Modelling individual differences in reading using an optimised MikeNet simulator: the impact of reading instruction.

Reading is vital for acquiring knowledge and studies have demonstrated that phonology-focused interventions generally yield greater improvements than meaning-focused interventions in English among children with reading disabilities. However, the effectiveness of reading instruction can vary among individuals. Among the various factors that impact reading skills like reading exposure and oral language skills, reading instruction is critical in facilitating children's development into skilled readers; it can significantly influence reading strategies, and contribute to individual differences in reading. To investigate this assumption, we developed a computational model of reading with an optimised MikeNet simulator. In keeping with educational practices, the model underwent training with three different instructional methods: phonology-focused training, meaning-focused training, and phonology-meaning balanced training. We used semantic reliance (SR), a measure of the relative reliance on print-to-sound and print-to-meaning mappings under the different training conditions in the model, as an indicator of individual differences in reading. The simulation results demonstrated a direct link between SR levels and the type of reading instruction. Additionally, the SR scores were able to predict model performance in reading-aloud tasks: higher SR scores were correlated with increased phonological errors and reduced phonological activation. These findings are consistent with data from both behavioral and neuroimaging studies and offer insights into the impact of instructional methods on reading behaviors, while revealing individual differences in reading and the importance of integrating OP and OS instruction approaches for beginning readers.

Be strong, be confident: the rise of China and the 2022 Beijing Winter Games.

Drawing on promotional materials in 2007-2008 and in 2021-2022, this article examines both Olympics to explore how the state has evolved in its governmental rationalities, and the related cultural and political implications. The 2022 Winter Games, despite its comparatively low profile and challenges posed by Covid-19, provided the Chinese state with a key moment to advance its confidence doctrine. Three discourses were mobilised pertaining to, first, the CCP's superb leadership and problem-solving skills; second, China's mega-infrastructure; and, third, created + made in China. The 2022 Olympics thus mobilised three confidence-driven discourses: leadership confidence, techno-scientific confidence, and creative confidence. In doing so, the 2022 Olympics envisioned, narrated, and materialised the popular discursive signifiers - technology, green and sustainability, and the future - the authorities already actively promoted in its political initiatives and policies. This contributed to the inward-oriented beliefs of self-reliance and self-improvement. Where we witnessed in 2008 a sense of curiosity and openness, within China and the world at large, we now face the complexities, dangers, and cultural essentialism, if not narcissism, of a confident China.

Exploring the Association Between Help-Seeking Intentions and Suicidal Ideation in Australian Adult Men.

Background: Men account for three-quarters of suicide deaths in Australia. Self-reliant masculine norms may act as barriers to men's help-seeking and contribute to suicidal ideation. Men who seek help may be less likely to experience suicidal ideation. Aim: We evaluated the association between help-seeking intentions and suicidal ideation in Australian adult men using data from Wave 2 of the Australian Longitudinal Study on Male Health (Ten to Men). Method: Using scores on the General Help-Seeking Questionnaire, we explored the association between informal help-seeking intentions (e.g., friend, family), formal help-seeking intentions (e.g., psychologist), overall help-seeking intentions (all sources), and new-onset suicidal ideation. We conducted logistic regression analyses using a sample of 7,828 men aged 18-60 years. Results: Increased overall help-seeking intentions and informal help-seeking intentions were significantly associated with lower odds of new-onset suicidal ideation, whereas formal help-seeking intentions were not significantly associated. Limitations: The cross-sectional design limits inferences about causality. Conclusion: Men who have greater informal help-seeking intentions may be less likely to experience a new onset of suicidal ideation; however, more longitudinal research is needed.

Safety assessment of the process Reliance Industries, based on the ProTec technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Reliance Industries (EU register number RECYC315), which uses the ProTec technology. The input material consists of washed and dried poly(ethylene terephthalate) (PET) flakes, mainly originating from collected post-consumer PET containers, e.g. bottles, with no more than 5% PET from non-food consumer applications. The flakes are extruded into pellets (step 1), crystallised (step 2) and treated in a solid-state polycondensation (SSP) reactor (step 3). Having examined the challenge test provided, the Panel concluded that the extrusion and the decontamination in the ■■■■■ SSP reactor (steps 1 and 3) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 µg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature or below, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

Sensorimotor Dysfunction Following Anterior Cruciate Ligament Reconstruction- an Afferent Perspective: A Scoping Review.

