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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Postapproval Change Management: Challenges and Opportunities

Session Chair(s)

Christine  Moore, PhD

Christine Moore, PhD

Executive Director, Global External Advocacy and Standards

Organon & Co., United States

Postapproval Change Management Protocols: Facilitating Regulatory Flexibility

Learning Objective : Describe the importance of a robust change management system; Discuss the challenges and opportunities in maintaining and utilizing a robust global change management system.

Speaker(s)

Evdokia  Korakianiti, PhD, MSc

Postapproval Change Management Protocols: Facilitating Regulatory Flexibility

Evdokia Korakianiti, PhD, MSc

European Medicines Agency, Netherlands

Head of Quality and Safety of Medicines

Christine  Moore, PhD

Post-approval Change Management: Challenges and Opportunities – An FDA Perspective

Christine Moore, PhD

Organon & Co., United States

Executive Director, Global External Advocacy and Standards

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