Follow @ncraf NCRAF is on LinkedIn! North Carolina Regulatory Affairs ForumNCRAF 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. ******************************************************************************************************
Members MeetingFebruary 18, 20216:30 - 8:00 pm via Zoom Global Regulatory StrategiesBirgitta HedinHead, Global Regulatory Affairs - Rare DiseasesChiesi GroupThe 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 REGISTRATION**************************************************************************************************
Members MeetingMarch 18, 20216:30 - 8:00 pm via Zoom Limiting the Clinical Trial to What You Need
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