Background: Sensorimotor dysfunction is thought to occur following anterior cruciate ligament (ACL) injury which may have implications on future reinjury risk. Dysfunction has been demonstrated within the efferent component of the sensorimotor system. However, no reviews have examined the two main components of the afferent system: the visual and somatosensory systems. Hypothesis/Purpose: This study aimed to report differences in function (central processing and local processing) within the (1) somatosensory and (2) visual systems between individuals following anterior cruciate ligament reconstruction (ACLR) and healthy controls (between-subject). The study also aimed to report differences in function within the two systems between the two limbs of an individual following ACLR (within-subject). Study Design: Scoping review. Methods: A search was conducted in PubMed, SPORTDiscus, CINAHL, Medline and Embase up until September 2021. Level I-IV studies assessing somatosensory and visual systems were included if they compared ACLR limbs to the uninjured contralateral limb (within-subject) or a healthy control limb (between-group). The function of somatosensory and visual systems was assessed across both central processing (processing of information in the central cortex) and local processing (all other assessments outside of central processing of information). Results: Seventy studies were identified (52 somatosensory, 18 visual). Studies examining somatosensory central processing demonstrated significant differences; 66% of studies exhibited within-subject differences and 100% of the studies exhibited between-group differences. Studies examining local somatosensory processing had mixed findings; 40% of the 'joint position sense (JPS)' and 'threshold to detect motion (TTDM)' studies showed significant within-subject differences (JPS=0.8°-3.8° and TTDPM=0.2°-1.4°) and 42% demonstrated significant between-group differences (JPS=0.4°-5° and TTDPM=0.3°-2.8°). Eighty-three percent of visual central processing studies demonstrated significant dysfunction between-groups with no studies assessing within-subject differences. Fifty percent of the studies examining local visual processing demonstrated a significant between-group difference. Conclusion: Significant differences in central processing exist within somatosensory and visual systems following ACLR. There is mixed evidence regarding local somatosensory and visual processing. Increased compensation by the visual system and local visual processing dysfunction may occur in conjunction with somatosensory dysfunction.

Impact Assessment of Divergence on Post-approval Changes Classifications of Latin America Region With Europe and the United States, and Propositions to Harmonize Classification Based on Risk as a Path to Build the Trust Between National Regulatory Agencies.

The lack of harmonization in the post-approval changes (PACs) classifications for pharmaceutical products may have an impact on the efficient implementation of PACs and in the supply of medicine, jeopardizing the continuity of therapies, especially in the case of chronic diseases. The percentage of similarity between the PACs classifications existing between countries of Latin America (Mexico, Brazil, Colombia, Venezuela, Argentina, Chile, Ecuador, Peru, and Central America) versus Europe and the United States (US) has been calculated, focused on the PACs for chemical products and on the minor and moderate variations as defined in the European Union (EU)1,2 and US3 regulations. Even though Mexico, Colombia, Brazil, and Argentina implemented a risk-based PACs classification, a wide diversity is observed, with a high percentage of variations classified as major or high risk for these countries and the rest of the Latin American countries, except for Venezuela (which previously adopted and recognized the EU classification). In addition, we identified a group/subset of PACs that are not categorized in the regulations of Mexico, Brazil, Chile, and Central America countries. Considering that Mexico, Brazil, and Argentina are members or observers of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use4 and the Pharmaceutical Inspection Co-operation Scheme,5 these countries could further align their PACs classification with the EU and US regulations. This could also be an opportunity for other countries of the Latin America region to recognize and adopt PACs classifications aligned to the EU or United States, which would also support the inclusion of reliance processes in their regulation for already considered/recognized reference countries. This would guarantee more health authority efficiency and optimization as well as more uniform implementation of PACs globally.

Broadening the Perspective on the Dynamics of Men's Suicide: Thought Suppression as a Mediator between Men's Self-Reliance and Suicidality.

