Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry One-Voice-of-Quality (1VQ) Solutions

Emma Ramnarine; Anders Vinther; Kimberly Bruhin; Christina Tovar; Marcello P Colao

doi:10.5731/pdajpst.2020.011734

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Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry One-Voice-of-Quality (1VQ) Solutions

Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello P Colao

PDA Journal of Pharmaceutical Science and Technology May 2020, pdajpst.2020.011734; DOI: https://doi.org/10.5731/pdajpst.2020.011734

Emma Ramnarine

1 Roche;

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For correspondence: eramnar@gene.com

Anders Vinther

2 Intarcia Therapeutics, Inc.;

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For correspondence: anders.vinther@intarcia.com

Kimberly Bruhin

3 Johnson & Johnson;

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For correspondence: kbruhin1@its.jnj.com

Christina Tovar

3 Johnson & Johnson;

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For correspondence: ctovar@its.jnj.com

Marcello P Colao

4 GSK

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For correspondence: marcello.x.colao@gsk.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 76, Issue 2

March/April 2022

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Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry One-Voice-of-Quality (1VQ) Solutions

Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar, Marcello P Colao

PDA Journal of Pharmaceutical Science and Technology May 2020, pdajpst.2020.011734; DOI: 10.5731/pdajpst.2020.011734

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Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry One-Voice-of-Quality (1VQ) Solutions