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Patient Focus as Part of the Regulatory Affairs DNA: Opportunities and Challenges
Session Chair(s)
Max Wegner, PharmD, RPh
Head Regulatory Affairs
Bayer AG, Germany
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 Objective : 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.
Speaker(s)
FDA Perspective
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
Patient Representative
Marc M. Boutin, JD
Novartis , Switzerland
Global Head of Patient Engagement and Advocacy
Industry Perspective
Miu Chau, PhD
Genentech, A Member of the Roche Group, United States
Senior Regulatory Program Director
Patient Representative
Jill Bonjean, MSc
Rare Diseases International, France
Corporate Relations Advisor
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