[IEEE-bhpjobs] [Fwd: The NC Pharmaceutical Discussion Group Presents: "How Safe is Safe?... ]

[Esther L]

-------- Original Message --------
Subject: 	The NC Pharmaceutical Discussion Group Presents: "How Safe is
Safe?...
Date: 	Mon, 30 Aug 2004 11:10:36 EDT
From: 	AIATriangle at aol.com
To: 	ProfLink at aol.com



*/The NC Pharmaceutical Discussion Group Presents:/*


*Dr. David Elder, Ph.D.   *
GlaxoSmithKline, New Chemical Entities, Pharmaceutical Development,
Ware, UK


*"How Safe is Safe?  Managing Genotoxic Impurities in Drug Substances
and Drug Products within GSK"
*

*
*

*Wednesday, September 15, 2004
*Sheraton Imperial Hotel and Convention Center
Research Triangle Park
4700 Emperor Blvd, Durham NC 27703
1-919-941-5050



6:00 PM Cash Bar (one beverage included with dinner)
6:30 PM  Dinner
Seminar following Dinner
Cost: $55 if paid by Sept. 10
Otherwise, $60
$25 for university students and  faculty

PLEASE RESPOND TO sara_wu at eisai.com <mailto:sara_wu at eisai.com> to
register for this event (the registration form is attached).

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*Abstract***
Genotoxic impurities are currently receiving a lot of world-wide
regulatory focus.  The presentation will provide an overview of what
constitutes a genotoxic impurity and alignment with ICH Q3A/B/C.  Then
the  management of genotoxic impurities within pre-clinical functions
(chemistry, pharmacy and safety assessment) at GSK will be described.
   The current regulatory views (both known and perceived) of FDA and EMEA
will be discussed.  Finally, the risk/benefit of ingestion of genotoxic
impurities will be discussed from a pragmatic perspective.

*Resume of Background***
Dave Elder is a native of England who has a Bachelor's degree in
Chemistry, Masters degree in Analytical Chemistry and a PhD in Chemistry
from the University of Edinburgh.  He has spent 27 years working within
the pharmaceutical industry for Sanofi, Syntex, SmithKlineBeecham and
subsequently GSK.  For the last 11 years he has been involved in product
development and currently heads up the New Chemical Entities group at
Ware in England.  His group develop oral, injectable and intra-nasal
dosage forms.  His interest in genotoxic impurities first arose from
evaluating the safety risk from a generic competitor product and he has
been involved in rolling out the management of genotoxic impurities
within GSK.



-- 
--  Esther L., esther_L @ ieee.org, 'esther_ letter L @ ieee.org'.
Speaking only for myself


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