Hotel Information:
Hyatt Arlington
Hyatt Arlington
1325 Wilson Boulevard
Arlington, VA 22209
(703) 525-1234
Rate: $
Deadline for Group Rate:
Hotel Policy
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Registration Rate:
$1,495.00 Register by 09/20/10
$1,695.00 Register after 09/20/10
Cancellation Date: 10/25/10 (Cancellation fee is determined by date cancelled.)
Register Now
Registration Policy
Continuing Education Credit:
ACPE:
0708-0000-10-040-L03-P (1.4 CEU)
Initial Release Date:
11/3/10
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 - 5:00 PM
This course, taught by industry and FDA faculty, provides strategies for meeting biopharmaceutic and clinical pharmacology/pharmacokinetic requirements from the IND to the NDA.
Emphasis will be on the studies needed to sucessfully file an IND and NDA from the Clinical Pharmacology perspective. Various topics such as bioanalysis, biopharmaceutics, bioequivalence, drug disposition, PK in special populations, pharmacogenomics and pharmacometrics will be covered.
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Who Should Attend:
This course is intended for those who work primarily in PK, and for those primarily responsible for regulatory filings (regulatory affairs, clinical). FDA Reviewers and other personnel will also benefit from this course.
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Educational Objectives:
Upon completion of this course, participants should be able to:
•Define method validation techniques for bioanalysis
•Apply concepts of BCS to interpretation of biopharmaceutic studies
•Understand characterization of drug disposition and drug-interaction potential
•Discuss the importance of phamracogenomics and pharmacometrics
•Identify key features of Thorough QT Study (TQTS)
•Apply strategies learned in the program to sucessfully submit the Clinical Pharmacology section of an NDA
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Key Topics:
•Pharmacokinetic Concepts
•Bioanalysis
•Biopharmaceutics
•Bioequivalence
•Characterizing metabolism and excretion
•Drug-drug interaction studies
•PK in special populations
•Pharmacogenomics
•Pharmacometrics
•Biologics
•QTc
•Content and format of the Clinical Pharmacology (CP) section of an NDA
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Course Director(s):
Punit H Marathe, PhD
Director, Metabolism and Pharmacokinetics
Bristol-Myers Squibb
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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