Results 41 to 50 of about 8,452 (228)

Real-world data: principles of use in decision making and in health technology assessment

Фармакоэкономика, 2023
The use of real-world data (RWD) and real-world evidence (RWE) in process of improving public health, their assessment, and use in decision making is a promising area.
V. V. Omelyanovskiy, F. V. Gorkavenko, N. V. Ignatyeva, P. A. Mukhortova, O. R. Ryzhova, T. S. Teptsova, A. A. Kingshott, B. B. Kondratyeva   +7 more
doaj   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Practical implications of using real-world evidence (RWE) in comparative effectiveness research: learnings from IMI-GetReal [PDF]

, 2017
In light of increasing attention towards the use of real-world evidence (RWE) in decision making in recent years, this commentary aims to reflect on the experiences gained in accessing and using RWE for comparative effectiveness research as a part of the
Lees, Michael, Ryll, Bettina, Debray, Thomas P. A.,, Abrams, Keith,, Bettina Ryll, Michael Lees, Goettsch, Wim, Lees, Michael,, Garner, Sarah, Goettsch, Wim,, Stegenga, Heather, Ciaglia, Antonio,, Heather Stegenga, Happich, Michael,, Antonio Ciaglia, Páll Jonsson, Wim Goettsch, Stegenga, Heather,, Jonsson, Páll, Makady, Amr, Amr Makady, Keith Abrams, Garner, Sarah,, Sarah Garner, Abrams, Keith, Debray, Thomas P.A., Michael Happich, Ciaglia, Antonio, Makady, Amr,, Rob Thwaites, Thwaites, Rob, Ryll, Bettina,, Thwaites, Rob,, Jonsson, Pall,, Thomas PA Debray, Happich, Michael   +35 more
core   +5 more sources

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

RWE 1 [PDF]

, 2010
The World's Reactors, No. 14, RWE 1, Dettingen, near Frankfurt-Main.
Nuclear Engineering International
core  

ICH Reflection paper on proposed international harmonization of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of drugs

Реальная клиническая практика: данные и доказательства, 2023
Real-world data and real-world evidence play an increasingly important role in clinical research and healthcare decisionmaking. To use data and generate robust evidence effectively, they must be clearly defined and structured, semantically compatible and
K. S. Radaeva, R. R. Niyazov
doaj   +1 more source

The Role of Transition Intermediaries as Capability Builders for Adopting Radical Innovation in Incumbent Firms: The Case of the UK Energy Supply Sector

Business Strategy and the Environment, EarlyView.
ABSTRACT Transition intermediaries play a pivotal role in configuring networks aligning the interests of stakeholders to achieve sustainable goals. However, the transition literature has paid little attention to the influence intermediaries can have in strengthening organisational capabilities. Especially in sectors that are slow to change, such as the
Horacio Gonzalez, Matthew Hannon, Efstathios Tapinos   +2 more
wiley   +1 more source

Umweltschutz bei RWE 1996 [PDF]

, 1996
Umwelt- und Ressourcenschonung sind Ziele, die in der politischen Diskussion und im Handeln der Unternehmen eine immer groessere Bedeutung gewinnen. Dies gilt uneingeschraenkt auch fuer alle Unternehmensbereiche des RWE-Konzerns -Energie, Bergbau und ...
Rheinisch-Westfaelisches Elektrizitaetswerk AG, Essen (Germany)
core  

RWE AG (Rheinisch Westfälisches Elektrizitätswerk AG) [PDF]

, 2000
Lorrain Dominique. RWE AG (Rheinisch Westfälisches Elektrizitätswerk AG). In: Flux, n°39-40, 2000. pp.
Lorrain, Dominique, Dominique Lorrain
core   +1 more source