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.<br><br>
Dealing with the increased range of duties and responsibilities
of study managers is the core issue of this course.<br><br>
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.<br><br>
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.
01/01/0001
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Clinical Research Organization
Course Category
Address
Amsterdam
Amsterdam,