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Cancer: Pathophysiology, Current Therapies & Clincial Trials & Drug Development
Course # T06
April 26 - April 28, 2010
Start - 8:00
Finish - 5:00
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Hotel Information:
Georgetown University Conference Center
3800 Reservoir Road NW
Washington, DC 20057
(202) 687-3200
Rate: $
222
Deadline for Group Rate:
2010-04-05
Hotel Policy
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Registration Rate:
$1,695.00 Register by 03/11/10
$1,895.00 Register after 03/11/10
Cancellation Date: 4/16/10 (Cancellation fee is determined by date cancelled.)
Course Completed
Registration Policy
Continuing Education Credit:
ACPE:
0708-0000-10-005-L01-P (2.1 CEU)
Initial Release Date:
4/23/10
CBRN:
CE-P11908 21 Contact Hours
CME:
21 Hours of Category 1 Credit
VNA:
07-04-01 21 Contact Hours
Continuing Education Policy
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Course Description:
Day 1: 8:00 AM - 5:30 PM
Day 2: 8:00 AM - 5:00 PM
Day 3: 8:00 AM - 5:00 PM
This course will provide an overview of human cancer with discussions of specific cancer types, clinical and epidemiologic features, current therapeutics, and design and conduct of Phase I, II & III clinical trials. The US Food & Drug Administration (FDA) regulatory requirements for clinical trial designs and drug development programs are also covered.
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Who Should Attend:
Clinical research associates, regulatory affairs professionals, product managers, statisticians, clinical data managers, marketing research staff, and anyone working in oncologic drug development or moving to this area will gain knowledge from attending this course.
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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:
•Discuss the scope, nature and epidemiology of many human cancers with an emphasis on principles of case management of common malignancies.
•Describe specific applications of commonly used cancer treatments.
•Evaluate the design and conduct of oncology Phase I, II, and III clinical trials.
•Apply FDA requirements for oncology clinical trials and drug development programs to facilitate/expedite drug development.
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Key Topics:
•Overview of Oncology Drug Development
•Cancer Types: Melanoma, Lymphomas, Leukemias, Brain & CNS, Head & Neck, Lung, Esophageal, Stomach, Pancreatic, Hepatic, Colorectal, Renal & Bladder, Breast, Gynecologic, Prostate
•Clinical Trial Designs
•Pediatric Oncology
•Endpoints, Effectiveness and Approval
•Use of Biomarkers for Companion Drug-Diagnostic Co-Development
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Course Director(s):
Shamim Ruff
Exec Director, Global Regulatory Affairs, Global Regulatory Affairs & Safety
Amgen, Inc.
Helen B Eliopoulos, MD
Oncology Development Consultant
PBD Consultants LTD
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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