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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.
Ramnarine E, Vinther A, Bruhin K, Tovar C, Colao M. Ramnarine E, et al. Among authors: vinther a. PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):456-467. doi: 10.5731/pdajpst.2020.011734. Epub 2020 May 28. PDA J Pharm Sci Technol. 2020. PMID: 32467177
Post-approval changes are inevitable and necessary throughout the life of a drug product-to implement new knowledge, maintain a state of control, and drive continual improvement. ...The Chief Quality Officers/Heads of Quality are inviting other companies to join the …
Post-approval changes are inevitable and necessary throughout the life of a drug product-to implement new knowledge, maintain a …
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); Ramnarine E, Busse U, Colao M, Edwards J, Jornitz M, Munk M, Seymour M, Simianu M, Skeens L, Vinther A. Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), et al. Among authors: vinther a. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):163-169. doi: 10.5731/pdajpst.2016.007492. Epub 2017 Jan 15. PDA J Pharm Sci Technol. 2017. PMID: 28089963 Review. No abstract available.
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); Ramnarine E, Busse U, Colao M, Edwards J, O'Donnell K, Jornitz M, Munk M, Seymour M, Simianu M, Skeens L, Vinther A. Authors: Members of the PDA Task Force on Post-approval Changes for Innovation in Availability of Medicines (PAC iAMsm), et al. Among authors: vinther a. PDA J Pharm Sci Technol. 2017 May-Jun;71(3):252-258. doi: 10.5731/pdajpst.2017.007575. Epub 2017 Feb 14. PDA J Pharm Sci Technol. 2017. PMID: 28196929 Review. No abstract available.
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); Ramnarine E, Busse U, Colao M, Edwards J, Follman K, Gale K, Good K, Kiani S, Jornitz M, Munk M, O'Donnel K, Seymour M, Simianu M, Skeens L, Vinther A, Baker D, Levy R. Authors: Members of the PDA Task Force Post Approval Changes for Innovation in Availability of Medicines (PAC iAM), et al. Among authors: vinther a. PDA J Pharm Sci Technol. 2017 Sep-Oct;71(5):421-427. doi: 10.5731/pdajpst.2017.008219. Epub 2017 Aug 17. PDA J Pharm Sci Technol. 2017. PMID: 28819050 No abstract available.
91 results