[IEEE-bhpjobs] July 12 mtg, regulatory perspective on biologics quality, deadline July 6

[esther L]

The North Carolina Pharmaceutical Discussion Group (NCPDG) of the 
American Association of Pharmaceutical Scientists (AAPS) will host a 
seminar on July 12, 2007. This seminar is also partially sponsored by 
RTI International.


     * Topic:  A Regulatory Perspective on Product Quality for 
Biologics: Development and Beyond

Susan Kirshner, Ph.D.
Division of Therapeutic Proteins
Office of Biotechnology Products
U.S. Food and Drug Administration
5600 Fishers Lane, Rockville MD 20857


     * Where:  Congressional Room

North Carolina Biotechnology Center
Research Triangle Park
15 T.W. Alexander Dr, Research Triangle Park, NC 27709
1-919-541-9366

     * When:   July 12 (Thursday), 11:30 am – 1:30 pm
     * Agenda:

Ø      11:30 am: On-site payment and lunch
Ø      11:45 am: RTI International presentation on services and facilities
Ø      12:00 noon: The thematic presentation

Must RSVP by July 6 (Friday), 2007 by emailing the completed 
registration form to ppande at rti.org  Space is limited, so please forward 
your payment while sending your email for registration to secure your seat.

Make Checks Payable to:  NCPDG
Mail to:                                                 or         Pay 
check/cash at the door.
Dr. Poonam Pande
303 Perry Creek Dr.
Chapel Hill NC 27514
Presentation Abstract
The Guidance for submission of Phase 1 investigational new drugs (INDs) 
emphasizes “the graded nature of manufacturing and controls information” 
and product quality information that should be submitted to the FDA for 
a Phase 1 IND.  This talk will provide insight into regulatory 
expectations with regards to submissions to the Agency for development 
and licensure of therapeutic proteins.  Evaluation of product 
immunogenicity, the integration of risk management and concepts of 
Quality by Design will be discussed.

Speaker’s Biography
Dr. Susan Kirshner received an MSc from University of North Carolina 
School of Public Health in the field of environmental toxicology.  She 
received a Ph.D. in Immunology from the Weizmann Institute of Science, 
where she worked on the development of a biological therapeutic.  Dr. 
Kirshner’s post-doctoral training was at the National Cancer Institute, 
where she did research on the regulation of transcription.  Dr. Kirshner 
worked both in the government and industry before joining the Division 
of Therapeutic Proteins at the FDA 4 ½ years ago.



J.J. Luo, PhD
Secretary of NCPDG

KBI BioPharma, Inc.
1101 Hamlin RD
Durham, NC 27704
Tel: (919) 479-9898 ext. 2032
Fax: (919) 620-7786
Email: jjluo at kbibiopharma.com
www.kbibiopharma.com


-- 
-- Esther L.,  esther-L at mailsnare.net or esther-L at alumni.virginia.edu
Speaking only for myself.
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