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SESSION 4 B: QUALITY THROUGH COMPLIANCE – PART II: POST-APPROVAL CHANGES
Session Chair(s)
Florence Roizard, PHARMD
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)
Susanne Ausborn, PHD
Global Head International Regulatory Policy, Roche, Switzerland
Global Challenges of Handling Post-approval Changes and Examples of Agency Collaborations
Moheb M. Nasr, PHD, MS
Principal, Nasr Pharma Regulatory Consulting, United States
Global Challenges of Handling Post-approval Changes and Examples of Agency Collaborations
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