OBJECTIVE: In most countries, men are at higher risk than women for suicide death. Research focused on masculinity and men's mental health increasingly demonstrates that relationships between gender and various health outcomes, including suicidality, is complex as these relationships can be further explained by certain psychological processes or health behaviors. The objective of this study was to extend this area of research in a national sample of US men (n = 785) by investigating if their adherence to certain hegemonic masculine gender role norms (toughness and self-reliance through mechanical skills) is associated with the suppression of distressing thoughts and if thought suppression then increases their risk for suicidal thoughts and behaviors. METHODS: Men in the US who have recently experienced a stressful life event completed an anonymous online survey. Structural Equational Modeling (SEM) was used to test for direct and indirect effects (i.e., mediation) between variables. RESULTS: Men's engagement in thought suppression mediated the relationship between self-reliance and suicidality. The norm of toughness was both directly related to suicidality and mediated by thought suppression. CONCLUSIONS: Thought suppression appears to be a process that provides some explanation for the relationships between hegemonic masculine norms and suicidality in men, though this study indicated it may play only a small role. Research continues to build that certain masculine norms, such as self-reliance and toughness, are particularly concerning for men's health.HIGHLIGHTSMen's thought suppression mediates the relationship between self-reliance and suicidalityMen's toughness impacts suicidality both directly and via engagement in thought suppressionThese findings have implications for interventions that help men manage distressing thoughts.

Does monitoring pests pay off? a bioeconomic assessment of Drosophila suzukii controls.

BACKGROUND: Drosophila suzukii is a significant invasive pest that has caused high management costs and economic losses for blueberry growers in the United States. The status quo control strategy commonly used by growers is to apply pesticides proactively and frequently to reduce infestation. Recent studies have shown that the calendar-based spraying strategy might be unsustainable in the long term, making the reduction of pesticide reliance a top priority for the berry industry. Incorporating pest monitoring into the control strategy could be an option to improve efficiency while reducing pesticide usage. This study assesses the economic implications of monitoring-based control strategies compared to calendar-based spraying control strategies for organic blueberry production in Oregon. We combine a D. suzukii population model into the economic simulation framework, evaluate two monitoring methods (adult trapping and fruit sampling), and identify the profit-maximizing control strategy under different scenarios. RESULTS: In the baseline scenario, control strategies that incorporate fruit sampling exhibit the highest average profits. Although the status quo control strategy (spraying every 3 days) generates higher average revenue than monitoring-based strategies, the cost from the higher number of pesticide application offsets the returns. CONCLUSION: This study uses a novel bioeconomic simulation framework to show that incorporating fruit sampling can be a promising tool to reduce pesticide reliance while controlling D. suzukii infestation. These findings provide clearer information on the economic viability of using monitoring-based pest control strategies in organic berry production, and the assessment framework sheds light on the economics of pest management. © 2023 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

The effects of kinesiophobia on postural control with chronic ankle instability.

BACKGROUND: Patients with chronic ankle instability (CAI) often experience injury-related fear following ankle injuries, a condition known as kinesiophobia. Little research has investigated the impact of kinesiophobia in patients with CAI. RESEARCH QUESTION: How does kinesiophobia impact the static and dynamic balance of individuals with CAI? METHODS: Fifty patients with CAI were divided into 2 subgroups based on their responses to the Tampa Scale of Kinesiophobia: 25 with kinesiophobia (CAI-K) and 25 without kinesiophobia (CAI-N). These groups were compared to 20 control participants. All participants performed a single-leg balance test with eyes open (EO) and eyes closed (EC). They also performed the Y-balance test (YBT) with EO. Romberg ratios were calculated as EC/EO and used for statistical analysis. RESULTS: No differences in static balance with EO and EC were found among three groups. However, the CAI-K group displayed a higher Romberg ratio in the mediolateral direction during static balance than both CAI-N and control groups. Additionally, both CAI-K and CAI-N groups displayed higher Romberg ratio in the anterior-posterior than controls. During YBT, the CAI-K group showed reduced reach distance in the anterior direction than CAI-N and control groups. SIGNIFICANCE: The CAI-K group relies more on visual feedback during static balance in the mediolateral direction than CAI-N and control groups. Furthermore, the CAI-K group displayed less anterior reach distance during YBT compared to the CAI-N and control groups. Clinicians should consider both psychological and physical factors when designing rehabilitation programs.

Worldwide Regulatory Reliance: Launching A Pilot on A Chemistry, Manufacturing and Control Post Approval Change for A Vaccine.

