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ORCA 2008 Schedule of Meetings
Date of Last Update: May 25, 2008
January 16, 2008
Topic: Clinical Trial Updates: Critical Changes in US and EU Regulations and Guidance
Speaker: Kirsten Vadheim, PhD, RAC; Biomedical Compliance Consultant
Location: Zymogenetics, Seattle
February 13, 2008
Topic: Non-Clinical Development Considerations
Speaker: Brian Baker, SNBL
Location: Monte Villa Office Park Barn, Bothell
March 20, 2008
Topic: Cellular Therapy: Graft Engineering, Process Development, Clinical Studies, and Regulatory Issues
Speaker: Shelly Heimfeld, PhD, Fred Hutchinson Cancer Research Center
Location: Silver Cloud Inn, Lake Union, Seattle
April 9, 2008
Topic: Commercialization and Reimbursement of Prescription Products
Speaker: Linda L. Schock, CV Therapeutics, and Richard (Dick) W. Rylander, Jr., BioPharmaceutical Strategies, LLC
Location: Talaris Conference Center, Seattle
May 14, 2008
Topic: Audio Conference, Medical Device Compliance Topic
Speaker: Kim Trautman, FDA
Location: Lake Washington Technical College, Redmond
June 6, 2008
Topic: Phase 1 Studies - Safety and Design (1/2 day seminar)
Speaker: Martha Feldman, Drug & Device Development Co., Inc
Location: Ray's Boathouse Restaurant, Seattle
July 16, 2008
Topic: FDA Regional Updates
Speaker: Charles M. Breen, FDA Seattle District Director
Location: Lake Washington Technical College, Kirkland
August 6, 2008
Topic: LEARN Six Sigma
Speaker: Achim Reeb, PROsys NW LLC
Location: Talaris Conference Center, Seattle
September 25, 2008
Topic: Annual Meeting
Facilitating Speaker: Jary Krauser
Speaker: Bruce Carter, CEO Zymogenetics
Location: Woodmark Hotel
October 8, 2008
Topic: "Update on Pharmaceuticals and Medical Devices in Europe"
Speaker: Dr. Michael Rinck
Location: Talaris Conference Center, Seattle
November 5, 2008
Topic: "Revised prescribing information for pharmaceutical products"
Speaker: Joyce Chiarenza
Location: Talaris Conference Center, Seattle
December 2008
No meeting, Happy Holidays!
Meeting Notices are posted on this website when date, time, speaker,
topic, and location are finalized.
Attendance at meetings may be used as credit towards RAC recertification.
For additional informationor to be added to the ORCA meeting notice email
distribution list, please contact:
Organization of Regulatory & Clinical Associates
P.O. Box 3490
Redmond, WA 98073-3490
Phone: (206) 464-0825
E-mail: info@orcanw.org
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