of Experts 15 - Human Vaccines and Sera.