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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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Members Meeting

February 18, 2021

6:30 - 8:00 pm via Zoom

Global Regulatory Strategies

Birgitta Hedin

Head, Global Regulatory Affairs - Rare Diseases

Chiesi Group

The presentation will focus on Regulatory's role in product development and development of global regulatory strategy to aid company objectives. A comprehensive strategy includes regulatory intelligence, consultation strategy (with regulators), risk assessment, Target Product Profile (TPP), label and much more. Birgitta believes the aim of a global regulatory strategy is to “find a way through the regulatory jungle,satisfying different customer needs in the shortest timeframe possible”

Birgitta Hedin has extensive experience in global regulatory affairs, having worked at Astra Zeneca, Boehringer Ingelheim, CSL Behring and several other companies before making Chiesi her current home. She has also served in the capacity of Asian Regulatory Strategy Director based in Japan. Birgitta’s expertise is in ensuring regulatory strategies are developed clearly in line with product development objectives.Currently, Birgitta is developing and expanding the Rare Diseases effort at Chiesi Group

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Members Meeting

March 18, 2021

6:30 - 8:00 pm via Zoom

Limiting the Clinical Trial to What You Need
(Eliminating the kitchen sink)

David Jensen, PhD, RAC

Regulatory Affairs Scientist

Duke Office of Regulatory Affairs and Quality

This talk will present a case study of a streamlined medical device clinical trial involving 2 companies, a university network of Duke/UC San Fransisco/George Washington Univ., and a public health laboratory. We’ll discuss the streamlined design, the regulatory implications of the design, and the project’s final output leading to 510(k) clearance of expanded labeling.

David Jensen, Ph.D., RAC is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. David uses his 15+ years of experience in US FDA-regulated medical product development to advise Duke Faculty and project teams, primarily at the Duke Clinical Research Institute (DCRI), on regulatory strategy development, FDA meetings, regulatory submissions, product manufacturing, and preclinical testing. He assists project teams with the development, coordination, and implementation of complex regulatory projects involving drugs, biologics, devices (including Software as a Medical Device), foods, and dietary supplements.

REGISTRATION
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Membership dues for 2021 will be $20 for the year.

When your membership renewal comes up during the 2021 calendar year, you will receive, via email, an invoice for $20.
Please pay via the invoice, the old "log in to the website and renew" is no longer available.

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2020 RAC Workshops: Self Learning

REGISTRATION REMAINS OPEN. 

Matierials and Recordings are available for each workshop to those registered.

Each series is a separate registration and fee!

Please don't try to tackle both at the same time.  Seriously.  Just pick ONE.

Pharma/Bio (or) Devices

Workshops Syllabus
REGISTER DEVICES
REGISTER PHARMA/BIO

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