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

[esther L]

Regulatory oversight of gene therapy


esther-l at mailsnare.net wrote:
> -----Original Message-----
> 

> 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   
> 
> 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. 
> =
> 
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> 
> 

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


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