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GLP Study Director

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Overview / Abstract:

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

Course 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 presenter recognizes 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.


May 31, 2018


Education (Higher Ed)


Live / Seminar, Seminar



Credits / Hours

1.2 CEUs



Presenters / Authors / Faculty

David Long; Long and Associates International Consulting Ltd.

Keywords / Search Terms

CfPA Study Director, GLP, Preclinical Regulatory R&D, OECD, monographs, compliance, problem solving, compliant, workshop Seminar CE CME

LIVE Activity Location Details

05-30-2018 - 05-31-2018

Amsterdam, The Netherlands

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