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PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes
Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia Edwards, Kevin O'Donnell, Maik Jornitz, Morten Munk, Melissa Seymour, Mihaela Simianu, Lisa Skeens and Anders Vinther
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 252-258; DOI: https://doi.org/10.5731/pdajpst.2017.007575