Hotel Information:
Hyatt Arlington
Hyatt Arlington
1325 Wilson Boulevard
Arlington, VA 22209
(703) 525-1234
Rate: $
239
Deadline for Group Rate:
2010-08-14
Hotel Policy
|
Registration Rate:
$1,495.00 Register by 09/13/10
$1,695.00 Register after 09/13/10
Cancellation Date: 9/18/10 (Cancellation fee is determined by date cancelled.)
Register Now
Registration Policy
Continuing Education Credit:
ACPE:
0708-0000-10-022-L03-P (1.4 CEU)
Initial Release Date:
9/27/10
CBRN:
N/A
CME:
14 Hours of Category 1 Credit
VNA:
07-04-01 14 Contact Hours
Continuing Education Policy
|
| |
Course Description:
This course will be held at:
The PERI Training Facility
1616 N Fort Myer Drive Suite 1430
Arlington, VA 22209
Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 5:00 PM
This course is recommended for Good Clinical Practices (GCPs) professionals with at least five years experience. This course builds on the basic GCP training with a focus on GCP auditing techniques and strategies. The course provides an advanced in-depth, application-oriented training delivered by faculty members who have extensive experience in the GCP arena.
|
Who Should Attend:
This course will be extremely valuable for regulatory managers, compliance auditors, QA managers, clinical investigators, academic research directors and clinical coordinators/monitors.
|
Educational Objectives:
Upon completion of this course, participants should be able to:
•Upon completion of this course, participants should be able to:
• Establish effective relationships with stake holders to insure productive clinical trial management
• Analyze complex auditing situations, including systems auditing, and report findings/action plans to senior management.
• Evaluate initial and ongoing relationships with CROs
• Describe opportunities and challenges of conducting international trials
|
Key Topics:
•Overview of the FDA
•Assessment of Clinical Data
•Conducting Clinical Trials in Developing Countries
•Contract Research Organization and Partnership Evaluations
•Beyond the Regulations: GCP Challenges
•FDA¿s Division of Scientific Investigations (DSI) Update
•The Value in the Vision: Future Role of Regulatory Compliance Professionals
•Fraud/Scientific Misconduct and Case Histories
•Electronic Records at Clinical Sites
•Overview of Computer Technology in Auditing
•Ethics, Conflicts of Interest, and Informed Consent
|
Course Director(s):
Kathleen A. Moran, MS
Head of Quality, Research and Development
GE Healthcare
For a complete list of faculty or an agenda, please contact the course manager.
|
|
Contact Course Manager:
Course Manager
|
| |
|
Print Friendly PDF
|
|
PERI reserves the right to change agenda
items and instructors without notice to accommodate
situations beyond its control.
|
