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Research ArticleResearch

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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References

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    Worldwide Regulatory Reliance: Launching A Pilot on A Chemistry, Manufacturing and Control Post Approval Change for A Vaccine. PDA J. Pharm. Sci. Technol. 2024, 78 (4), 388–398.
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    WHO Expert Committee on Biological Standardization. Annex 4: Guidelines on Procedures and Data Requirements for Changes to Approved Vaccines; WHO Technical Report Series No.993; WHO, 2015.
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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 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 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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