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.
The course goes further than presenting the theoretical roles of
study managers in the difficult arena of multi-site studies. The
workshop based activities address the practical aspects of study
direction and investigate possible solutions to ensure full
compliance.
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.