When an initial marketing authorization of a pharmaceutical product is granted, a substantial number of chemistry, manufacturing and control (CMC) post approval changes (PACs) have to be managed by the manufacturers. Despite efforts undertaken over the years by multiple regulatory jurisdictions, there is still heterogeneity in terms of regulatory requirements and timelines across national regulatory authorities (NRAs). This creates complexity in managing global CMC PACs, putting the supply of medical products at risk. Regulators have developed regulatory mechanisms which aim at accelerating the reviews and approvals of PACs by NRAs. The World Health Organization (WHO) is supporting the concept of 'reliance' amongst NRAs which are encouraged to rely on the assessment completed by a ″high-performing authority″. The objective is to accelerate the overall process for PACs, ultimately fostering more equitable and timely access of medical products to populations who need them. With the support of Health Canada, WHO, Pan American Health Organization, and the Paul-Ehrlich-Institut, Sanofi has launched a pilot using the principles of reliance for a CMC PAC for a vaccine, with 21 NRAs who accepted to participate in the pilot. The objective of this pilot was to apply these principles to reduce the approval timeline to a maximum of 6 months, in all countries after an initial approval is granted by a reference authority. We discussed the opportunities and challenges of implementing reliance principles for CMC PACs. We also described the pilot experience, by sharing initial lessons learned from the Step 1 of this pilot, which consist of engaging the reference authority and the NRAs.

Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities.

Introduction: The World Health Organization (WHO) advocates the use of reliance practices to enable national regulatory authorities (NRAs) to improve patients' access to medicines. This study considered whether reliance review translates into swifter medicine authorization. Methods: Abridged review outcomes were examined for New Chemical Entity (NCE) and generic applications to the South African Health Products Regulatory Authority (SAHPRA) in Chemistry, Manufacturing and Controls (CMC) and clinical/bioequivalence (BE), as well as overall NCE authorization times. Results: SAHPRA NCE CMC review time was 91 days (abridged) vs. 179 days (full), applicant response time was 34 vs. 105 days, respectively, and there was a >2-fold time reduction for abridged vs. full CMC review (125 vs. 284 days). There was a 99-day decrease in clinical approval time through an abridged review (230 vs. 329 days) and a decrease in marketing authorization time for NCE abridged assessment (446 vs. 619 days). SAHPRA review time for generic applications was 97 days (abridged) vs. 191 days (full); applicant response time was 26 days (abridged) vs. 81 days (full) and there was a >2-fold time reduction for CMC and BE abridged vs. full review (122 vs. 272 days). Conclusion: These results clearly support World Health Organization recommendations for the use of reliance-based regulatory review to expedite the worldwide availability of safe, effective and needed medications.

Visual Disruption Influences Neuromechanics during Landing Cutting in Individuals with Chronic Ankle Instability.

CONTEXT: Individuals with chronic ankle instability (CAI) appear to demonstrate altered movement patterns when their vision is disturbed during simple tasks such as single-leg standing and walking. However, it remains unclear whether visual disruption by stroboscopic glasses alters movement patterns during landing cutting movements, considered highly demanding sports maneuvers that mimic a typical athletic movement. OBJECTIVE: This study aimed to identify altered lower extremity kinematics and muscle activation when participants' vision was disrupted by stroboscopic glasses during landing cutting tasks in CAI patients. DESIGN: A case control design. SETTING: A controlled laboratory setting. PATIENTS OR OTHER PARTICIPANTS: Eighteen CAI patients and 18 matched healthy controls volunteered to participate in the study. All participants performed 5 trials of landing cutting with (SV) and without (NSV) stroboscopic glasses. MAIN OUTCOME MEASURES: Frontal and sagittal lower extremity kinematics, and 6 lower extremity muscle activations during the stance phase of landing cutting tasks with (SV) and without stroboscopic glasses (NSV). RESULTS: CAI patients demonstrated more inversion angle from 18% to 22% and from 60% to 100% of the stance phase and more peroneal longus activation from initial contact to 18% of the stance phase under the SV condition compared to the NSV condition. There were no differences in knee and hip joint angles between the visual conditions for both groups. CONCLUSIONS: When wearing stroboscopic glasses, CAI patients showed altered movement patterns, including increased inversion angle and peroneus longus activation during the stance phase of landing cutting. The results suggest that CAI patients may lack the ability to reweight sensory information to adapt their movement to visual disruption.

Regulatory agilities impacting review timelines for Pfizer/BioNTech's BNT162b2 mRNA COVID-19 vaccine: a retrospective study.

The appropriate use of regulatory agilities has the potential to accelerate regulatory review, utilize resources more efficiently and deliver medicines and vaccines more rapidly, all without compromising quality, safety and efficacy. This was clearly demonstrated during the COVID-19 pandemic where regulators and industry rapidly adapted to ensure continued supply of existing critical medicines and review and approve new innovative medicines. In this retrospective study, we analyze the impact of regulatory agilities on the review and approval of Pfizer/BioNTech's BNT162b2 mRNA COVID-19 Vaccine globally using regulatory approval data from 73 country/regional approvals. We report on the critical role of reliance and provide evidence that demonstrates reliance approaches and certain regulatory agilities reduced review times for the COVID-19 vaccine. These findings support the case for more widespread implementation of regulatory agilities and demonstrate the important role of such approaches to improve public health outcomes.

