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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

The Financial, Resource and Planning Challenges of Incorporation of Mandatory Language into Protocols

Session Chair(s)

Anne  Cropp, PharmD

Anne Cropp, PharmD

Chief Scientific Officer

Early Access Care LLC, United States

Benchmarking the Clinical Budget and Outsourcing Processes

Learning Objective : Discuss the impact of regulatory-mandated protocol amendments have to organizations; List the considerations that can be used for internal planning or CRO partner guidance; Describe the communication needed to various stakeholders.

Speaker(s)

Anne  Cropp, PharmD

Lessons Learned from Recent Implementation of Legislation-Required Safety Language into Protocols: Cost, People, Planning

Anne Cropp, PharmD

Early Access Care LLC, United States

Chief Scientific Officer

Badri  Rengarajan, MD

Use of Virtual Population Simulation to Improve Protocol Design and Amendment Management

Badri Rengarajan, MD

Jazz Pharmaceuticals, United States

Life Sciences

Stella  Stergiopoulos, MPH, MS

Benchmarking the Clinical Budget and Outsourcing Processes

Stella Stergiopoulos, MPH, MS

EQRx, United States

Director, Health Economic and Outcomes Research

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