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Akademický článek

Guided Imagery: A Technique to Benefit Youth at Risk

Autor: Lisa Skeens

Publikováno v: National Youth Advocacy and Resilience Journal, Vol 2, Iss 2 (2017)

Guided imagery is a valuable intervention strategy that can benefit children who are at risk for social, academic, and mental health problems. Guided imagery is a technique that employs imagination, emotions, and a spectrum of bodily senses (Naparste

Externí odkaz: https://doaj.org/article/e905f383f3ca4c069996dcc7da4c2e49

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

Autor: Lisa Skeens, Morten Munk, Marcello Colao, Melissa Seymour, Ursula Busse, Julia Edwards, Mihaela Simianu, Maik Jornitz, Emma Ramnarine, Anders Vinther

Publikováno v: PDA Journal of Pharmaceutical Science and Technology. 71:163-169

Changes occur throughout a product's commercial life—changes in raw materials, manufacturing equipment, processes, sites, analytical methods, and suppliers. A product Marketing Authorization Holder (MAH) can introduce manufacturing changes as part

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3deda6accf6937920e1287713f6b154a
https://doi.org/10.5731/pdajpst.2016.007492

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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?

Autor: Rich Levy, Anders Vinther, Suzanne Kiani, Lisa Skeens, Marcello Colao, Ursula Busse, Kevin O'Donnel, Julia Edwards, Denyse Baker, Karolyn Gale, Mihaela Simianu, Morten Munk, Kara Follman, Kassidy Good, Melissa Seymour, Maik Jornitz, Emma Ramnarine

Publikováno v: PDA Journal of Pharmaceutical Science and Technology. 71:421-427

PDA's PAC iAM (Post-Approval Change: Innovation for Availability of Medicines) program has been established with the objective to identify, assess, and address current barriers to implementation of post-approval changes (PACs) that are intended to en

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e66df7f1caa9ae01d6e74750f9e81092
https://doi.org/10.5731/pdajpst.2017.008219

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PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes

Autor: Morten Munk, Anders Vinther, Marcello Colao, Ursula Busse, Emma Ramnarine, Kevin O'Donnell, Lisa Skeens, Mihaela Simianu, Julia Edwards, Maik Jornitz, Melissa Seymour

Publikováno v: PDA journal of pharmaceutical science and technology. 71(3)

The International Council for Harmonisation Quality Guideline 10 (ICH Q10) describes the Pharmaceutical Quality System (PQS), indicating it is intended to apply throughout a product9s lifecycle, in conjunction with good manufacturing practice (GMP) r

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ef72023fc827096a53cf93283e4bdcd5
https://pubmed.ncbi.nlm.nih.gov/28196929

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