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The Management of Clinical Trials - GMP Meets GCP
27-28 November 2008
Prague, Czech Republic
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Objectives
During this course, specialists from the pharmaceutical industry and the regulatory authority share their expert knowledge about important aspects of IMP Supplies and the Management of Clinical Trials. Hear essential aspects about the organisation and management of the supplies, their distribution, things to consider during the study and learn how the various regulations lead the way. During this conference, the important interfaces between GMP and GCP will be elaborated.
Background
In the development of new pharmaceutical products, it is a challenge to design and initiate sound and appropriate studies. Compliance with GMP and GCP regulations is mandatory.
A prerequisite for a successful study is the thorough planning of the clinical trial supplies. Beginning with the order, the manufacturing and supply of the IMPs, an efficient study management and full compliance with applicable rules and regulation lead to satisfactory results. An area where requirements of both GMP and GCP requirements need to be considered and understood from all parties involved. A fact which is often not the case.
Trials outside the EU and suspected misconduct and fraud are two other aspects which require particular attention.
This conference has been designed by the ECA to enhance and broaden your knowledge and to consolidate the various aspects which need to be taken into account for an efficient management of clinical trials.
Background
In the development of new pharmaceutical products, it is a challenge to design and initiate sound and appropriate studies. Compliance with GMP and GCP regulations is mandatory. Trials outside the EU and suspected misconduct and fraud are just two aspects which require particular attention.
A prerequisite for a successful study is the thorough planning of the clinical trial supplies. Beginning with the order, the manufacturing and supply of the IMPs, an efficient study management and full compliance with applicable rules and regulation lead to satisfactory results. An area where requirements of both GMP and GCP requirements need to be considered and understood from all parties involved. A fact which is often not the case.
This conference has been designed by the ECA to enhance and broaden your knowledge and to consolidate the various aspects which need to be taken into account for an efficient management of clinical trials
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