The Center for Professional Advancement, New Brunswick, NJ
October 22-24, 2007
Who Should Attend:
This course is designed for those who already have some experience in managing GLP studies; those who wish to extend their role to study direction and their competence in study management, particularly in the complex multi-site environment. The course will benefit the following individuals:Existing Study Directors who wish to upgrade their competence in a multi-site situation
The newly appointed Study Director
Study supervisors who wish to become Study Directors
Study Monitors
Principal Investigators in the field of preclinical regulatory R&D
Coordinators of multi-site projects
Description:
The current regulatory environment imposes far reaching responsibilities on Study Directors and Principal Investigators in preclinical regulatory R&D. This course takes as reference the GLP regulations of the FDA and OECD and the associated OECD interpretive monographs particularly on study direction, sponsor responsibilities and multi-site studies. Dealing with the increased range of duties and responsibilities of study managers is the core issue of this course. This course goes further than just presenting the theoretical roles of study managers in the difficult arena of multi-site studies. A strong feature of this course is the high level of interactive, dynamic problem solving situations that the participants are asked to resolve appropriately and speedily. The strategies available for managing compliant studies are given topmost priority. The presenters recognize that many courses can provide information, but information can only be turned into knowledge through the depth of understanding that comes from sharing experience and exchanging ideas. This is why a workshop approach is so valuable.
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