Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management

Anders Vinther; Emma Ramnarine

doi:10.5731/pdajpst.2019.010827

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Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management

Anders Vinther and Emma Ramnarine

PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 517-521; DOI: https://doi.org/10.5731/pdajpst.2019.010827

Anders Vinther

1Intarcia Therapeutics, 24650 Industrial Boulevard, Hayward, CA 94545; and

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For correspondence: anders.vinther@intarcia.com

Emma Ramnarine

2Roche, 1 DNA Way, South San Francisco, 94080

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vol. 73 no. 5 517-521

DOI

https://doi.org/10.5731/pdajpst.2019.010827

PubMed

31420505

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Parenteral Drug Association (PDA)

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1079-7440

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1948-2124

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Published online October 9, 2019.

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previous version (August 16, 2019 - 04:26).
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Anders Vinther1,* and
Emma Ramnarine2

¹Intarcia Therapeutics, 24650 Industrial Boulevard, Hayward, CA 94545; and
²Roche, 1 DNA Way, South San Francisco, 94080

↵* Corresponding Author: Intarcia Therapeutics, 24650 Industrial Boulevard, Hayward, CA 94545. Telephone: 510-782-7800; e-mail: anders.vinther{at}intarcia.com

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Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management

Anders Vinther, Emma Ramnarine

PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 517-521; DOI: 10.5731/pdajpst.2019.010827

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Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management

Anders Vinther, Emma Ramnarine

PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 517-521; DOI: 10.5731/pdajpst.2019.010827

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Pharmaceuticals
Post-approval change
ICH Q10
pharmaceutical quality system

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