GCP training course: Good Clinical Practice

10.10.2013

Please login using the 6th October 2013, the number of places is limited.

Programme

Thursday
13:00

GCP Creation, Principles and Development

Thursday
13:20

Phases of Drug Development, Methodology of Clinical Studies

Thursday
14:00

Legislation of Clinical Trials

Thursday
14:40

Centre Selection

Thursday
15:00

Investigator’s Roles and Duties (Informed Consent)

Thursday
15:20

Source Data and Source Documents, Coordinator’s Role, AE, SAE and their Reports - Casuistry

Thursday
16:30

Dealing with the Assessed Drug

Thursday
16:50

Monitoring of the Study, Audit and Inspections

Thursday
17:20

Casuistry topic “coordination of the centre – monitor - sponsor“

Thursday
18:10

End of course

Lecturer

M.D. Mgr. Karel Šlais, Ph.D.

M.D. Mgr. Karel Šlais, Ph.D.

Faculty of Medicine of Masaryk University

MUDr. Josef Bíma

MUDr. Josef Bíma

Parexel

M.D. Radka Obermannová

M.D. Radka Obermannová

Faculty of Medicine of Masaryk University, Masaryk Memorial Cancer Institute

MVDr. Renata Horová

MVDr. Renata Horová

Masaryk Memorial Cancer Institute

Mgr. Michaela Hanáková

Mgr. Michaela Hanáková

Masaryk Memorial Cancer Institute

Bc. Jana Haičmanová

Bc. Jana Haičmanová

Masaryk Memorial Cancer Institute

Mgr. Roman Goněc

Mgr. Roman Goněc

Masaryk Memorial Cancer Institute

Fee

The course is free.

The training is designed for investigators, examiners, studio, studio coordinator and nurses.
Boardroom č.432, LF MU campus, pavilions A17, 4.NP Kamenice 5, Brno.

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