Combined effect of compressing fresh concrete and curing regime on bonding performance of high strength repair mortar.

High strength concrete (HSC) is highly appropriate for the retrofitting and rehabilitation of reinforced concrete structures due to its low permeability and high bonding strength. However, its low workability and sensitivity to curing conditions pose significant challenges for its implementation in such projects. This study introduces a novel technique to overcome the workability barrier of HSC while enhancing its bonding strength under various curing conditions.

Utilization and integration of microalgae consortium in treating undiluted anaerobic digestate animal effluent to produce animal feed, bio-oil, and biogas.

Anaerobic digestate animal effluent (ADAE) contains high N and P nutrients which need to be treated. In this study, an integrated process was proposed using a microalgae consortium of Chlorella and Scenedesmus. The system was designed for 71 m/d (medium-sized) and 355 m/d (large-sized) animals of ADAE.

Studying the Impact of European Union Regulatory Interventions for Minimising Risks From Medicines: Lessons Learnt and Recommendations.

Purpose: The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) launched a strategy to examine the public health impact of major regulatory interventions aimed at minimising risks of medicinal products. We conducted a lessons learnt analysis of impact studies completed between 2015 and 2023.

Methods: We surveyed PRAC Sponsors and (Co-)Rapporteurs involved in the evaluation of 12 impact studies (10 commissioned by EMA and 2 conducted collaboratively by Member States) to explore how these support regulatory decision-making.

The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.

This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU). Its legislative aim of better patient and public health protection through new responsibilities for pharmaceutical companies and regulatory bodies is considered to have been achieved and is well supported by the good pharmacovigilance practices 'EU-GVP'. For future progress, we set out a vision for high-quality pharmacovigilance in a world of ongoing medical, technological and social changes.

Medicines for an aging population: The EMA perspective and policies.

The European Medicines Agency adopted their Geriatric Medicines Strategy more than a decade ago. The strategy aims at elucidating the evidence basis for marketing authorization of new medicines which will be used in the older population, and at ensuring the appropriate communication of findings to the patient and healthcare provider. During the past decade new tools and data sources have emerged to support the strategy goals, and their use should be considered.

Process design and economic analysis for the production of microalgae from anaerobic digestates in open raceway ponds.

A model based framework was established for large scale assessment of microalgae production using anaerobically digested effluent considering varied climatic parameters such as solar irradiance and air temperature. The aim of this research was to identify the optimum monthly average culture depth operation to minimize the cost of producing microalgae grown on anaerobic digestion effluents rich in ammoniacal nitrogen with concentration of 248 mg L. First, a productivity model combined with a thermal model was developed to simulate microalgae productivity in open raceway ponds as a function of climatic variables.

Microalgae cultivation for treating agricultural effluent and producing value-added products.

Wastewater generated within agricultural sectors such as dairies, piggeries, poultry farms, and cattle meat processing plants is expected to reach 600 million m yr globally. Currently, the wastewater produced by these industries are primarily treated by aerobic and anaerobic methods. However, the treated effluent maintains a significant concentration of nutrients, particularly nitrogen and phosphorus.

Nitrogen dynamics and biological processes in soil amended with microalgae grown in abattoir digestate to recover nutrients.

The use of microalgae for nutrient recovery from wastewater and subsequent conversion of the harvested biomass into fertilizers offers a sustainable approach towards creating a circular economy. Nonetheless, the process of drying the harvested microalgae represents an additional cost, and its impact on soil nutrient cycling compared to wet algal biomass is not thoroughly understood. To investigate this, a 56-day soil incubation experiment was conducted to compare the effects of wet and dried Scenedesmus sp.

Lactic acid production from food waste at an anaerobic digestion biorefinery: effect of digestate recirculation and sucrose supplementation.

Low lactic acid (LA) yields from direct food waste (FW) fermentation restrict this production pathway. However, nitrogen and other nutrients within FW digestate, in combination with sucrose supplementation, may enhance LA production and improve feasibility of fermentation. Therefore, this work aimed to improve LA fermentation from FWs by supplementing nitrogen (0-400 mgN·L) as NHCl or digestate and dosing sucrose (0-150 g·L) as a low-cost carbohydrate.

What Factors Make EU Regulators Want to Communicate Drug Safety Issues Related to SGLT2 Inhibitors? An Online Survey Study.

Introduction: Previous studies have found differences in the communication of safety issues among medicines regulatory agencies.

Objectives: To explore (1) to what extent regulators' opinions regarding the need to communicate safety issues related to sodium-glucose cotransporter-2 (SGLT2) inhibitors might be influenced by their concern about the safety issue, and (2) whether regulators' concerns might be influenced by certain characteristics of the safety issue or by the demographic and professional characteristics and attitudes of the regulators.

Methods: An online cross-sectional survey study with a rating-based conjoint analysis among clinical and pharmacovigilance assessors from the EU regulatory network was performed between April and June 2021.

