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Tuesday, June 25 • 8:00am - 9:15am
#208: Patient Focus as Part of the Regulatory Affairs DNA: Opportunities and Challenges

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-576-L04-P; CME 1.25; IACET 1.25; RN 1.25

Patients are at the heart of everything we do. Integrating patient focus into the regulatory mindset can be a challenge. Panelists will discuss their experiences, share best practices, and describe challenges in achieving this goal.

Learning Objectives

Identify best practices for integrating a patient focus mindset into the regulatory affairs organization; Recognize challenges faced by leaders in achieving this goal; Describe experiences with implementing patient focused practices as part of regulatory strategies.

Chair

Max Wegner, PharmD, RPh

Speaker

FDA Perspective
Theresa Mullin, PhD

Patient Representative
Marc M. Boutin, JD

Industry Perspective
Miu Chau, PhD

Patient Representative
Jill Bonjean, MSc



Speakers
avatar for Jill Bonjean

Jill Bonjean

Corporate Relations Advisor, Rare Diseases International
Jill Bonjean is Corporate Relations Advisor for Rare Diseases International - the global alliance of rare disease patient organizations. Jill works with RDI and other patient organizations to build effective relationships with companies and other partners. Previously, she's managed... Read More →
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →
MC

Miu Chau

Senior Regulatory Program Director, Genentech, A Member of the Roche Group
Miu joined Genentech in 2008 and held different roles. Currently she is a Senior Regulatory Program Director responsible for the global regulatory strategy and execution of projects and leading a matrix team of regulatory professionals in oncology. Miu had been the Global Head of... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, OCD, CDER, FDA
Principal advisor on strategy including CDER international cooperation and harmonization, application of decision science, and other initiatives. Leads FDA Patient Focused Drug Development, and heads the FDA delegation to ICH. Previous work includes leading FDA negotiations for 2002... Read More →
avatar for Max Wegner

Max Wegner

Head Regulatory Affairs, Bayer AG
After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA