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 August 2019, pdajpst.2019.010827; DOI: https://doi.org/10.5731/pdajpst.2019.010827

Anders Vinther

1 Intarcia;

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For correspondence: anders.vinther@intarcia.com

Emma Ramnarine

2 Roche

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For correspondence: eramnar@gene.com

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pdajpst.2019.010827

DOI

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

PubMed

31420505

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received August 9, 2019
Accepted August 15, 2019
Published online August 16, 2019.

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Author Information

Anders Vinther1,3 (anders.vinther{at}intarcia.com) and
Emma Ramnarine2 (eramnar{at}gene.com)

¹ Intarcia;
² Roche

↵* Corresponding author; email: 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 Aug 2019, pdajpst.2019.010827; 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 Aug 2019, pdajpst.2019.010827; DOI: 10.5731/pdajpst.2019.010827

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Keywords

ICH Q10
Pharmaceuticals
pharmaceutical quality system
Post-approval change

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