[MPWG] 2006 EVENTS: ASP-FDA Botanical Drug Workshop; DIA-ISAPP Probiotics Conf

Fri May 19 18:00:16 CDT 2006

RE:    EVENTS - Natural Health Products & Ingredients 2006  [WASHINGTON DC
METRO AREA]

On behalf of the respective Program Planning Committees, enclosed please
find information on TWO EVENTS that may be of interest to your Members,
Colleagues and/or Readership:

*	ASP-FDA Workshop on Botanicals as "New" Drugs  - Sat, Aug 5, 2006
[Crystal-Gateway Marriott, Arlington, VA] 

*	DIA-ISAPP First International Conference on Probiotics as Foods and
Drugs - Scientific and Regulatory Challenges - October 16-17, 2006 

[University of Maryland Conference Center, College Park Campus] 

See information below, and Attached Flyers.  

We hope you will POST and DISSEMINATE this information.  

Should you have questions, please do not hesitate to contact the Sponsoring
organizations (see flyers, or below).  Or you may contact me directly at the
numbers below.   

Thanking you in advance, 

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 
 <mailto:fhoffman at heterogeneity-LLC.com> fhoffman at heterogeneity-LLC.com

 <http://www.heterogeneity-LLC.com> www.heterogeneity-LLC.com

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

FDA logo

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

  <http://www.phcog.org/AnnualMtg/Washington.html>
www.phcog.org/AnnualMtg/Washington.html

Contact:  Dr. Tawnya McKee, ASP Conference Organizer

(e-mail:   <mailto:mckee at ncifcrf.gov> mckee at ncifcrf.gov )

Dr. Freddie Ann Hoffman, Workshop Organizer

(e-mail:   <mailto:Fhoffman at heterogeneity-LLC.com>
Fhoffman at heterogeneity-LLC.com)

202-545-6843

______________________________________________________

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 <http://www.diahome.org/> 

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