Course No 16588
|Non-ECA Members:||EUR 1990,--|
|ECA Members:||EUR 1790,--|
|EU GMP Inspectorates:||EUR 995,--|
|APIC Members (does not include ECA membership):||EUR 1890,--|
|QP Association Members:||EUR 1790,--|
(All prices excl. VAT)
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During this course, well-experienced specialists will 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 event, the important interfaces between GMP and GCP will be elaborated.
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 will lead to satisfactory results. GMP and GCP requirements need to be considered and understood from all parties involved.
Trials outside the EU and contracts and agreements are two other aspects which require particular attention.
This event 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.
Specialists, managers and executives from R&D dealing with the various aspects of IMP supply and clinical trial management. It addresses representatives from IMP manufacturing, packaging, QP certification and supply as well as from the study design and management and the respective Quality Assurance units. It is also directed to CROs and members of inspectorates and authorities.
How things can go wrong
Interfaces between GMP and GCP
Clinical trials Phase I – III, Investigator-Initiated Trials and Pre-Approval Access to IMPs