Hotel Information:
Hyatt Arlington
Hyatt Arlington
1325 Wilson Boulevard
Arlington, VA 22209
(703) 525-1234
Rate: $
239
Deadline for Group Rate:
2010-02-06
Hotel Policy
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Registration Rate:
$1,495.00 Register by 02/6/10
$1,695.00 Register after 02/6/10
Cancellation Date: 3/12/10 (Cancellation fee is determined by date cancelled.)
Course Completed
Registration Policy
Continuing Education Credit:
ACPE:
0708-0000-10-001-L01-P (1.475 CEU)
Initial Release Date:
3/15/10
CBRN:
N/A
CME:
14.75 Hours of Category 1 Credit
VNA:
07-04-01 14.75 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 - 5:00 PM
This course will provide a comprehensive overview of asthma and COPD as a basis for developing new drugs to more effectively treat these diseases. A background on basic pulmonary physiology, standard approaches to pulmonary physiologic testing, current treatment approaches, and aerosol administration techniques will be provided. In addition, a review of regulatory policies in this area will be used to discuss recent approaches to developing new drugs for asthma and COPD.
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Who Should Attend:
This program is designed for anyone involved in the development of new drugs for asthma and COPD. Physicians, scientists, clinical research associates, product managers, marketing research analysts, statisticians and regulatory affairs personnel will find value in this course. This course is highly recommended for individuals who have recently moved or are moving to this therapeutic area.
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Educational Objectives:
Upon completion of this course, participants should be able to:
•Upon completion of this course, participants should be able to:
• Describe respiratory structure and function
• Define asthma and COPD as they relate to the clinical development of drugs
• Identify issues to consider in protocol and program development
• Summarize techniques used to measure drug effects on the respiratory system
• Explain current regulatory guidelines and endpoints affecting asthma and COPD drug development
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Key Topics:
• Respiratory Structure and Function Basics
• Spirometry and Lung Volume Testing
• Asthma and COPD Overview
• Basic Principles of Therapeutic Aerosols
• Toxicology Considerations in Drug Development
• Developing Inhaled Corticosteroids and Bronchodilators
• Drug Development Challenges for Asthma and COPD
• Patient Reported Outcomes
• Pharmacogenomics
• Pediatric Asthma: Challenges in Drug Development
• Endpoints of Asthma and COPD Drug Development (from FDA)
• Lessons Learned in Drug Development
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Course Director(s):
Marianne C Mann, MD
Clinical Drug Development & Regulatory Consultant
Gene L Colice, MD
Director, Department Pulmonary, Critical Care and Respiratory Service
Washington Hospital Center
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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