[MPWG] American Society of Pharmacognosy Workshop: Botanicals as New Drugs

[Trachtenberg, Alan (IHS/HQE)]

FYI

 

Alan Trachtenberg, MD, MPH, 
Indian Health Service, 
United States Public Health Service 
Phone: 301-443-0578 

The American Society of Pharmacognosy

Is proud to present:

 

A Workshop:  Botanicals as “New” Drugs 

 

Co-Sponsored by

Center for Drug Evaluation and Research, Food and Drug Administration

 

Saturday, August 5, 2006

11 AM – 4PM

 

Crystal Gateway Marriott - Arlington, Virginia (just across the Potomac River from Washington, D.C.)

 

 

In conjunction with 

 

The 47th Annual Meeting of the American Society of Pharmacognosy

Aug 6 - 9, 2006

 

COURSE DESCRIPTION:  

 

This Workshop is an introduction to the drug development process for naturally complex or heterogeneous products, such as botanicals.  Experts in the field will address the current status of USA drug development for botanical drugs.  Learn how to select a product for development as a “drug.”  Learn what FDA is looking for in the Chemistry, Manufacturing, and Controls (CMC) and Pharmacology-Toxicology sections of an Investigational New Drug (IND) application for a Botanical Drug.  

 

 

·         How does FDA define “botanical?” 

 

·         When should a botanical be developed as a “drug”?  

 

·         What are the differences between botanical “foods” and botanical “drugs”? 

 

·         What kinds of marketing claims can be made for botanical drugs? 

 

·         When should an Investigational New Drug (IND) application be filed with FDA?

 

·         How does the FDA process and review Botanical INDs and New Drug Applications (NDAs)?

 

·         What are the pertinent FDA regulations, policies and individuals you should know about for botanical drug development? 

 

 

WHO SHOULD ATTEND:    Ingredient Manufacturers, Suppliers, Directors of Research and Development, Researchers, Academicians, Potential Drug Sponsors, Medicinal & Natural Products Chemists, Pharmacologists, Toxicologists, Botanists, GMP Specialists, Clinical Investigators, Clinical Trials Specialists, Policy-makers.    

 

WORKSHOP REGISTRATION:

 

$295 – Workshop Only [Sat. Aug. 5]          $25 -   ASP Attendees

 

TO REGISTER—OR For more information please see:

 

 The American Society for Pharmacognosy

 

 www.phcog.org/AnnualMtg/Washington.html

 

 

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