Hotel Information:
Hyatt Arlington
1325 Wilson Blvd
Arlington, VA 22209
703-525-1234
Rate: $
259
Deadline for Group Rate:
2009-04-20
Hotel Policy
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Registration Rate:
$1,495.00 Register by 04/17/09
$1,695.00 Register after 04/17/09
Cancellation Date: 5/1/09 (Cancellation fee is determined by date cancelled.)
Course Completed
Registration Policy
Continuing Education Credit:
ACPE:
708-000-07-037-L03 (1.875 CEU)
Initial Release Date:
4/23/07
CBRN:
N/A
CME:
18.75 Hours of Category 1 Credit
VNA:
07-04-01 18.75 Contact Hours
Continuing Education Policy
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Course Description:
This course is being held at:
The PERI Training Facility
1616 N Fort Myer Drive, Suite 1430
Arlington, VA 22209
Day 1 8:00AM – 5:00PM
Day 2 8:00AM – 5:15PM
Day 3 8:00AM – 12:00PM
This course provides an overview of the clinical trial process with particular emphasis on planning and management. A balanced presentation of process and opportunity for detailed discussion and networking will address specific situations that impact efficiency, cost, and study completion. Interactive sessions serve as the basis for thoughtful analysis of how to design effective and efficient studies.
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Who Should Attend:
This course is intended primarily for those involved in planning and management of multiple clinical trials. Team members who should attend include clinical research associates, study coordinators, medical program coordinators, clinical research managers, clinical affairs specialist, project managers, medical services managers, medical research associates, clinical/principal investigators, and clinical/medical monitors.
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Educational Objectives:
Upon completion of this course, participants should be able to:
Describe the principles and processes related to clinical trial effectiveness
List essential elements of protocol development
Identify effective patient recruitment resources
Assess staff and outsourcing needs to meet the changing needs of clinical trial management
Manage sponsor-CRO relations more effectively
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Key Topics:
Key Success Factors in Managing Clinical Trials
The Drug Development Process
Developing Safe, Effective and Efficient Biologics
The Clinical Trial Checklist
Project Management
Study Recruitment and Working with Sites
Investigators’ Meetings
Institutional Review Boards (IRBs)
Managing Outsourcing
Case Report Form Development
Data Collection and Electronic Data Capture
Drug Development Workshop
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Course Director(s):
Ira Spector, MBA
Vice President Clinical Development Operations and Vice Chief of Operations
Wyeth Research
&
Wilson Bryan, MD
Senior Consultant
Biologics Consulting Group
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Contact Course Manager:
Course Manager
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PERI reserves the right to change agenda
items and instructors without notice to accommodate
situations beyond its control.
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