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 May 2025, 79 (3) 295-302; 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; and

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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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vol. 79 no. 3 295-302

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

Published online June 2, 2025.

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previous version (April 29, 2025 - 09:48).
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Author Information

Cynthia Ban¹,*,
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; and
⁴Sanofi, Regulatory Affairs, Sao Paulo, Brazil

↵*Corresponding Author: 1755 Steeles Ave W, North York, ON M2R 3T4 Canada; Telephone: +1 647 883 4183; E-mail: Cynthia.ban{at}sanofi.com

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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 May 2025, 79 (3) 295-302; 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 May 2025, 79 (3) 295-302; 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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