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Developing and Maintaining Sponsor/CRO Partnership Regulatory Submissions Processes: Challenges and Successes
Session Chair(s)
Bill Leslie
Head, Global Regulatory Operations
Covance Inc., United States
Over four years ago, Merck selected Covance and PAREXEL as alliance partners. Representatives from each company will speak to challenges faced in building relationships leading to successful processes and enabling quality regulatory submissions.
Learning Objective : Identify challenges to consider in developing partnership processes; Discuss recommendations on how to meet these challenges based on experience.
Speaker(s)
Sponsor/CRO Partnership Regulatory Submissions Processes: Sponsor Perspective
Denise Booker, MS
Merck & Co., Inc., United States
Associate Director and Relationship Manager
Sponsor/CRO Partnership Regulatory Submissions Processes: CRO Perspective
Ulrike Behr, MSc
PAREXEL International GmbH, Germany
Director, Regulatory Affairs
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