Zobrazeno 1 - 10 of 24 pro vyhledávání: '"ALBERTO GRIGNOLO"'
1
Akademický článek
Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative.
Autor: Alexander R Giaquinto, Alberto Grignolo, Lawrence Liberti, John C W Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu
Publikováno v: PLoS Medicine, Vol 17, Iss 8, p e1003092 (2020)
Alexander Giaquinto and co-authors discuss the East African Community's Medicines Regulatory Harmonization initiative.
Externí odkaz: https://doaj.org/article/6aea43aca56d457aade0303ba75b9eff
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2
Akademický článek
The Clinical Trials Transformation Initiative (CTTI)
Autor: Alberto Grignolo
Publikováno v: Annali dell'Istituto Superiore di Sanità, Vol 47, Iss 1, Pp 14-18 (2011)
The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the qual
Externí odkaz: https://doaj.org/article/34d4f232b4744cf5904a69591a1a5d5d
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4
Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access Strategies
Autor: Alberto Grignolo, Zhang Mingping
Publikováno v: Therapeutic Innovation & Regulatory Science. 52:514-522
Sweeping reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign pharmaceutical companies. Japan, South Korea, and China are leading the charge, establishing mechanisms and infras
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4f5fe0fa7238260c3c610a49cd1dc79f
https://doi.org/10.1177/2168479018769296
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5
Improving Drug Development and Patient Access With the Right People, Processes, and Culture: What Needs to Happen Right Now to Bring Better Medicines to the Patients Who Need Them
Autor: Alberto Grignolo, Albert Siu
Publikováno v: Therapeutic innovationregulatory science. 53(3)
In a global environment where health care costs are soaring, RD efforts are flatlining. Meanwhile, payers are demanding more value for their money. In this environment, the traditional siloed drug development model is not sustainable. Yet innovations
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::40a353419c2d18954b470ec645dd2499
https://pubmed.ncbi.nlm.nih.gov/30526020
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6
Collaboration and Convergence: Bringing New Medicines to Global Markets in the 21st Century
Autor: Alberto Grignolo
Publikováno v: Therapeutic Innovation & Regulatory Science. 47:8-15
In the coming years, the drug development process is likely to change dramatically as manufacturers, regulators, and payers across the world face intense pressure to meet the growing needs of their constituents. Higher hurdles in the regulatory and p
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::125d8c40747898b90d5d575bb3fe3a23
https://doi.org/10.1177/2168479012469951
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7
Organization and Responsibilities of the Chemistry, Manufacturing, and Controls Function within Regulatory Affairs: A Survey of 17 Companies
Autor: Samuel T. Barnett, Roger W. Croswell, Alberto Grignolo, Anthony C. Cartwright
Publikováno v: Drug Information Journal. 32:385-392
To facilitate management of the technical and regulatory Chemistry Manufacturing and Controls (CMC) issues within core dossiers, companies have turned to a range of organizational structures and procedures to manage the input most effectively. The ob
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::050485af54280ef134f4b0d5a1f537a8
https://doi.org/10.1177/009286159803200210
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9
The Development of Orphan Drugs
Autor: Alberto Grignolo
Approximately 25 million Americans and many more throughout the world suffer from more than 6000 rare diseases. Some of these diseases are wellrecognized, such as Lou Gehrig’s disease or cystic fibrosis, but little is known about many others, such
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::9e66891e2a6c2aecf7f42d3319ffb42e
https://doi.org/10.3109/9781420073553-7
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