STUDY DIRECTING: PRINCIPLES & PRACTICE 2008

June 8 – 11, 2008: Embassy Suites Lake Tahoe Hotel & Ski Resort

About “Study Directing: Principles & Practice”
This is a “first-of-its-kind”, 2 ½ day workshop focused on the regulatory, scientific and practical aspects of the role of the Study Director in preclinical testing.  Faculty from the pharmaceutical industry, contract research organizations, and independent consultants with expertise in Toxicology, Clinical and Anatomic Pathology, Pharmacokinetics, Bioanalytics, GLP compliance, Data Review, Report Preparation, and other key skills vital for today’s Study Director, will present course material and assist in the hands-on data evaluation sessions. (more...)

Course Structure includes:

• Day 1 – Lecture and panel discussion on all key topics
• Day 2 – “How – to” – data review and report preparation: hands-on training
• Day 3 – Feedback from management, sponsor, and the FDA ( ½ day )
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Upon graduation the attendees will:

• Have completed ~12 hours of lecture covering pertinent topics from experts in the field
• Have completed ~8 hours of interactive data evaluation and report writing training
• Networked with colleagues and faculty at breaks and course events – crucial to training
• Understand regulatory compliance and know how to deal with current issues
• Know how all the components of a GLP study fit together to support safety evaluation
• Gained the perspective of the sponsor, management, and regulatory agency reviewer

• Registration:                 $1,595 
• Group registration:       $100 discount per registration for 2
                       $200 discount per registration for 3 or more