Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing and Control Post Approval Change Pilot

Cynthia Ban; Jamie Graham; Lyne Le Palaire; Priya Persaud; Franziska Brehme; Olivier Faure; Allison Rameau; Ana Luisa Silva

doi:10.5731/pdajpst.2024-003023.1

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Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing and Control Post Approval Change Pilot

Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau and Ana Luisa Silva

PDA Journal of Pharmaceutical Science and Technology April 2025, pdajpst.2024-003023; DOI: https://doi.org/10.5731/pdajpst.2024-003023.1

Cynthia Ban

1Sanofi, Global Regulatory CMC, Toronto, Canada

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For correspondence: cynthia.ban@sanofi.com

Jamie Graham

1Sanofi, Global Regulatory CMC, Toronto, Canada

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Lyne Le Palaire

2Sanofi, Global Regulatory Affairs & Quality, Lyon, France

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Priya Persaud

1Sanofi, Global Regulatory CMC, Toronto, Canada

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Franziska Brehme

3Sanofi, Regulatory Affairs, Berlin, Germany

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Olivier Faure

2Sanofi, Global Regulatory Affairs & Quality, Lyon, France

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Allison Rameau

2Sanofi, Global Regulatory Affairs & Quality, Lyon, France

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Ana Luisa Silva

4Sanofi, Regulatory Affairs, Sao Paulo, Brazil

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

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Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing and Control Post Approval Change Pilot

Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau, Ana Luisa Silva

PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2024-003023; DOI: 10.5731/pdajpst.2024-003023.1

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Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing and Control Post Approval Change Pilot

Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau, Ana Luisa Silva

PDA Journal of Pharmaceutical Science and Technology Apr 2025, pdajpst.2024-003023; DOI: 10.5731/pdajpst.2024-003023.1

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Keywords

Post approval change
Regulatory reliance
Harmonization
Supply Continuity
Regulatory Reliance Feasibility
Convergence supply
Vaccines

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