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Monday, June 21 • 9:30am - 12:30pm
013A: #013A: “Has it Happened Already?” Questions of Precedent from which Regulatory Intelligence Can Save You

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Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-502-L04-P; CME 2.75; IACET 2.75; RN 2.75

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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.Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
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Who should attend?

This short course is designed for members involved in: 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.

avatar for Linda Bowen

Linda Bowen

Head of Global Regulatory Policy and Intelligence, Seagen Inc., United States
Linda joined the BioPharma industry in 1983 and has spent the last 29 years in regulatory strategy, intelligence and policy roles. She is Global Head of Regulatory Policy and Intelligence at Seagen Inc. and Assistant Professor in the Temple University RAQA graduate program. She attained... Read More →
avatar for João Duarte

João Duarte

Director, Business Planning & Operations, Global Regulatory Affairs, R&D and Com, Alexion, Astrazeneca Rare Disease, France
João Duarte is currently Director, Business Planning & Operations at Alexion, AstraZenenca Rare Disease. João serves as Chief of Staff to the Head of Regulatory & Quality Affairs and leads regulatory policy activities within the team. He held several roles since 2012 in Regulatory... Read More →

Monday June 21, 2021 9:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial