STUDY DIRECTING: PRINCIPLES & PRACTICE 2008
June 8 – 11, 2008
Lake Tahoe, Nevada/California

Industry convention and governmental regulations dictate that the Study Director holds primary responsibility over all aspects of nonclinical study conduct and reporting, and it is well recognized that the expertise of the Study Director is the most important determinant of a successful study outcome.  Hence, proper training of study directors is crucial to enable optimal performance in this pivotal role.   Although many companies have developed some type of development tract for study directors, this most often takes the form of a graduated “hands-on” approach, rather than an intensive and effective training program.  Probably the main reason for the rather diffuse training is that the more experienced scientists are too busy to devote sufficient time for mentoring.

Thus, it appears that the industry would benefit from a concentrated training program for study directors, and the sponsors of the course described below have put together an excellent program to address this unmet need.   This program is specifically tailored for study directors within both the pharma and contract research industries and provides comprehensive training in all aspects of study directing.  The program consists of a two- and a half-day workshop, with lectures on basic principles on Day 1, real-time data interpretation and report presentation on Day 2, and feedback from your ultimate boss (you know who) on Day 3.  The world’s experts from pharma and CROs, as well as several independent consultants, have been assembled to teach the fundamentals of study directing from a regulatory and scientific perspective.

The course will be held at the fabulous Lake Tahoe Embassy Suites resort, and a block of rooms at a discount rate have been made available.  By the end of the course, attendees will have enjoyed numerous hours of lecture material presented in a dynamic interactive fashion, as well as hands-on experience in real-life scenarios in data interpretation, integration and report writing.   There will also be opportunities to receive feedback from the “customers”, i.e., the pharma industry Sponsor (for CRO study directors), management expectations/concerns (for pharma in-house study directors). and last, but not least: regulatory agency representatives.

The networking opportunities at the various refreshment breaks, meals and off-site activities are designed for further mentoring and learning, in addition to making the whole experience quite enjoyable.

There is nothing else of this scope offered within the industry.  It’s time to sign up your study directors for focused training in their craft.  

Reserve your "slot" today.  Enrollment will be limited, to allow individual attention throughout the course.

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Course Organized & Sponsored by:  
Preclinical Safety Associates & Preclinsight
(Toxicology & Preclinical Safety Consulting)

Workshop Leaders:  John Kapeghian & Doug Kornbrust