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Hyatt Regency Bethesda , Bethesda, MD USA
Apr 16 2012 8:00AM - Apr 17 2012 4:45PM
of clinical pharmacology and pharmacokinetic concepts and regulatory requirements. The agenda for this course is structured based on the building blocks for the Clinical Pharmacology reviewing discipline and associated FDA guidelines. This course brings together faculty from both industry and FDA to share strategies for compliance with biopharmaceutic and pharmacokinetic requirements to successully file an IND and NDA. This course will allow ample time for questions and interaction with industry and FDA representatives. What You Will Learn: • Bioanalytical requirements • Biopharmaceutics considerations • Bioequivalence guidance • Metabolic and transporter phenotyping • Clinical drug-drug interaction assessments • Pharmacogenomics principles • Pharmacokinetics in special populations • Pharmacometrics applications • Unique PK-PD aspects of biologics • QTc timing and impact Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA. Event Code:
12401
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Organized by:
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DIA |
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Invited Speakers:
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Representative Invited
Deputy Director, Division of Clinical Pharmacology
FDA, United States
Gary Bowers, PhD
US Biotransformation & Drug Disposition
GlaxoSmithKline, United States
John Crison
Research Fellow
Bristol-Myers Squibb, United States
Representative Invited
Clinical Pharmacology Reviewer, Division of Clinical Pharmacology
FDA, United States
Representative Invited
Senior Advisor OLP
FDA, United States
Representative Invited
Pharmacometrics Reviewer, CDER
FDA, United States
Punit Hemant Marathe, PhD
Group Director, Department of Metabolism and Pharmacokinetics
Bristol-Myers Squibb Canada, United States
Representative Invited
Director
FDA, United States
Representative Invited
Team Leader
FDA, United States
Representative Invited
Clinical Pharmacologist, Office of Clinical Pharmacology, OTS, CDER
FDA, United States
Representative Invited
Deputy Directory
FDA, United States
Simon Yuji Zhou, PhD
Sr. Director, Clinical Pharmacology
Celgene Corporation, United States
Representative Invited
QT-IRT Scientific Lead, Office of Clinical Pharmacology, CDER
FDA, United States
Li Zhu
Sr. Research Investigator
Bristol-Myers Squibb, United States
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Deadline for Abstracts:
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Call contact
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Registration:
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For registration questions, please contact Vicki Adkinson at +1-215-442-6162 or Vicki.Adkinson@diahome.org
For agenda details, please contact Colleen Buckley at +1-215-442-6108 or Colleen.Buckley@diahome.org
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E-mail:
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colleen.buckley@diahome.org
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