[IEEE-bhpjobs] topic: eCTD - SoCRA North Carolina East (RTP) Chapter Meeting - June 5
Esther Lumsdon
esther_l at earthlink.net
Wed May 24 09:22:16 EDT 2006
-----Forwarded Message-----
>From: jmarnold at cato.com
>Sent: May 24, 2006 8:58 AM
>To: esther_L at ieee.org
>Subject: SoCRA North Carolina East (RTP) Chapter Meeting - June 5
>
>
>
>
>Hi Esther,
>
>Please see the attached meeting announcement.
>
>Non-SoCRA members are welcome to attend open meetings.
>
>Please feel free to share SoCRA meeting information with your colleagues.
>
>( If you able to attend the June 5th meeting, please take a moment to say
>"hello" )
>
>
>
>----- Forwarded by Joyce Arnold-Avant/CRD/Cato on 05/24/2006 07:51 AM -----
>
>
>
> SOCRAMAIL at aol.com
>
> 05/23/2006 04:38 To
> PM
> cc
>
> Subject
> SoCRA North Carolina East (RTP)
> Chapter Meeting - June 5
>
>
>
>
>
>
>
>
>
>
>
>Greetings,
>
>The June, 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, 5 June 06, at Cato Research, Ltd. from
>6:00 to 7:00 PM.
>
>This month's meeting will feature Jeremy Cromer, B.S., Coordinator of
>Regulatory Operations, Cato Research, Ltd. (CATO), Durham, North Carolina.
>He will be speaking about submitting drug applications electronically
>(eCTDs). A brief summary of the presentation and a biosketch for Mr. Cromer
>can be found below.
>
>
>OUR TOPIC: eCTDs Made Easy: All You Really Need to Know
>
>SPEAKER: Jeremy Cromer, B.S.
>
>SUMMARY:
>
>Mr. Cromer?s presentation will focus on the relatively recent
>implementation of electronic submissions in eCTD format by the FDA. Program
>features include:
> eCTD Demonstration
> The eCTD Explained: How? Why? When?
> The XML Backbone and Metadata
> Lifecycle Management in the eCTD Environment
> The Benefits of e-Submissions vs. Paper Submissions
> Practical Considerations and Strategies Surrounding the
> Production of eCTD Submissions
>
>
>ABOUT OUR SPEAKER:
>
>Mr. Cromer has 5 years? experience in the pharmaceutical industry,
>including more than 2 years specializing in submissions to regulatory
>authorities and regulatory consulting. Mr. Cromer serves on individual
>project teams, assisting authors of regulatory documents, aiding in the
>development of regulatory strategy, and managing project timelines. He is
>responsible for facilitating and coordinating the activities of the
>Regulatory Submissions Group at Cato Research and is responsible for the
>creation and maintenance of company infrastructure related to regulatory
>submissions.
>
>
>Mr. Cromer has experience in the development of all types of regulatory
>submissions, including electronic Common Technical Documents (eCTDs), New
>Drug Applications (NDAs), Investigational New Drug applications (INDs),
>Biologics License Applications (BLAs), Special Protocol Assessments, Orphan
>Drug Designation Requests, pre-IND meeting requests and packages, eNDAs,
>eINDs, and Drug Master Files (DMFs). Before coming to Cato Research, Mr.
>Cromer served as a research associate at Duke University Medical Center
>where he worked in the field of proteomics, specializing in lung cancer
>diagnostics. He has a bachelor?s degree in chemistry from Duke University,
>and his specific areas of expertise include proteomics, oncology, and mass
>spectrometry.
>
>
>If you have any questions, do not respond to this email, 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 Fairfield 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 Fairfield Inn will be on|
>| the right) |
>| � |
>| Drive around to the back of the office building to locate parking |
>| |
>| |
>| Joyce Arnold-Avant, CCRP (SoCRA) |
>| 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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