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Less than Perfect? Clinical Efficacy Data Supporting Approval of New Drugs: Focus on Approvals Based on a Single Pivotal Trial

Track:
Content Hub Sessions

Day & Time:
April 18, 11:15AM - 11:45AM (Central Europe Standard Time)

Session Number:
CH02

Room Number:
Innovation Theatre

Type:
Session

Title:
Less than Perfect? Clinical Efficacy Data Supporting Approval of New Drugs: Focus on Approvals Based on a Single Pivotal Trial

Chair(s):
Anne Vinther Morant, PhD, MSc
Senior Specialist, Regulatory Science & Advocacy
H. Lundbeck A/S, Denmark

Description:
Less than Perfect? Clinical Efficacy Data Supporting Approval of New Drugs: Focus on Approvals Based on a Single Pivotal Trial