Kalendarium

Miejsce:
Koszt: 1397 PLN za udział jednej osoby / 370 EUR per person
UWAGA! Dla uczestników poprzednich szk
Kontakt:
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tel: null
e-mail: szkolenia@biotechnologia.pl
Preliminary synopsis

One-day training is supposed. The main goal is to learn basic principles of preclinical toxicology, its role in the process of new pharmaceuticals development, the role of European legislation and regulation in this process, basic principles of animal experiments involved in preclinical stage of pharmaceutical development and practical experience of preclinical CRO.

Main topics:

9.30-10.00	Registration and coffee
10.00-11.30	I. Role of preclinical toxicology in the process of pharmaceutical development     a) Phases of the drug development     b) Relevant legislation     c) Preclinical requirements for individual phases of the drug development
11.30-11.45	Break
11.45-13.15	II. Preclinical studies I     a) Test system, test item, application formulation     b) Characterization of individual types of preclinical studies I (short term studies)
13.15-14.15	Lunch
14.15-15.45	III. Preclinical studies II     a) Characterization of individual types of preclinical studies I (long term studies)     b) Bioavailability, TK/PK, ADME
15.45-16.00	Break
16.00-17.30	IV. Practical experience     a) The role of Quality Assurance Unit     b) Chronic toxicological study in non-human primates from the Study director point of view     c) BioTest s.r.o, the preclinical CRO: capability, certification and practical experience
17.30	Close of meeting

Facilitators

Ivana Šurova, MSc
Dr. Ivana Šurova has over 20 years experience in preclinical toxicology, especially in clinical pathology. She has worked as Head of Laboratory of Hematology and biochemistry at Research Institute for Pharmacy and Biochemistry and later at BioTest s.r.o. She has worked as Study director for acute, sub chronic and chronic toxicological studies in rodents and non-rodents. Since 2004, she has worked as Project manager at BioTest s.r.o. and external expert for preclinical evaluation at State Institute of Drug Control, Prague. She holds a degree in biochemistry from Faculty of Medical Biology, the 2nd Medical Institute Moscow. Since 2006, she works as Head of business Department at BioTest s.r.o.


Aleš Brejcha, PhD

Dr. Aleš Brejcha has over 25 years of experience in toxicological pathology and general toxicology, designing and evaluation of toxicological studies. He has conducted and supervised many preclinical toxicological studies and at the same time, he has worked as an expert in toxicological pathology. Since 2004, he has worked as external expert for preclinical evaluation at State Institute of Drug Control, Prague. Since 2006, he leads the Laboratory of Pathology and Histopathology at BioTest s.r.o. He holds a degree in pharmacology from Charles University Hradec Kralove, the Czech Republic.


Jiří Marhan, PhD

Dr. Jiří Marhan has long-term experience in microbiology and genetic toxicology. Since 1994, he has worked as the head of Microbiology Department at Research Institute for Pharmacy and Biochemistry Prague, branch Pardubice. Since 1999 participated in the activities of the quality assurance system, since 2006 works as the head of Quality Assurance Unit at BioTest s.r.o. At the same time participates in educational activities concerning preclinical toxicology and quality assurance system. He holds a degree in microbiology from Masaryk University Brno and Czech Academy of Sciences, Prague.



Martin Šlais, MSc

Mgr. Martin Šlais has worked as Assistant at Hydrobiology Institute of Czech Academy of Science,  České Budějovice and since 2003 as the Head of Laboratory of Ecotoxicology at  BioTest s.r.o. Since 2005 he attends PhD degree studies at Faculty of  Veterinary  Hygiene and  Ecology, Veterinary and Pharmaceutical University Brno. He has experience in preclinical toxicology especially pointed to preclinical evaluation of vaccines. He works as scientific head of preclinical part of several grant projects covered by   6th and 7th EU Frame Program. Since 2007 he works as a Head of Department of toxicology at BioTest  s.r.o.                               .



FORMULARZ ZGŁOSZENIOWY/ REGISTRATION FORM


Time and pleaces training:
20^th January, 2009
Cracow, Poland
Hotel Alexander
Garbarska 18 Street

Training cost:
* 1397 PLN
* 370 EUR

Training cost include:
* training participation,
* lunch,
* free break,
* training materials,
* participation certyficate.

Kontakt:
Bio-Tech Consulting Sp. zo.o.
Mateusz Marek
ul. Kamińskiego 23
90-229 Łódź, Poland
Tel. (42) 678-01-12
Fax (42) 678-01-28