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Research ArticlePDA Paper

PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?

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, Kara Follman, Karolyn Gale, Kassidy Good, Suzanne Kiani, Maik Jornitz, Morten Munk, Kevin O'Donnel, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther, Denyse Baker and Rich Levy
PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 421-427; DOI: https://doi.org/10.5731/pdajpst.2017.008219
Emma Ramnarine
Genentech
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Ursula Busse
Novartis
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Marcello Colao
GlaxoSmithKline Biologicals
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Julia Edwards
Allergan
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Kara Follman
Pfizer
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Karolyn Gale
Emergent BioSolutions
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Kassidy Good
Mylan Laboratories
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Suzanne Kiani
Mylan Laboratories
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Maik Jornitz
G-Con Manufacturing Inc.
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Morten Munk
NNE Pharmaplan
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Kevin O'Donnel
HPRA
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Melissa Seymour
Biogen
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  • For correspondence: Melissa.seymour@biogen.com
Mihaela Simianu
Pharmatech
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Lisa Skeens
Pfizer
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Anders Vinther
Sanofi-Pasteur
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Denyse Baker
PDA
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Rich Levy
PDA
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  • Article
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Article Information

vol. 71 no. 5 421-427
DOI 
https://doi.org/10.5731/pdajpst.2017.008219
PubMed 
28819050

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 11, 2017.

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  • previous version (August 17, 2017 - 18:10).
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© PDA, Inc. 2017

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PDA Journal of Pharmaceutical Science and Technology: 71 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 5
September/October 2017
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PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?
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, Kara Follman, Karolyn Gale, Kassidy Good, Suzanne Kiani, Maik Jornitz, Morten Munk, Kevin O'Donnel, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther, Denyse Baker, Rich Levy
PDA Journal of Pharmaceutical Science and Technology Sep 2017, 71 (5) 421-427; DOI: 10.5731/pdajpst.2017.008219

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PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?
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, Kara Follman, Karolyn Gale, Kassidy Good, Suzanne Kiani, Maik Jornitz, Morten Munk, Kevin O'Donnel, Melissa Seymour, Mihaela Simianu, Lisa Skeens, Anders Vinther, Denyse Baker, Rich Levy
PDA Journal of Pharmaceutical Science and Technology Sep 2017, 71 (5) 421-427; DOI: 10.5731/pdajpst.2017.008219
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  • Article
    • Introduction
    • Summary
    • Participation
    • Most PACs Reflect the Need to Manage Capacity, Innovate
    • Complexity—Timelines and Product Variants Contribute to Inventory Segmentation/Drug Shortage
    • Time Required for PACs
    • Post-Approval Change Management Protocols (PACMPs) May Help Lessen the Burden
    • Impact on Drug Shortage, Compliance, Innovation
    • Conclusions
    • Conflict of Interest Statement
    • Footnotes
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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