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

Reference

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  2. 2.↵
    PDA Points to Consider: Technical Product Lifecycle Management Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities, http://journal.pda.org/content/early/2017/01/14/pdajpst.2016.007492.full.pdf+html.
  3. 3.↵
    PDA Points to Consider: Technical Product Lifecycle Management Pharmaceutical Quality System (PQS) Effectiveness for Managing Post Approval Change, http://journal.pda.org/content/early/2017/02/14/pdajpst.2017.007575.full.pdf+html.
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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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