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1

Strengthening of regulatory systems for medicines in the Americas

by Carissa Etienne, Robert Califf

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2

Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings

by Harinder Singh Chahal, Farrah Kashfipour, Matt Susko, Neelam Sekhri Feachem, Colin Boyle
“...ABSTRACT Medicines Regulatory Authorities (MRAs) are an essential part of national health systems...”

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3

Sharing regulatory data as tools for strengthening health systems in the Region of the Americas

by Varley Dias Sousa, Pedro I. Ramalho, Dâmaris Silveira
“...ABSTRACT Regulatory transparency is an imperative characteristic of a reliable National Regulatory...”

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4

Regulatory convergence and harmonization: barriers to effective use and adoption of common standards

by María Luz Pombo, Analía Porrás, Patricia Claudia Saidon, Stephanie M Cascio
“...) published by the Pan American Network for Drug Regulatory Harmonization (PANDRH) member states and 2...”

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5

Strengthening the regulatory system through the implementation and use of a quality management system

by Reinhold Eisner, Rakeshkumar Patel
Published 2017
“... management system and describes how the regulatory system was improved as a result of this project. BGTD...”

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6

Regulatory transparency: social, technical, and ethical aspects of clinical trial data access

by Varley Dias Sousa, Dâmaris Silveira
Published 2015
“... developments in public policy regarding regulatory transparency, and the risks and benefits of a regulatory...”

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7

Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries

by Carlos E. Durán, Martín Cañás, Martín A. Urtasun, Monique Elseviers, Tatiana Andia, Robert Vander Stichele, Thierry Christiaens
Published in Revista Panamericana de Salud Pública (2021)
“...Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean...”

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8

An international comparative analysis of public reimbursement of orphan drugs in Canadian provinces compared to European countries

by Leanne Marie Ward, Alexandra Chambers, Emine Mechichi, Durhane Wong-Rieger, Craig Campbell
Published in Orphanet Journal of Rare Diseases (2022)
Subjects: “...Regulatory approval...”

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9

Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM member states

by Charles Preston, Harinder S. Chahal, Analia Porrás, Lucette Cargill, Maryam Hinds, Babatunde Olowokure, Rudolph Cummings, James Hospedales
“... regulatory systems strengthening is particularly challenging in resource-constrained settings...”

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10

Regulatory measures to fight obesity in Small Island Developing States of the Caribbean and Pacific, 2015 – 2017

by Nicole Foster, Anne Marie Thow, Nigel Unwin, Miriam Alvarado, T. Alafia Samuels
Published in Revista Panamericana de Salud Pública (2018)
“..., Dominica, Jamaica, and in the Pacific— Fiji, Nauru, and Tonga with specific governmental regulatory...”

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11

Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas

by Martin Harvey Allchurch, Dirceu Brás Aparecido Barbano, Marie-Hélène Pinheiro, Janis Lazdin-Helds
“...ABSTRACT This report considers how the experience of the European regulatory system might...”

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12

Comparative analysis of the myoglobin gene in whales and humans reveals evolutionary changes in regulatory elements and expression levels.

by Charles Sackerson, Vivian Garcia, Nicole Medina, Jessica Maldonado, John Daly, Rachel Cartwright
Published in PLOS ONE (2023)
“... expression by exercise, hypoxia, and other physiological gene regulatory pathways. Here we explore...”

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13

The regulatory role of GABAA receptor in Actinia equina nervous system and the possible effect of global ocean acidification

by Snigirov, Sergii, Sylantyev, Sergiy
Published in Pflügers Archiv - European Journal of Physiology (2021)

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14

Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America

by Ivar T. van der Zee, Rick A. Vreman, Lawrence Liberti, Mario Alanis Garza
Published in Revista Panamericana de Salud Pública (2022)
Subjects: “...regulatory frameworks...”

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15

Compliance with vessel speed restrictions to protect North Atlantic right whales

by Gregory K. Silber, Jeffrey D. Adams, Christopher J. Fonnesbeck
Published in PeerJ (2014)
Subjects: “...Regulatory compliance...”

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16

Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use...

by Lauren White, Zulma Ortiz, Luis G Cuervo, Ludovic Reveiz
Published 2011
“...OBJECTIVE: To review and analyze the regulatory framework of clinical trial registration, use...”

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17

Substandard, falsified and unregistered medicines in Latin America, 2017-2018

by Robin Rojas-Cortés
Published in Revista Panamericana de Salud Pública (2020)
“... incidents were detected, quality deviations identified in tested samples, and regulatory measures taken...”

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18

A SLC4 family bicarbonate transporter is critical for intracellular pH regulation and biomineralization in sea urchin embryos

by Marian Y Hu, Jia-Jiun Yan, Inga Petersen, Nina Himmerkus, Markus Bleich, Meike Stumpp
Published in eLife (2018)
“... but with the underlying pH regulatory mechanisms remaining largely unknown. Using the sea urchin larva, this work...”

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19

Identification of conserved and novel microRNAs in the Pacific oyster Crassostrea gigas by deep sequencing.

by Fei Xu, Xiaotong Wang, Yue Feng, Wen Huang, Wei Wang, Li Li, Xiaodong Fang, Huayong Que, Guofan Zhang
Published in PLoS ONE (2014)
“...MicroRNAs (miRNAs) play important roles in regulatory processes in various organisms. To date many...”

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20

Myo-inositol phosphate synthase expression in the European eel (Anguilla anguilla) and Nile tilapia (Oreochromis niloticus) : effect of seawater acclimation

by Kalujnaia, Svetlana, Hazon, Neil, Cramb, Gordon
Published in American Journal of Physiology-Regulatory, Integrative and Comparative Physiology (2016)

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