Long term outdoor microalgal phycoremediation of anaerobically digested abattoir effluent.

Sufficient and reliable long-term field data on the growth, productivity and nutrient removal rates of microalgal based wastewater treatment system is essential to validate its overall techno-economic feasibility. Here, we investigated the semi-continuous microalgal cultivation of Scenedesmus sp. in anaerobically digested abattoir effluent (ADAE) for 13 months in outdoor raceway ponds operated at 20 cm depth.

How do safety warnings on medicines affect prescribing?

Introduction: Many adverse effects of medicines only become known after approval, prompting regulatory agencies to issue post-market safety advisories to support safer care. Our team evaluated advisories issued by national regulators in Australia, Canada, Denmark, the United Kingdom, and the United States from 2007 to 2016 inclusive, comparing regulators' decisions to warn, effects on prescribing, doctors' awareness and responses to warnings, relevant regulatory policies, and specific case studies.

Areas Covered: Based mainly on our research program and a narrative review, this commentary describes how often regulators issue safety advisories and effects on clinical practice.

Systematising Pharmacovigilance Engagement of Patients, Healthcare Professionals and Regulators: A Practical Decision Guide Derived from the International Risk Governance Framework for Engagement Events and Discourse.

Introduction: Input from patients and healthcare professionals to regulatory assessments is essential for benefit-risk management of medicines. How to best obtain input in different risk scenarios is uncertain.

Objectives: The objective of this study was to investigate whether the International Risk Governance Council (IRGC) Framework is applicable to pharmacovigilance and can guide selecting engagement mechanisms for optimising stakeholder input.

Monochromatic light filters to enhance biomass and carotenoid productivities of Dunaliella salina in raceway ponds.

Monochromatic blue and red wavelengths are more efficient for light to algal biomass conversion than full-spectrum sunlight. In this study, monochromatic light filters were used to down-regulate natural sunlight to blue (400-520 nm) and red (600-700 nm) wavelengths to enhance biomass productivity of Dunaliella salina in outdoor raceway ponds. Growth indices such as cell size, pigment concentrations, biomass yield, photosynthetic efficiency, and major nutritional compositions were determined and compared against a control receiving unfiltered sunlight.

The utility of real-world evidence for benefit-risk assessment, communication, and evaluation of pharmaceuticals: Case studies.

Purpose: In recent years, novel types of real-world evidence (RWE) have played a role in various decision-making processes relating to medicinal products, including regulatory approval, patient access, health technology assessment, safety monitoring, clinical use, and post-approval lifecycle management. We therefore reviewed the potential utility of RWE in the cycle of medicinal product benefit-risk (BR) assessment, communication/risk minimization and evaluation ("BRACE").

Methods: A convenience sample of illustrative studies was drawn from the published literature and examined.

Proposals for Engaging Patients and Healthcare Professionals in Risk Minimisation from an Analysis of Stakeholder Input to the EU Valproate Assessment Using the Novel Analysing Stakeholder Safety Engagement Tool (ASSET).

Introduction: Understanding the impact of regulatory actions for medicines and enablers/barriers for positive health outcomes is fundamental to effective risk minimisation measures (RMM). Therefore, the Impact Strategy of the European Union (EU) Pharmacovigilance Risk Assessment Committee (PRAC) includes engagement with patient communities and healthcare professional (HCP) bodies regarding RMM. However, there is uncertainty on how best to obtain stakeholder input.

Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States.

In the wake of the withdrawal of the nonsteroidal anti-inflammatory drug rofecoxib, regulators worldwide reconsidered their approach to postmarket safety. Many have since adopted a "life cycle" approach to regulation of medicines, facilitating faster approval of new medicines while planning for potential postmarket safety issues. A crucial aspect of postmarket safety is the effective and timely communication of emerging risk information using postmarket safety advisories, commonly issued as letters to healthcare professionals, drug safety bulletins, media alerts, and website announcements.

Why we need more collaboration in Europe to enhance post-marketing surveillance of vaccines.

The influenza A/H1N1 pandemic in 2009 taught us that the monitoring of vaccine benefits and risks in Europe had potential for improvement if different public and private stakeholders would collaborate better (public health institutes (PHIs), regulatory authorities, research institutes, vaccine manufacturers). The Innovative Medicines Initiative (IMI) subsequently issued a competitive call to establish a public-private partnership to build and test a novel system for monitoring vaccine benefits and risks in Europe. The ADVANCE project (Accelerated Development of Vaccine benefit-risk Collaboration in Europe) was created as a result.

Correction to: Patient Registries: An Underused Resource for Medicines Evaluation : Operational proposals for increasing the use of patient registries in regulatory assessments.

The fourth sentence under the heading "1.1 Use of Patient Registries for Supporting Regulatory Assessments" in "1 Introduction" section should read as below.