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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Article Information

pdajpst.2024-003023

DOI

https://doi.org/10.5731/pdajpst.2024-003023.1

PubMed

40300810

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received October 11, 2024
Accepted April 15, 2025
Published online April 29, 2025.

Author Information

Cynthia Ban (cynthia.ban{at}sanofi.com)1,
Jamie Graham1,
Lyne Le Palaire2,
Priya Persaud1,
Franziska Brehme3,
Olivier Faure2,
Allison Rameau2 and
Ana Luisa Silva4

¹Sanofi, Global Regulatory CMC, Toronto, Canada
²Sanofi, Global Regulatory Affairs & Quality, Lyon, France
³Sanofi, Regulatory Affairs, Berlin, Germany
⁴Sanofi, Regulatory Affairs, Sao Paulo, Brazil

Name: Cynthia Ban, Address of correspondence: 1755 Steeles Ave W, North York, ON M2R 3T4 Canada, Email: Cynthia.ban{at}sanofi.com Secondary Email : Cynthiab1{at}live.ca Phone: +1 647 883 4183

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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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