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UPCOMING EVENTS

Save the date for our October members meeting:

Thursday, October 19th

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The Annual NCRAF Round Table Dinner

Save the Date: Thursday, November 9th!

 

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RAC(US) Workshop Seminar Series
Tuesdays starting June 6, 2017 and continuing until September 26, 2017, 6:00 - 8:00 pm

Location: DCRI, The Lower Level Conference Room (NOTE: This is NOT the Downtown Office)

See Here for Details

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RAC EU online Workshop

Register for the self-paced course starting Feb. 7, 2017 

Click to see details

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ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

Click to see details 

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                                                      NCRAF is on LinkedIn!

North Carolina Regulatory Affairs Forum

NCRAF is an association of regulatory affairs professionals centered in the Raleigh-Durham-Chapel Hill "Triangle" of North Carolina USA. NCRAF is dedicated to providing education and support for the continuing professional development of individuals who have an interest in regulatory affairs activities as they apply to research, development, or manufacture of drugs, biologics, or medical devices.


Upcoming NCRAF Events:

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NCRAF Members Meeting

 

September 21, 2017

Starting Your Regulatory Affairs Career

Speakers: Charity Schuller, Sheila Plant, and Marian Rhodes

Looking to start a career in regulatory affairs? Learn from three senior members of the establishment -
Find out how they got to where they are and what they're looking for in a RA rookie.

 

REGISTER HERE

 

Dr. Sheila Plant has 16 years of experience in biomedical sciences, including more than 9 years in clinical research. She earned her Ph.D. in neurobiology from the University of North Carolina at Chapel Hill, and her master of health sciences through the Duke University School of Medicine’s Clinical Research Training Program. Dr. Plant’s therapeutic areas of experience include oncology, dermatology, neurology, cerebrovascular, and cardiovascular. Since joining Cato Research, Dr. Plant has authored Food and Drug Administration (FDA) meeting packages, attended multiple face-to-face meetings with the FDA, developed regulatory strategies, and managed Investigational New Drug (IND) and New Drug Application (NDA) submissions.  As Assistant Director of Regulatory Strategy in the US, she provides strategic leadership for and manages the activities of the Regulatory Strategy department. In addition, Dr. Plant has many project-level responsibilities, including writing and reviewing regulatory, clinical, and scientific documents; clinical trial management, pharmaceutical development, and regulatory project management; providing scientific consulting; and assisting with the preparation of business development proposals. Dr. Plant has maintained her Regulatory Affairs Certification and is a member of Regulatory Affairs Professionals Society since 2011. While currently President of NCRAF, Dr. Plant has volunteered over the last 6 years in multiple roles with NCRAF including Chair of Communications (Membership), Treasurer, and President-elect.

 

Dr. Marian Saxon Rhodes has 19 years of experience in US regulatory affairs and medical writing. She earned her PhD in Pharmacology and Masters in Natural Sciences from the State University of New York, Buffalo, NY (Roswell Park Cancer Institute Graduate Division) and completed a Post-doctoral fellowship at UNC Lineberger Cancer Center. In her current role at QuintilesIMS, Dr. Rhodes uses her expertise in strategy and development or management of INDs, NDAs, and BLAs submitted in CTD format. Development of briefing documents and preparation and attendance at FDA meetings, interaction with FDA, acting as regulatory liaison for sponsor companies with the Agency.  Marian develops/writes/critically reviews clinical summaries for submissions including BLAs and NDAs.  She provides strategic consulting to customers from early development to filing.  She also acts as a US agent on behalf of customers, and provides overall project/program management of deliverables, resourcing and timelines. Dr. Rhodes also maintains her Regulatory Affairs Certification and is a member of Regulatory Affairs Professional Society.

 

Charity M. Schuller, RAC, Senior Director, Regulatory Affairs, has over 17 years of experience in pharmaceutical regulatory affairs. Dr. Schuller earned her PharmD from West Virginia University, and a Masters of Clinical Research from Campbell University.  Her current role at PPD includes regulatory project management, regulatory consultation, preparation and review of regulatory agency documents, development plans, support of REMS products and risk management programs, pediatric product development, assistance with FDA meeting preparation and attendance, late stage research and post-approval maintenance across a range of therapeutic areas. Dr. Schuller also provides global oversight of the Regulatory Informatics team covering intelligence, RIM and electronic publishing and submissions

 

 

 

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NCRAF RAC US WORKSHOP

In time for the 2017 (fall) RAC US Exam

Tuesdays starting June 6, 2017 and continuing until September 26, 2017, 6:00 - 8:00 pm
2400 Pratt St. Durham, NC (DCRI near Duke main hospital - NOT the downtown office)
Sessions are recorded for registered participants
Course tuition is $75.00
 

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ECTD Group Meetings

The ECTD Group has moved to quarterly meetings using a discussion group format rather than lectures on a specific topic.
The meeting schedule is listed below.  The specific topics announced in an email sent out by the ECTD Group and will be posted prior to each meeting on the NCRAF website.

All meetings are scheduled for 12:00 - 1:30 pm.  Location is variable. Please check the schedule below for location updates.

The current meeting schedule is:

March 23 (Thursday): Opportunity to share take-aways from DIA RSIDM 2017 - Impact Pharma, 79 TW Alexander Drive, Building 4401, Suite 100, RTP, NC

June 27 (Tuesday): Review of new/updated eCTD guidance documents - location to be determined

September 19 (Tuesday): Program and location to be determined

December 5 (Tuesday): Program and location to be determined

Click here to see details 

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