[IEEE-bhpjobs] Fwd: SoCRA NC East Chapter Meeting - March 6, 2006

[esther-l@mailsnare.net]

-----Original Message-----
From: Kimberly Cotten [mailto:kimcotten at gmail.com]
Sent: Wednesday, February 22, 2006 12:38 PM
To: ''esther L''
Subject: FW: SoCRA NC East Chapter Meeting - March 6, 2006

Hope to see you Monday!

 

Kim Cotten

 <mailto:kimcotten at gmail.com> kimcotten at gmail.com (new address)

919-542-3241 (Home)

919-971-5828 (Cell)

If it is to be, it's up to you.

 

  _____  

From: SOCRAMAIL at aol.com [mailto:SOCRAMAIL at aol.com] 
Sent: Tuesday, February 21, 2006 1:48 PM
To: undisclosed-recipients:
Subject: SoCRA NC East Chapter Meeting - March 6, 2006

 

Greetings,

The March, 2006, meeting of the Clinical Research Professionals of North
Carolina (a chapter of SoCRA also referred to as NC East or the RTP chapter)
will be held on Monday, March 6, 2006, at Duke Clinical Research Institute
(DCRI) from 6:00 to 7:00 PM.

This month's meeting will feature Will Lee, Ph.D., R.A.C., Regulatory
Scientist / Regulatory Affairs, Cato Research Ltd. (CATO), Durham, North
Carolina. He will be speaking about regulatory oversight of gene therapy. A
brief summary of the program and a biosketch for Dr. Lee can be found below.


REPLY TO: jmarnold at cato.com  <mailto:Juliette_Nelsen at med.unc.edu> 

OUR TOPIC: Regulatory Considerations Associated with Gene Therapy Clinical
Trials in the United States

SPEAKER: Will Lee, Ph.D., R.A.C.

SUMMARY:

Dr. Lee's presentation will focus on the regulatory oversight of gene
therapy and is geared toward investigators, study coordinators, monitors and
study staff. Upon completion of this program the participants will: 

* Have an understanding of the areas of oversight of FDA and RAC in gene
therapy 
* Have an understanding of the authority of the IBC and RAC Committee 
* Have an understanding of the recent history of gene therapy clinical
trials


ABOUT OUR SPEAKER:

Dr. Lee has been working in scientific research and development (academia
and industry) for more than 14 years, specializing in Gene Therapy. During
his employment with CATO, Dr. Lee has been involved in the design of Phase I
and Phase II clinical studies for a gene therapy drug. He has also
participated in the preparation and submission of IND Information Amendments
(CMC, pharmacology, and toxicology), a clinical study report for intravenous
immunoglobulin product, and a pre-IDE meeting package. Dr. Lee has
experience in pharmacogenetics and the therapeutic areas of infectious
diseases and oncology. In addition, he has received regulatory affairs
certification by the Regulatory Affairs Certification (RAC) Board by the
Regulatory Affairs Professionals Society. 

If you have any questions, contact: jmarnold at cato.com
<mailto:Juliette_Nelsen at med.unc.edu> . 

The meeting will be held at the Duke Clinical Research Institute (DCRI) in
the North Pavilion on the Duke Campus. The North Pavilion is located at 2400
Pratt Street. All attendees should park in the adjacent parking garage. A
ticket must be taken to lift the gate, but no attendant will be on duty and
the gate will be up when you exit. The meeting will be from 6:00-7:00 in the
Lower Lecture Hall. As you enter the building, security is on your right.
Turn left to take the elevator to lower level or walk down the flight of
stairs directly in front of you. From the foot of the stairs, the lecture
hall is located on the right. 

Directions to Duke University North Pavilion From I-40 West take the Durham
Expressway/ NC 147 (Exit279B) Continue on the Durham Expressway. Exit on
Hillandale Rd. / Fulton St. (exit15b) Stay in the left lane. At the light at
the bottom of the ramp, turn left onto Fulton Street. Go past the parking
garage and North Pavilion Buildings Turn left onto Pratt St., Take the first
drive on the left, at the stop sign, turn left again towards the front of
the building Enter garage at the Patient and Visitor Only entrance. You will
need to take a ticket to enter. The numbers of the garage floors do not
match the floors in the building, so the main entrance of the building is
actually Floor 2 of the garage. As you enter the building, security is on
your right. Turn left to take the elevator to lower level or walk down the
flight of stairs directly in front of you. From the foot of the stairs, the
lecture hall is located on the right. 

>From Charlotte, Greensboro and areas West of Durham -Take 85 North, past
Greensboro, Burlington, 85 will merge with 70, and later with 15-501 by-pass
Get off exit at Hillandale Road, Exit 174 Turn right, go past the Hillandale
Golf course Continue straight, go under 147, Street name will change to
Fulton Go past the Duke University parking garage and North Pavilion
Buildings Turn left onto Pratt Street, which is the first left Continue on
Pratt (very short road). Take your first left. At the stop sign, turn left
again toward the front of the building Enter garage at the "Patient and
Visitor Only" entrance. You will need to take a ticket to enter. The numbers
of the garage floors do not match the floors in the building, so the main
entrance of the building is actually Floor 2 of the garage. As you enter the
building, security is on your right. Turn left to take the elevator to lower
level or walk down the flight of stairs directly in front of you. From the
foot of the stairs, the lecture hall is located on the right. 
=