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

Overview

Sunday, June 8, 2008:	Registration & Evening Wine & Cheese Reception
Monday, June 9, 2008:	Day 1: The Principles of Study Directing (full day) Evening: Group Dinner
Tuesday, June 10, 2008:	Day 2: The Practice of Study Directing (full day) Evening: Free
Wednesday, June 11, 2008:	Day 3: Customer Feedback & Graduation (half-day)
	Post-workshop Bonus Session: Clin Path Data Crunch (Wed afternoon - Registration separate, but no additional fees)

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8:00 – 8:30 am	Welcome and Introduction to Workshop, Topics, and Speakers John Kapeghian (Preclinical Safety Associates)
8:30 – 9:15 am	It All Starts and Ends Here: Good Laboratory Practices Kirk Huber (Johnson & Johnson)
9:15 – 10:00 am	The Architecture of a Nonclinical Toxicology Study Mark Walker (Charles River)
10:00 – 10:15 am	Break
10:15 – 11:00 am	Protocol Development: Why can’t we get it right the first time? Fred Kirchner (Covance)
11:00- 11:45 am	Analytical & Bioanalytical: What is it we really need? Mike Schlosser (Midwest BioResearch)
11:45 – 12:30 pm	Study Management: The study is underway…..now what?? Darren Warren (SNBL)
12:30 – 1:30 pm	Lunch (Breaks & lunch sponsored by Midwest BioResearch)
1:30 – 2:15 pm	Clinical Pathology– Do you really need a clinical pathologist Glenn Elliott (Charles River)
2:15 – 3:00 pm	Anatomic Pathology: The good, the bad, and the really ugly Mark Butt (Tox Path Specialists)
3:00 – 3:30 pm	Break
3:30 – 4:15 pm	Pharmacokinetics: Why do people think this stuff is boring? Jerry Galluppi (Biogen Idec)
4:15 – 5:00 pm	The Report: Basic construction and common sense Doug Kornbrust (Preclinsight)
5:00 – 5:45 pm	You've heard it all, now here's what can still go wrong Laura Andrews (Genzyme)

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8:00 - 8:20 am	Introduction to Day 2: Bring on the data! John Kapeghian (Preclinical Safety Associates)
8:20 - 9:40 am	Data Interpretation: The ins and outs and sideways of getting it right Doug Kornbrust (Preclinsight)
9:40 - 10:00 am	Break
10:00 - 10:45 am	Safety Pharmacology & Reprotox Data - Are these really special cases? Debra Kirchner (Covance)
10:45 - 11:45 am	Clinical and Anatomic Path: The nuances are critical Glenn Elliott (Charles River)/Mark Butt (Tox Path Specialists)
11:45 - 12:20 pm	Putting it All Together: The art form of effective presentation of study findings Doug Kornbrust (Preclinical Insight)
	Faculty participation and discussion - this is an interactive forum.
12:20 - 2:00 pm	Lunch (Lunch sponsored by SNBL USA)
2:00 - 5:00 pm	Data Review Workshop: Examples of interesting data sets and interactive discussion about interpretation and reporting Doug Kornbrust (Preclinical Insight)/Glenn Elliott (Charles River)

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8:00 - 8:45 am	View from the Rear: What a Study Monitor Expects Steve Snyder (Outsource Support)
8:45 - 9:30 am	"And Now, a Word from our Management": Pharma management concerns, expectations of their study directors - are there really any differences? Jeff Hazelette (Novartis)
9:30 - 10:30 am	Your "other boss": How an FDA reviewer reads your reports Melanie Hartsough (Biologics Consulting Group)
10:30 - 10:50 am	Break
10:50 am - noon	Awards Ceremony & Workshop Closing
noon - 1:00 pm	Lunch (Lunch sponsored by Charles River)

Post Workshop MINI-Tutorial!!! (1:00-4:00 pm)
"Simplified Clin Path Data Crunch Program for Study Directors"
Glenn Elliot (Charles River)

Note: Registration for the MINI-tutorial is separate, but no additional fee for this program