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CfPA - The Center for Professional Advancement, New Brunswick, NJ
October 9-10, 2013
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 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.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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David Long; Long & Associates International Consultancy Ltd.
David Long worked for Rhône Poulenc Health Division (now Sanofi-Aventis) in Quality Assurance (QA) for over twenty years where he gained considerable experience in all three Good Practice disciplines, GLP, GCP and GMP. When he left Rhône-Poulenc he was Senior Director R&D Worldwide for Quality and for Process Improvement. Mr. Long has since worked for CHIMEX, a manufacturing subsidiary of the L'Oreal group, and also runs his own consultancy company.
Mr. Long has always shown a keen interest in promoting professional QA activities. He was a founder member and President of the French QA Society and a founder member and President of the European QA Federation. He was also the founder and Chief Editor of the Quality Assurance Journal, an international scientific journal specifically addressing subjects of interest to the R&D QA personnel.
He has lectured and trained widely, and been an active participant in developing training in Good Practices and QA working with a number of international groups including the OECD and the WHO. His latest contribution through the WHO has been in the co-authoring of a set of guidelines for research performed upstream of the regulatory scene, called "Quality Practices in Basic Biomedical Research".
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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