Janka Jagelkova MSc
Graduated in 1963 at the Technical University, Faculty of Chemistry, Bratislava, specialising in technical microbiology and biochemistry. Achieved a PhD at the Medical Faculty University Košice and the Medical Faculty, Charles University, Prague. PhD thesis: NAD/NADH inhibitors creation in the coenzyme preparation as related to the effect of the clinical determination of LDH in human serum. PhD received in the year 1997.
Employed at the pharmaceutical company IMUNA, Šarišské Michaľany as a technologist, before being made the production department head, responsible for applied research.
Scope of work: Production and applied research of anti-tetanus serum vaccines on vitro diagnostics for the blood enzymes testing and the RM materials preparations for the clinical-biochemical laboratory efficiency testing, production and the solutions for kidney haemodialysis.
Employed at the State Institute for the Control of Drugs (SIDC)-Slovak Republic as a general inspector, as well as a specialised inspector for blood banks and the blood derivatives industry.
Scope of work:
GMP inspection of the pharmaceutical industry/drug distribution establishments, preparation and proposals of documents for the state legislation on drug control and inspection, preparation of SIDC for PIC/S membership (writing documents, communication with PIC inspectorates, participation on PIC training/activities).
Re- employed at SIDC since January 2003 as GMP Inspector
Scope of work:
Preparation of the scientific program and related documents for PIC/S meeting 2003 in Bratislava, including the training of GMP inspectors. Participation on the inspections executed by the EDQM/PIC/S and EMEA inspectors.
Since July 2008 – retired again
1993 Training at FDA-USA for the state regulatory processes focused on the state control and inspection of the pharmaceutical manufacturing, especially biologics (blood, blood derivatives, vaccines and medical devices) inspections.