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Research ArticlePDA Papers

PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities

Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 163-169; DOI: https://doi.org/10.5731/pdajpst.2016.007492
Emma Ramnarine
Genentech
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  • For correspondence: eramnar@gene.com
Ursula Busse
Novartis
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Marcello Colao
GlaxoSmithKline Biologicals
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Julia Edwards
Biogen
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Maik Jornitz
G-Con Manufacturing Inc.
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Morten Munk
NNE Pharmaplan
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Melissa Seymour
Biogen
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Mihaela Simianu
Consultant
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Lisa Skeens
Pfizer
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Anders Vinther
Sanofi-Pasteur
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  • Article
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References

  1. 1.↵
    Quality Guideline Q10: Pharmaceutical Quality System. ICH, 2010. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed August 2016).
  2. 2.↵
    ICH Q12 concept paper. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Concept_Paper_July_2014.pdf (accessed August 2016).
  3. 3.↵
    ICH Q12 business plan. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_Final_Buisness_Plan_July_2014.pdf (accessed August 2016).
  4. 4.↵
    Quality Guideline Q8(R2): Pharmaceutical Development. ICH, 2009. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf (accessed August 2016).
  5. 5.↵
    Quality Guideline Q9: Quality Risk Management. ICH, 2006. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed August 2016).
  6. 6.↵
    Quality Guideline Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). ICH, 2012. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed August 2016).
  7. 7.↵
    1. Ohage E.,
    2. Iverson R.,
    3. Krummen L.,
    4. Taticek R.,
    5. Vega M.
    QbD Implementation and Post Approval Lifecycle Management (PALM). Biologicals 2016, 44 (5), 332–340.
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
March/April 2017
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PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 163-169; DOI: 10.5731/pdajpst.2016.007492

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PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities
Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 163-169; DOI: 10.5731/pdajpst.2016.007492
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Jump to section

  • Article
    • Introduction
    • Background
    • Why Is Product Lifecycle Management Important?
    • Elements of a Lifecycle Management Strategy
    • Lifecycle Management for Legacy Products
    • Benefits of Proactively Sharing Lifecycle Management Strategy With Health Authorities
    • Conclusion
    • Glossary
    • Conflict of Interest Statement
    • References
  • Figures & Data
  • Info & Metrics
  • References
  • PDF

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More in this TOC Section

  • Achieving “Zero” Defects for Visible Particles in Injectables
  • Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
  • PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
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