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Upcoming Events

Development of Biosimilars in the U.S.

Thursday, October 16, 2014

Kamali Chance, Quintiles, Inc.

Register Now!


NCRAF Roundtable Dinner

Thursday, November 13, 2014

UNC Friday Center

Mark your calendars! Event will feature a different speaker and topic at each table. Registration will open when speakers and topics are finalized.


View recordings or slide presentations of past events:

 Dr. Robert Califf - Disrupting Clinical Research 01 May 2014

 Ken Edds Talk - What FDA Teaches Its Investigators




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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.

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To renew your membership, please perform the following steps - in order:

1. click on the Membership Renewal button (at the left side of the webpage).
2. login when asked using your info (If you don't have it or forgot it, contact Membership).
3. you will need a credit card (Visa, MC, AMEX).
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5. Once logged in, the "Members Only" section will appear and you can navigate to the "Profile" page to change your password, etc.


Development of Biosimilars in the U.S.
Thursday, October 16, 2014

Register Today!

Short Description: Biological medicines are large, complex molecules produced by living organisms for the prevention, treatment, or cure of a disease. Biosimilars are versions of biological medicines that share an amino acid sequence in common with their originators (the original biological medicine) and have demonstrated a high degree of similarity in physiochemical characteristics, efficacy, safety, and quality; however, they are much more affordable.

Speaker Biography: Kamali Chance, MPH, PhD, RAC is the Sr. Director and Head of Global Biosimilars Regulatory Strategy in the Global Biosimilars Unit at Quintiles