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Interactive FDA Presentation on Exploratory Investigational New Drug (IND) Requirements

 
  August 28, 2006  
     
 
Drug Information Association, Online
Sep 15 2006


WEBINAR HIGHLIGHTS:
•Overview of the chemistry and pharmacology requirements associated with exploratory IND.
•Tips to help you efficiently develop promising drug and biologic candidates while maintaining the safety of human subjects.
•Presentation of the necessary preclinical and clinical approaches and CMC information to be considered when planning
Exploratory studies in humans, including studies of closely-related drugs or therapeutic biological products under an Investigational New Drug (IND) application (21 CFR 312).
 
 
Organized by: Drug Information Association
Invited Speakers: GEORGE Q. MILLS, MD
Director, Medical Imaging and Radiopharmaceutical
Drug Products, Office of New Drugs, CDER, FDA

ADEBAYO LANIYONU, PHD
Supervisory Pharmacologist, Office of Oncology Drug
Products, Office of New Drugs, CDER, FDA

RAVI S. HARAPANHALLI
Supervisory Interdisciplinary Scientist, CMC, Office of
New Drug Quality Assessment, CDER, FDA

DAVID JACOBSON-KRAM, PHD
Associate Director for Pharmacology and Toxicology,
Office of New Drugs, CDER, FDA

MONICA E. CAPHART
Senior Compliance Officer, Office of Compliance,
CDER, FDA

 
Deadline for Abstracts: -
 
Registration: http://www.diahome.org/product/12149/06243.pdf
E-mail: dia@diahome.org
 
   
 
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