[MPWG] Fw: 2006 Natural Health Product Events

[Patricia_DeAngelis at fws.gov]

SUBJECT:    2006 Natural Health Product & Ingredients EVENTS [WASHINGTON 
DC METRO AREA]
 
On behalf of the respective Program Planning Committees, the following 
Events may be of interest to you and/or your Colleagues: 
 
August 5, 2006:   SPONSOR OPPORTUNITY 
American Society of Pharmacognosy – FDA Workshop on Botanicals as “New” 
Drugs 
Crystal-Gateway Marriott (Arlington, Virginia) - 
 
October 16-17, 2006:    EXHIBITOR OPPORTUNITY 
First International DIA-ISAPP Conference on Probiotics as Foods and Drugs 
– Scientific and Regulatory Challenges 
University of Maryland Conference Center (College Park Campus – Adelphi, 
Maryland) 
 
See information below. 
 
We hope you will POST and DISSEMINATE this information.  TO REGISTER, 
please Contact the Sponsoring Organizations. 
For questions, feel free to contact me at the numbers below. 
 
Regards, 
 
Dr. Freddie Ann Hoffman
--- Conference Chair 
 
Freddie Ann Hoffman, MD 
HeteroGeneity, LLC 
5611  16th Street, NW 
Washington, DC  20011-6809 
Tel.:  202-545-6843 
Mobile:  202-294-5819 
Fax:  202-545-6844 
fhoffman at heterogeneity-LLC.com
www.heterogeneity-LLC.com
 
**   SPONSOR OPPORTUNITY ** 
 
The American Society of Pharmacognosy 
Is proud to present:
A Workshop:  Botanicals as “New” Drugs 
Co-Sponsored by the
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
 
Contact:  Dr. Tawnya McKee, ASP Chair, Conference Program Committee
e-mail:  mckee at ncifcrf.gov
Dr. Freddie Ann Hoffman, Workshop Organizer
e-mail:  Fhoffman at heterogeneity-LLC.com
Tel:  202-545-6843
______________________________________________________
 
 
**   EXHIBITOR OPPORTUNITY ** 
 
Natural Health Products Special Interest Area Community
Drug Information Association (DIA) 
 
in conjunction with the
International Scientific Association for Probiotics & Prebiotics 
present: 
 
The First DIA International Conference on 
PROBIOTICS AS FOODS & AS DRUGS -
SCIENTIFIC & REGULATORY CHALLENGES
16 -17 October 2006
University of Maryland Conference Center 
College Park, Maryland
Chairs: 
Patricia Hibberd, MD, PhD - Tufts New England Medical Center
James Heimbach, PhD - JHeimbach, LLC
Freddie Ann Hoffman, MD - HeteroGeneity, LLC
[Continuing Education Credits]
Contact:   Drug Information Association (215-442-6100)
www.diahome.org
 
 
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