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SESSION 4 B: QUALITY THROUGH COMPLIANCE – PART II: POST-APPROVAL CHANGES
Session Chair(s)
Florence Roizard, PharmD
Associate Vice President, Regulatory Affairs International
MSD France, France
This session will focus on ensuring uninterrupted access and delivering the right drug at the right place at the right time. Promoting global harmonization of standards for regulators, industry and patients
Speaker(s)
Global Challenges of Handling Post-approval Changes and Examples of Agency Collaborations
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
Global Challenges of Handling Post-approval Changes and Examples of Agency Collaborations
Moheb M. Nasr, PhD, MS
Nasr Pharma Regulatory Consulting, United States
Principal
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