Tomáš Hauser, MD (CZ)

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1.1.1. CZECH MEDICAL CHAMBER CERTIFICATES
Internal Medicine, 2001
Clinical Pharmacology, 2005

1.1.2. EDUCATION
M.D.
1990–1997 School of Medicine, Charles University, 120 00 Prague 2, Kateřinská 32, Czech Republic Graduated as a Doctor of Medicine (MUDr., M.D.) in 1997 Major: General Medicine

Resident
1997–2001 Postgraduate, Medical and Pharmaceutical Institute, 100 00 Prague 10, Ruská 85, Czech Republic. Major: Internal Medicine
Resident
2001-present Postgraduate, Medical and Pharmaceutical Institute, 100 00 Prague 10, Ruská 85, Czech Republic. Major: Clinical Pharmacology

1.1.3. POST GRADUATE EDUCATION AND TRAINING
1998,1999,20012002, 2003 Bio-equivalence studies seminar and training, Henry Stewart, conference studies
2001 Toxicological expert report seminar, Management forum Ltd., London
Since 2001 annually SUKl seminars on conducting clinical trials and relevant legislation 1988-present Consultation in dissolution testing Zentiva a.s., Analytical Department, Czech Republic
October 2006 Prof. Jim Maxon: Credible leadership program
May 2008 Couching for managers
October 2009 Workshop on Statistics for Bioequivalence organized by Helmut Shuetz (BEBAC)
Workshop on Dissolution testing and Biopharmaceutical classification system organized by J-M. Cardot

1.1.4. WORK EXPERIENCE
09/98–02/02 Clinical Manager at Leciva
02/02–02/03 Head of Clinical Documentation Department
03/03–12/03 Clinical Trials Manager at Zentiva
01/04–12/05 Corporate Clinical Trials Manager
01/06– 06/09 Medical Director of Clinical Research
07/09-present Clinical Development Director at Zentiva k.s., Prague, Czech Republic, with following responisibilites:
Management of therapeutic phase III studies, this included the design, medical writing and monitoring. Therapeutic areas: oncology, pain, osteology.
Managed more than 200 bio-equivalence studies including a modified release formulation.
Completed more than 120 clinical and toxicology expert reports, including portfolio up-dates entire dossiers as preparation for EU accession.
Responsible for the clinical and toxicological part of Zentiva’s registration dossiers and licensing in. Expert evaluator of dissolution testing and the in vitro in vivo correlation. Negotiation with EMEA, CEE and Russian Drug regulatory agencies in respect of clinical programs a regulatory requirements and scientific advice. Portfolio management and new products evaluation.
Feasibility of development projects.
1997–2001 Physician in clinical training General University Hospital, U Nemocnice 2, Prague Czech Republic
Interna co., Chittussiho 1, Prague 6, Czech Republic

1.1.5. MEMBERSHIPS
Czech Medical Society J.E. Purkyně
Czech Society of Pharmacology
Czech Society of Internal Medicine
Drug Information Association
EGA – Bioequivalence working group

1.1.6. PUBLICATIONS
Doležal T., Hauser T.: Bioekvivalenční studie s novými antihypertenzivy. Vnit.lék. 2005:51(1), 23–26.

1.1. 7 LECTURES
Highly variable drugs: view from industry. Symposium on Risk Analysis in Bio-equivalence Studies, Krakow, Poland, September 30 and October 1, 2008

1.1.8. OTHERS
2007 – international conference “CEE FORUM on BE-Studies”, Prague 2007, Main organizer