GLP Study Director
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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.