Hotel Information:
Hyatt Arlington
Hyatt Arlington
1325 Wilson Boulevard
Arlington, VA 22209
(703) 525-1234
Rate: $
239
Deadline for Group Rate:
2010-01-16
Hotel Policy
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Registration Rate:
$1,495.00 Register by 06/6/10
$1,695.00 Register after 06/6/10
Cancellation Date: 7/12/10 (Cancellation fee is determined by date cancelled.)
Course Completed
Registration Policy
Continuing Education Credit:
ACPE:
0708-0000-10-020-L03-P (1.4 CEU)
Initial Release Date:
7/21/10
CBRN:
N/A
CME:
14 Hours of Category 1 Credit
VNA:
07-04-01 14 Contact Hours
Continuing Education Policy
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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 - 4:30 PM
FDA FACULTY CONFIRMED
This course will provide an overview of key issues in the development of pediatric drug development. Experts from the industry, FDA and academia will address issues including but not limited to pediatric vs. adult clinical trials; regulatory considerations; ethics; design of pediatric clinical trials, statistical consideration in trial design, and patient recruitment and retention.
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Who Should Attend:
This course is directed towards professionals involved in pediatric clinical trials and affiliated with pharmaceutical and biotech companies; academic and government institutions and contract research organizations. This includes clinicians, project planners, monitors, nurses, physician assistants and regulatory professionals who could benefit from a review of recent advances and progress in the field.
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Educational Objectives:
Upon completion of this course, participants should be able to:
•Identify key anatomical/physiological differences between adults and children
•Describe clinical lab values in children.
•Discuss the uniqueness of pediatric clinical pharmacology (i.e. drug metabolism)
•Identify unique aspects of pediatric clinical trials and incorporate these aspects into trial design
•Create successful pediatric IRB submissions
•Identify key attributes of a good pediatric CRO
•Develop recruitment and retention plans for pediatric trials
•Recognize differences between EU and US pediatric drug development
•Identify FDA¿s requirements of a written request
•Name pediatric sites and networks that can assist with studies in pediatric subjects
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Key Topics:
•Anatomy and Physiology of Children
•Biochemistry from Neonate to Adolescent
•Uniqueness of Clinical Pharmacology in Pediatrics
•Designing Clinical Trials for Children
•Getting the Outcome Measures Right
•Developing Age-Appropriate Formulations
•Bioethical Issues
•The Successful IRB Submission
•Regulations for Pediatric Drug Development
•Recruitment and Retention
•Clinical Operations - Considerations for Functional Pediatric Clinical Trials
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Course Director(s):
Ernest A Kopecky, PhD, MBA
Head, Pain and Neuroscience, Clinical Research and Development
Endo Pharmaceuticals, Inc.
For a complete list of faculty or an agenda, please contact the course manager.
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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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