Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Research ArticlePDA Paper

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
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: anders.vinther@intarcia.com
Emma Ramnarine
2Roche, 1 DNA Way, South San Francisco, 94080
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 73 no. 5 517-521
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 
  • Published online October 9, 2019.

Article Versions

  • previous version (August 16, 2019 - 04:26).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Anders Vinther1,* and
  2. Emma Ramnarine2
  1. 1Intarcia Therapeutics, 24650 Industrial Boulevard, Hayward, CA 94545; and
  2. 2Roche, 1 DNA Way, South San Francisco, 94080
  1. ↵* Corresponding Author: Intarcia Therapeutics, 24650 Industrial Boulevard, Hayward, CA 94545. Telephone: 510-782-7800; e-mail: anders.vinther{at}intarcia.com
View Full Text

Cited By...

  • Citations
  • Google Scholar

This article has not yet been cited by articles in journals that are participating in Crossref Cited-by Linking.

PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 5
September/October 2019
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
4 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
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

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
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
del.icio.us logo Digg logo Reddit logo Twitter logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Action Proposed
    • Statement of the Perceived Problem
    • Strategic Importance of the Topic
    • Issues to Be Resolved
    • Type of Working Group Recommended
    • Deliverables
    • References
  • Info & Metrics
  • References
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap
  • Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)--through Enhanced Science and Risk-Based Approaches
  • Google Scholar

More in this TOC Section

  • Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data
  • Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
  • Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
Show more PDA Paper

Similar Articles

Keywords

  • Pharmaceuticals
  • Post-approval change
  • ICH Q10
  • Pharmaceutical quality system

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2023 PDA Journal of Pharmaceutical Science and Technology ISSN: 1079-7440

Powered by HighWire