BRFAA - Biomedical Research Foundation Academy Of Athens
Biomedical Research Foundation Academy Of AthensAcademy Of Athens

Drug Discovery - Drug Development

The Tamvakopoulos lab was established in 2004, and has been accredited by the Hellenic Accreditation System S.A. (E.SY.D) according to the standard "ΕΛΟΤ ΕΝ ISO/IEC 17025:2005" for the analysis of the peptide drug Leuprolide in human plasma, since 2008. Given the existing experience and infrastructures, the lab, which also operates according to Good Laboratory Practice (GLPs) guidelines, is now able to expand its Certificate of Accreditation for the quantitative measurement of any drug in biological fluids and tissues.

For the realization of this goal, the lab begun a collaboration with the company "Priority Quality Consultants", in February of 2007, towards the development of a quality system according to the standards of ISO 17025:2005. Funding for this effort became available from a Grant «ΑΚΜΩΝ» issued by the Greek General Secretariat for Research and Technology (Principal Investigator: Dr. P. Sideras, Co-Investigators: Dr. C. Tamvakopoulos and Dr. A. Andreakos).

For the purposes of the ISO, the lab was organized as follows: Head of Scientific Affairs: Dr. C. Tamvakopoulos, Quality Assurance Manager: A. Gaitanis, M.Sc., Analysts: C. Tamvakopoulos, Ph.D., T. Karampelas, Ph.D., P.Agrafiotou, PhD. Dr. Tamvakopoulos with extensive experience in bioanalytical and in pharmacokinetic/bioavailability studies, has assumed the responsibility that the lab will follow the ISO standards and will produce results of high integrity. Mr. A. Gaitanis (Head of Sector of Biomedical Technology-BRFAA) was selected and trained accordingly for the position of Quality Assurance Manager and with his additional experience is now able to consult and collaborate with other laboratories of BRFAA on quality management issues. All members of the laboratory have been trained extensively on issues regarding the application and philosophy of the ISO standard and in topics relative to drug bioanalysis using Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS).

The preparation of our laboratory for the accreditation was achieved in 8 stages, lasting 6 months in total: 1/ Diagnostic study, 2/ Initial training, 3/ Development of quality management system and organizational structure, 4/ Development of Standard Operational Procedures (S.O.P.s), 5/ Quality handbook, 6/ Training on the quality system, 7/ Testing of the quality system and 8/ Application Submission to the Hellenic Accreditation System S.A. The standard operating procedures we developed in the context of the preparation for the application included SOPs related to the evaluation of our suppliers and the receipt of consumables, to safety and hygiene, to the validation of analytical methods, to the assessment of uncertainty in measurements, and to the use, service and repair of scientific instrumentation. The Quality Management System is kept electronically using specifically designed software (e-Qual) which is consistent with the requirement of the ISO Standard for automatic registration of corrective actions and updates of existing protocols and procedures. Finally, all the laboratory equipment that is critical for the analysis (analytical balance, pipettes, solvent evaporation system, freezers, deep-freezers, thermometers etc.) has been certified by external experts or by our own Department of Biomedical Technology Management.

The application was submitted to E.SY.D. in July 2007. In November 2007 a pre-assessment was carried out by E.SY.D. inspectors that determined that the laboratory met the requirements of the ISO Standard and was allowed to proceed to the final audit/inspection, which took place in April of 2008. The Certificate of Accreditation was granted in October of 2008 and maintained ever since.

The capability given to our lab by this ISO Accreditation, is a key factor that will contribute significantly to the evaluation and development of novel or generic drugs.

Importantly, we have recently spearheaded a collaborative effort between the GLP certified pharmacology facility and an adjacent 30 bed clinical unit (part of Sotiria Hospital) for the execution of clinical trials (Phase I Unit), under the umbrella of BRFAA. This collaboration involves volunteer recruitment, drug design, sample collection, drug level measurements and statistical evaluation. Two CROs participate in the effort. Following drug dosing, pharmacokinetic and pharmacodynamic/biomarker (PK-PD) measurements will be performed in the BRFAA GLP laboratory.  This represents a unique opportunity in Greece that will allow the Biomedical Research Foundation of the Academy of Athens to participate in the process of developing generic drugs but of equal significance is our ongoing involvment in the evaluation of novel therapeutics. A formal meeting of the Clinical Trials initiative was held in BRFAA in October 2014 in which we presented our specific role and vision for this important objective

Dr. C. Tamvakopoulos
Head of Scientific Affairs

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Download ISO Accreditation Certificate for Pharmacology - Pharmacotechnology Division