Results 121 to 130 of about 18,113,311 (279)

Driving continuous improvement of sustainability certification for industrial biobased systems through comprehensive sustainability requirements

Biofuels, Bioproducts and Biorefining, EarlyView.
Abstract Existing monitoring frameworks for sustainability certification schemes and labels (CSLs) have largely prioritised environmental aspects, while the social and economic pillars of sustainability remain comparatively underdeveloped. Also, dedicated circularity requirements tailored to biobased systems are still largely lacking, despite being ...
Iris Vural Gursel, Heleen Ballemans, Heike Axmann, Lesly Garcia‐Chavez, Marta Rodriguez‐Illera, Laura Väyrynen   +5 more
wiley   +1 more source

Recognition and International Legal Personality of Non-State Actors [PDF]

, 2016
There is no doubt that states and international organizations are regarded as subjects of international law. The position of other entities acting in international relations is unclear.
Czapliński, Władysław
core  

THE USE OF SHARED COMPETENCES IN THE EUROPEAN UNION’S EXTERNAL RELATIONS THROUGH MIXED AGREEMENTS

Iustinianus Primus Law Review, 2017
Throughout its treaty making powers, the EU tends to emphasize its international personality and identity. However, when it comes to the international relations, the Member States still have legitimate interests.
Julija Brsakoska Bazerkoska
doaj  

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

Precision medicine in paediatrics: Progress and priorities

British Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain, Claire Booth, Joseph F. Standing, Charlotte I. S. Barker   +3 more
wiley   +1 more source

Problems of International Legal Personality of Individuals

, 2019
The author touches upon the issue of the international legal personality of individuals, and also considers scientific research on this issue. A large number of fundamental scientific works were taken into account, which later made it possible to reveal the ambiguity of the scientists' positions.
openaire   +2 more sources

Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild‐to‐moderate asthma

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin and is approved for adolescents and adults with severe asthma. This analysis assessed pharmacokinetics (PK), pharmacodynamics and safety of tezepelumab up to 85 days postdose in adolescents and children.
Anna Lundahl, Jonathan Grigg, Lubna Abuqayyas, Piotr Kuna, Gillian Hunter, Beata Pawlikowska, Jacob Leander, Michael Levin, Atul Gupta, James Paton, Katharine C. Pike, Jane R. Parnes, Gun Almqvist, Stephanie L. Roseti, on behalf of the study investigators   +14 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

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

Personality Disorder Diagnoses in Outpatient Forensic Mental Health: A Comprehensive Prevalence Study in the Netherlands. [PDF]

Personal Ment Health
Van Reijswoud BE, Doubkova N, Rossi G, van Dam A, Markus W, Uzieblo K.   +5 more
europepmc   +1 more source