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Research ArticleResearch

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 July 2024, 78 (4) 388-398; DOI: https://doi.org/10.5731/pdajpst.2023.012850
Thierry Gastineau
1Sanofi, Lyon, France;
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Cynthia Ban
2Sanofi, Toronto, Canada;
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  • For correspondence: Cynthia.ban@sanofi.com
Ana Basso
1Sanofi, Lyon, France;
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Franziska Brehme
3Sanofi, Berlin, Germany;
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Ana Luisa Silva
4Sanofi, Sao Paulo, Brazil; and
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Olivier Faure
1Sanofi, Lyon, France;
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Lyne Le Palaire
1Sanofi, Lyon, France;
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Priya Persaud
2Sanofi, Toronto, Canada;
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Heraclio Rodriguez
5Sanofi, Panama City, Panama
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Article Information

vol. 78 no. 4 388-398
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 
  • Published online August 23, 2024.

Article Versions

  • previous version (November 16, 2023 - 04:45).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2024

Author Information

  1. Thierry Gastineau1,
  2. Cynthia Ban2,*,
  3. Ana Basso1,
  4. Franziska Brehme3,
  5. Ana Luisa Silva4,
  6. Olivier Faure1,
  7. Lyne Le Palaire1,
  8. Priya Persaud2 and
  9. Heraclio Rodriguez5
  1. 1Sanofi, Lyon, France;
  2. 2Sanofi, Toronto, Canada;
  3. 3Sanofi, Berlin, Germany;
  4. 4Sanofi, Sao Paulo, Brazil; and
  5. 5Sanofi, Panama City, Panama
  1. ↵* Corresponding Author: 1755 Steeles Ave W, North York, Canada; Telephone: +1 647 883 4183; E-mail: Cynthia.ban@sanofi.com
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    Therapeutic Innovation & Regulatory Science 2024 58 6
  • A Global Industry Survey on Post-Approval Change Management and Use of Reliance
    Andrew Deavin, Aliyah Hossain, Isabelle Colmagne-Poulard, Kum Cheun Wong, Mónica Perea-Vélez, Sonia Cappellini, Susanne Ausborn, Sylvie Meillerais, Céline Bourguignon
    Therapeutic Innovation & Regulatory Science 2024 58 6
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PDA Journal of Pharmaceutical Science and Technology: 78 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 4
July/August 2024
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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 Jul 2024, 78 (4) 388-398; DOI: 10.5731/pdajpst.2023.012850
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Keywords

  • Post approval change
  • Regulatory reliance
  • Harmonization
  • Convergence supply
  • Shortage
  • Vaccines

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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 Jul 2024, 78 (4) 388-398; DOI: 10.5731/pdajpst.2023.012850

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