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Sunday, June 14 • 9:00am - 12:30pm
SC26: #26: “Has it Happened Already?” Questions of Precedent from which Regulatory Intelligence Can Save You

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-20-505-L04-P; CME 3.25; IACET 3.25; RN 3.25

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This intent of this short course is to provide a quick overview and practical insight into locating, analyzing and applying precedent as an aid to making better strategic regulatory decisions. In a rapidly evolving regulatory environment, it is critical for regulatory professionals to employ research skills in locating precedent, determining those that are deemed meaningful and discarding those that are misleading, and developing an understanding of the bigger picture as a critical deliverable in a time of data-driven decision-making.
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Who should attend?

Regulatory affairs, regulatory intelligence and policy professionals, professionals engaged in regulatory research and precedent analysis to support regulatory decision-making.

Learning Objectives

Describe the importance and context of precedent in regulatory strategy; Discuss locating and analyzing precedent from EU and US drug and biologic sources;Identify the impact of precedent for regulatory decision-making.


Speakers
avatar for Linda Bowen

Linda Bowen

Head of Regulatory Policy and Intelligence, Seagen
Linda joined the BioPharma industry in 1983 and has spent the last 28 years in regulatory strategy, intelligence and policy roles. She is Head of Regulatory Policy and Intelligence at Seagen (formerly Seattle Genetics) and Assistant Professor in the Temple University RAQA graduate... Read More →
avatar for João Duarte

João Duarte

Director, Chief of Staff & Regulatory Science, Alexion Pharmaceuticals, France
João Duarte is currently Chief of Staff and Regulatory Science within the Global Regulatory Affairs team at Alexion Pharmaceuticals. João leads the regulatory intelligence and policy activities globally and supports Senior Management in steering internal activities based on the... Read More →


Sunday June 14, 2020 9:00am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  Short Courses, Tutorial |   09: Regulatory, Tutorial