[IEEE-bhpjobs] Fw: SoCRA RTP / NC East Chapter Meeting - August 7, 2006 (6:00 - 7:00 PM)
Esther Lumsdon
esther_l at earthlink.net
Sat Aug 5 22:32:03 EDT 2006
-----Forwarded Message-----
>From: jmarnold at cato.com
>Sent: Aug 3, 2006 9:17 AM
>To: jmarnold at cato.com
>Subject: SoCRA RTP / NC East Chapter Meeting - August 7, 2006 (6:00 - 7:00 PM)
>
>
>
>----- Forwarded by Joyce Arnold-Avant/CRD/Cato on 08/03/2006 07:31 AM -----
>
>
>
> Subject
> SoCRA RTP/NC East Chapter Meeting -
> August 7, 2006
>
>Greetings,
>
>The August, 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, August 7, 2006, at Cato Research, Ltd.
>(CATO), Durham, from 6:00 to 7:00 PM.
>
>This month's meeting will feature Vicki Tibbs, Ph.D., R.A.C., Associate
>Director and Senior Scientist, Regulatory Affairs, Cato Research. Dr. Tibbs
>will be speaking on the subject of Exploratory INDs. A brief summary of the
>program and a biosketch for Dr. Tibbs can be found below.
>
>OUR TOPIC: The Exploratory IND and the Critical Path to New Medical
>Products
>
>SPEAKER: Vicki Tibbs, Ph.D., R.A.C.
>
>
>SUMMARY: Dr. Tibbs' presentation will focus on understanding potential uses
>of the Exploratory IND as part of FDA's Critical Path Initiative. The
>Critical Path Initiative is FDA's effort to stimulate and facilitate a
>national effort to modernize the scientific process through which a
>potential human drug, biological product, or medical device is brought from
>"proof of concept" into a medial product. FDA has recently identified early
>phase clinical actives under the guise of Exploratory INDs as one
>development tool that may help facilitate more expeditious development of
>drugs along the critical path.
>
>Upon completion of this presentation the participants will:
>
>� Have an understanding of the FDA's Critical Path Initiative
>� Have an understanding of the differences between an IND and Exploratory
>IND
>� Have an understanding of how Exploratory INDs are intended to supplement
>the Critical Path Initiative
>� Have an understanding of the impact of Exploratory INDs on a drugs the
>clinical, CMC, and nonclinical development plan
>
>
>ABOUT OUR SPEAKER:
>
>Dr. Tibbs has more than 5 years? experience in drug development and more
>than 6 years? experience in scientific research. She is responsible for
>facilitating the activities of the Regulatory Strategy group at Cato
>Research and is responsible for the creation and maintenance of company
>infrastructure related to regulatory deliverables. As a regulatory senior
>scientist at Cato Research, Dr. Tibbs serves as project manager or program
>director and manages all aspects of her projects including clinical trial
>conduct, determining regulatory strategy, overseeing the authors of
>regulatory documents, and managing project budgets and timelines. She has
>extensive project management experience in the areas of international
>clinical trials, safety reporting, Investigational New Drug applications,
>marketing applications, development plans, and regulatory strategy. Dr.
>Tibbs received her doctorate in neuropharmacology and has led or made
>significant contributions to development programs in a number of
>therapeutic areas including oncology, obesity, sedation, psoriasis, and
>pain management. She is Regulatory Affairs Certified by the Regulatory
>Affairs Professional Society.
>
>
>If you have any questions, contact
>jmarnold at cato.com or at any of the numbers below.
>Phone (919) 768-1201 -- Fax (919) 361-2290 -- Cell 452-0905
>
>The meeting will be held at Cato Research Ltd.
>
>Cato Research is located at 4364 S. Alston Ave. (Westpark Corporate Center)
>All attendees should park and enter through the back of the building. The
>meeting will be from 6:00-7:00 in the 3rd floor Auditorium. Please sign in
>at the reception area and take the elevators to the 3rd floor. Exit the
>elevator to your left and follow the arrows to the Auditorium straight
>ahead. Upon entering the Auditorium, please sign the SoCRA attendance
>sheet.
>
>Directions to Cato Research
>
>
>|--------------------------------------------------------------------------|
>|From Raleigh/RDU Airport to Cato Research: |
>| |
>| |
>| |
>| |
>| |
>| � |
>| Take Interstate 40 WEST (toward Chapel Hill) to Exit 278 (Apex 55/54) |
>| � |
>| Drive straight through the stoplight, over the railroad tracks, into |
>| WESTPARK CORPORATE CENTER |
>| (The Waffle House will be on the left and the Comfort Inn will be on |
>| the right) |
>| � |
>| Drive around to the back of the office building to locate parking |
>| |
>| |
>| |
>|Directions from Greensboro/Chapel Hill to Cato Research: |
>| |
>| |
>| |
>| |
>| |
>| � |
>| Take Interstate 40 EAST toward Durham/Raleigh to EXIT 278 (Apex 55/54)|
>| � |
>| Drive under the bridge to your left and turn RIGHT at the next light |
>| � |
>| Drive over the railroad tracks, into WESTPARK CORPORATE CENTER |
>| (The Waffle House will be on the left and the Comfort Inn will be on |
>| the right) |
>| � |
>| Drive around to the back of the office building to locate parking |
>| |
>| |
>| Joyce Arnold-Avant, CCRP |
>| Executive Administration |
>| Cato Research / Durham |
>| |
>|--------------------------------------------------------------------------|
>
>
>
>
>
Esther L., esther_L at ieee.org
sending via webmail; please reply to esther_L at ieee.org\r\n
Note that e.Lumsdon at duke.edu and Lumsd004 at dcri.duke.edu are no longer functioning email addresses.\n
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