Clinical Research 101
Clinical Studies SIG
2/17/2010 |
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Time
Registration: 7:30 am - 8:00 am
Program: 8:00 am - 4:15 pm
Event Description
This program will provide a comprehensive introduction to clinical research. It is designed for those who are new to the medical device and/or diagnostic product industry, or who work in conjunction with this area and want to learn more about it. It will serve as a refresher course for those who may be working with new products or in new areas of responsibility, and a foundation for those working within other disciplines.
View the Program Agenda
At the end of the Clinical Research 101 seminar, attendees will:
• Have a basic understanding of GCPs and why we need them
• Outline key sections of a clinical study protocol
• Understand the process of informed consent
• Understand the key considerations for adverse events and protocol deviations
• Have an understanding of clinical site selection and center activation issues
• Know what documents to review when monitoring a clinical study
The agenda includes the following topics:
• Good Clinical Practices (GCPs)
• Clinical Study Site Selection & Center Activation
• Site Management and Study Close-out
• Informed Consent Rules for Clinical Trials
• Adverse Events and Protocol Deviations
• Protocols: Thoughtful Planning for Successful Trials
Speakers
Debbi Lindgren-Clendenen, APRN-BC, GNP; Cassie Jacobson, Clinical Research Manager, 3M; Sarah E. Moeller, M.S., Chief Executive Officer, The Greenlight Group, LLC; Lynne M. Rasmussen, Attorney, Law Offices of Lynne M. Rasmussen, PLLC; Kimberly A. Oleson, Senior Director, Medtronic, Inc.; Nancy Drake, Principal Project Manager, Alquest, Inc.
Debbi Lindgren-Clendenen, APRN-BC, GNP is a currently an independent consultant in clinical research. She was previously Medical Advisor at a local CRO. Deb has over 18 years of experience in (more)
Cassie Jacobson is currently a Clinical Research Manager in 3M's Medical Division, and has been with the group for 10 years working on a variety of non-significant (more)
Sarah E. Moeller, M.S. has 15 years' experience designing, monitoring, and auditing global device and pharmaceutical clinical trials. She has extensive project management (more)
Lynne M. Rasmussen began her career handling commercial litigation matters for a variety of clients, first with Sheppard, Mullin, Richter & Hampton LLP in Los Angeles (more)
Kimberly A. Oleson is the Senior Director for Medtronic Ventures & New Therapies located in Minneapolis, Minnesota. Kimberly is responsible for the strategic leadership (more)
Nancy Drake is a Principal Project Manager at Alquest, Inc. a Minneapolis-based medical device CRO. She has more than 30 years of experience in research (more)
Topics
The following topics will be addressed:
Location
DoubleTree Park Place Hotel - 1500 Park Place Blvd., St. Louis Park, MN 55416 -- 952.542.8600 for front desk. Directions: Hwy. 394 to Park Place/Xenia exit - south to 16th St. - right on the corner.