Worldwide Regulatory Reliance: Launching A Pilot on A Chemistry, Manufacturing and Control Post Approval Change for A Vaccine

Thierry Gastineau; Cynthia Ban; Ana Basso; Franziska Brehme; Ana Luisa Silva; Olivier Faure; Lyne Le Palaire; Priya Persaud; Heraclio Rodriguez

doi:10.5731/pdajpst.2023.012850

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Worldwide Regulatory Reliance: Launching A Pilot on A Chemistry, Manufacturing and Control Post Approval Change for A Vaccine

Thierry Gastineau, Cynthia Ban, Ana Basso, Franziska Brehme, Ana Luisa Silva, Olivier Faure, Lyne Le Palaire, Priya Persaud and Heraclio Rodriguez

PDA Journal of Pharmaceutical Science and Technology November 2023, pdajpst.2023.012850; DOI: https://doi.org/10.5731/pdajpst.2023.012850

Thierry Gastineau

Sanofi

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For correspondence: thierry.gastineau@sanofi.com

Cynthia Ban

Sanofi

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For correspondence: cynthia.ban@sanofi.com

Ana Basso

Sanofi

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For correspondence: ana.basso@sanofi.com

Franziska Brehme

Sanofi

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For correspondence: franziska.brehme@sanofi.com

Ana Luisa Silva

Sanofi

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For correspondence: analuisa.silva@sanofi.com

Olivier Faure

Sanofi

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For correspondence: olivier.faure@sanofi.com

Lyne Le Palaire

Sanofi

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For correspondence: lyne.lepalaire@sanofi.com

Priya Persaud

Sanofi

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For correspondence: priyapersaud@sanofi.com

Heraclio Rodriguez

Sanofi

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For correspondence: heraclio.rodriguez@sanofi.com

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Article Information

pdajpst.2023.012850

DOI

https://doi.org/10.5731/pdajpst.2023.012850

PubMed

37973190

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received March 23, 2023
Accepted October 12, 2023
Published online November 16, 2023.

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You are currently viewing a previous version of this article (November 16, 2023 - 04:45).
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Author Information

Thierry Gastineau (thierry.gastineau{at}sanofi.com),
Cynthia Ban 1 (cynthia.ban{at}sanofi.com),
Ana Basso (ana.basso{at}sanofi.com),
Franziska Brehme (franziska.brehme{at}sanofi.com),
Ana Luisa Silva (analuisa.silva{at}sanofi.com),
Olivier Faure (olivier.faure{at}sanofi.com),
Lyne Le Palaire (lyne.lepalaire{at}sanofi.com),
Priya Persaud (priyapersaud{at}sanofi.com) and
Heraclio Rodriguez (heraclio.rodriguez{at}sanofi.com)

Sanofi

↵* Corresponding author; email: cynthia.ban{at}sanofi.com

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Worldwide Regulatory Reliance: Launching A Pilot on A Chemistry, Manufacturing and Control Post Approval Change for A Vaccine

Thierry Gastineau, Cynthia Ban, Ana Basso, Franziska Brehme, Ana Luisa Silva, Olivier Faure, Lyne Le Palaire, Priya Persaud, Heraclio Rodriguez

PDA Journal of Pharmaceutical Science and Technology Nov 2023, pdajpst.2023.012850; DOI: 10.5731/pdajpst.2023.012850

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Worldwide Regulatory Reliance: Launching A Pilot on A Chemistry, Manufacturing and Control Post Approval Change for A Vaccine

Thierry Gastineau, Cynthia Ban, Ana Basso, Franziska Brehme, Ana Luisa Silva, Olivier Faure, Lyne Le Palaire, Priya Persaud, Heraclio Rodriguez

PDA Journal of Pharmaceutical Science and Technology Nov 2023, pdajpst.2023.012850; DOI: 10.5731/pdajpst.2023.012850

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Keywords

Harmonization,
Post approval change,, Shortage, Vaccines
Regulatory reliance
Shortage
Supply
Vaccine

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