Session Information
2006 Midyear Clinical Meeting
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Managing Clinical Research and the Investigational Drug Service
Track:
Sessions
Program Code: 250-L04
Date: Tuesday, December 5, 2006
Time: 2:00 PM to 4:00 PM
Location:
213C (CC)
MODERATOR:
Kathy Diener Dasse, Pharm.D., BCOP, Safety and Risk Management Leader, Pfizer Global Research and Development, Ann Arbor, MI
SPEAKER(S):
Kathy Diener Dasse, Pharm.D., BCOP, Safety and Risk Management Leader, Pfizer Global Research and Development, Ann Arbor, MI
Recent Headlines in Clinical Research
Rivka Siden, Pharm.D., M.S., Clinical Assistant Professor, College of Pharmacy; and Clinical Pharmacist, Investigational Drug Service, University of Michigan College of Pharmacy, Ann Arbor
Tools for Dispensing and Accountability of Investigational Drugs
Helen R. Tamer, Pharm.D., Clinical Assistant Professor, College of Pharmacy; and Clinical Pharmacist, Investigational Drug Service, University of Michigan Health System, Ann Arbor
Issues Related to Dispensing Investigational Drugs
Description
Learning Objectives: Explain the potential implications of harm to subjects involved in clinical research. State when an investigator-related IND is needed for a clinical study. Describe practical problem-solving issues related to dispensing investigational drugs. Develop tools and systems to assure consistent record keeping and compliance with regulations.