NCRAF is on LinkedIn!            NCRAF LMS is Here!

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.

 The next meetings of the 2023 Year!

March 23, 2023

An Overview of FDA Orphan Drug Designation

The FDA has made it a key priority to support the development and evaluation of new treatments for rare diseases. The FDA has the authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. This presentation will discuss the overall Orphan Drug Designation program and process and include Orphan Drugs, Rare Diseases, the Orphan Drug Act (ODA), Orphan Drug Designation Program, Benefits of ODD, ODD Requests and a Review of Criteria.


Rachel Capone, MSHS

Rachel is a Regulatory Affairs Manager at Syner-G BioPharma Group. Rachel has over 7 years of Regulatory Affairs experience in the pharmaceutical industry. Rachel received a Master of Science in Health Science (MSHS) in Regulatory Affairs from The George Washington University School of Medicine and Health Sciences in 2019. Rachel has spent most of her career on the Sponsor side of drug development with a focus on global regulatory strategy, R&D, early phase development and post approval projects. Rachel has been involved in receiving FDA approval for 2 major NDA submissions and multiple INDs.


Networking: 5:30 - 6:30 pm EDT.
Seminar: 6:30 - 7:30 pm EDT

IQVIA at Innovation Park,
2400 Ellis Road, Durham, NC, 27703


Tuesday, APRIL 25, 2023

Algorithm-Based Clinical Decision Support (ABCDS) Oversight:
A framework for the oversight of algorithms to be deployed at Duke Health that fosters regulatory compliance

Algorithm-Based Clinical Decision Support (ABCDS) Oversight is a framework for the governance, evaluation and monitoring of algorithms used at Duke Health. This framework introduces checkpoints throughout the development lifecycle of algorithmic tools as well as after deployment to ensure regulatory compliance, safety, fairness, and high-quality care..


Amanda Parrish, PhD, RAC,
Executive Director of Regulatory Affairs and Quality, Duke University,
Nicoleta Economou, PhD, Director of the Algorithm-Based Clinical Decision Support (ABCDS) Oversight, Duke University

Amanda Parrish, PhD, RAC is the Executive Director of Regulatory Affairs and Quality in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Parrish oversees a team of Regulatory and Quality professionals who provide guidance on FDA regulations for product development, clinical trials research, and manufacturing at Duke.  Dr. Parrish is responsible for managing the groups that provide support and guidance to Duke investigators regarding the regulatory and quality requirements relevant to their clinical research activities. She oversees and performs a variety of services including regulatory/quality education, regulatory/quality consultation, and implementation of new educational, operational, and collaborative initiatives throughout Duke. She has conducted numerous meetings with the FDA, and her regulatory/GMP experience includes a variety of therapeutic areas, including drug, biologics, and devices, and ranges from early Phase 1 activities through product licensing. She was the primary regulatory project leader for the US approval of the Carolinas Cord Blood Bank BLA and continues to oversee the regulatory and quality assurance activities associated with the Duke BLA. Dr. Parrish obtained a PhD in Molecular Cancer Biology from Duke University and then transitioned into her first regulatory role as a Regulatory Affairs Scientist at Duke University.

Nicoleta Economou, PhD, serves as the director of the Algorithm-Based Clinical Decision Support (ABCDS) Oversight leading the operations and framework design effort for the governance, evaluation, and monitoring of ABCDS software at Duke. She is also leading all Duke AI Health initiatives relevant to evaluation and governance of health AI technologies, and leads operations of the Coalition for Health AI, a coalition establishing the guidelines and guardrails for health AI technologies. Previously, Dr. Economou led projects supporting a learning health system at Duke working alongside faculty and health system leadership to bring together people, processes, technologies, and data streams required to drive evidence-based continuous improvement and innovation in health care delivery and operations. Before joining Duke, she worked in the life-science and pharmaceutical industry, where she managed clinical analytics portfolios to drive data-informed decisions for drug development with key focus on clinical data review, clinical safety review, and clinical operations. Additionally, she developed, validated and deployed risk models and helped design and define metrics for monitoring clinical trials using analytics software. Dr. Economou did her postdoctoral training at the UNC Eshelman School of Pharmacy and received her PhD from Drexel University College of Medicine.


Networking: 5:30 - 6:30 pm EDT.
Seminar: 6:30 - 7:30 pm EDT

IQVIA at Innovation Park,
2400 Ellis Road, Durham, NC, 27703



Registration for the 2022 RAC Workshops is still OPEN!!

You must be a member to register. Workshop registration is $75

Live sessions were held from June-September and are now complete.

Recordings of all sessions are still available.  

REGISTER for Device Workshop
REGISTER for Pharm-Bio Workshop



Membership dues for 2023 will continue to be $20 for the year.

When your membership renewal comes up during the 2023 calendar year, you will receive, via email,
an invoice for $20.
Please pay via the invoice (there's a link in the email),
the old "log in to the website and renew" is no longer available.