Psychometric properties of the Spanish SABA Reliance Questionnaire (SRQ) among patients with asthma.

Background: Patient beliefs about their asthma and its treatment may contribute to overreliance on short-acting ß2-agonist (SABA) therapy, leading to increased risk for potentially life-threatening exacerbations. The SABA Reliance Questionnaire (SRQ) is a validated tool for evaluating patients beliefs about SABAs that may lead to overreliance and overuse. Objective: Our aim was to evaluate the psychometric properties of the Spanish version of the SRQ. Methods: This was an observational, cross-sectional, single-country questionnaire validation study in adults with asthma. Reliability (ordinal α) and validity (convergent and discriminant) of SRQ were evaluated. Concurrent validity was assessed with the Beliefs about Medication Questionnaire, the Treatment Satisfaction Questionnaire for Medication, and a visual analog scale item to assess patients' perceptions of the importance of their reliever inhaler. Discriminant validity was assessed through differences in mean SRQ sum score between patients with high adherence to inhaled corticosteroids and those with low adherence, as measured by the Medication Adherence Report Scale-9 and the Test of Adherence to Inhalers. Results: The Spanish-SRQ exhibited good psychometric properties among 131 patients with asthma. Internal consistency was confirmed with an ordinal α of 0.85. All 5 items were useful for measuring patients' beliefs about SABAs that may lead them to be overreliant on SABAs. Concurrent validity with the Beliefs about Medication Questionnaire, Treatment Satisfaction Questionnaire for Medication, and a visual analog scale item assessing patients' perceptions of the importance of their reliever inhaler was demonstrated. Conclusion: The Spanish version of the SRQ is a valid tool for evaluating potential overreliance on SABAs in Spanish-speaking patients to enable early intervention and support.

An Evaluation of the Boys Do Cry Suicide Prevention Media Campaign on Twitter: Mixed Methods Approach.

BACKGROUND: In most countries, men are more likely to die by suicide than women. Adherence to dominant masculine norms, such as being self-reliant, is linked to suicide in men in Western cultures. We created a suicide prevention media campaign, "Boys Do Cry," designed to challenge the "self-reliance" norm and encourage help-seeking in men. A music video was at the core of the campaign, which was an adapted version of the "Boys Don't Cry" song from "The Cure." There is evidence that suicide prevention media campaigns can encourage help-seeking for mental health difficulties. OBJECTIVE: We aimed to explore the reach, engagement, and themes of discussion prompted by the Boys Do Cry campaign on Twitter. METHODS: We used Twitter analytics data to investigate the reach and engagement of the Boys Do Cry campaign, including analyzing the characteristics of tweets posted by the campaign's hosts. Throughout the campaign and immediately after, we also used Twitter data derived from the Twitter Application Programming Interface to analyze the tweeting patterns of users related to the campaign. In addition, we qualitatively analyzed the content of Boys Do Cry-related tweets during the campaign period. RESULTS: During the campaign, Twitter users saw the tweets posted by the hosts of the campaign a total of 140,650 times and engaged with its content a total of 4477 times. The 10 highest-performing tweets by the campaign hosts involved either a video or an image. Among the 10 highest-performing tweets, the first was one that included the campaign's core video; the second was a screenshot of the tweet posted by Robert Smith, the lead singer of The Cure, sharing the Boys Do Cry campaign's video and tagging the campaign's hosts. In addition, the pattern of Twitter activity for the campaign-related tweets was considerably higher during the campaign than in the immediate postcampaign period, with half of the activity occurring during the first week of the campaign when Robert Smith promoted the campaign. Some of the key topics of discussions prompted by the Boys Do Cry campaign on Twitter involved users supporting the campaign; referencing the original song, band, or lead singer; reiterating the campaign's messages; and having emotional responses to the campaign. CONCLUSIONS: This study demonstrates that a brief media campaign such as Boys Do Cry can achieve good reach and engagement and can prompt discussions on Twitter about masculinity and suicide. Such discussions may lead to greater awareness about the importance of seeking help and providing support to those with mental health difficulties. However, this study suggests that longer, more intensive campaigns may be needed in order to amplify and sustain these results.

Seeing does not mean processing: where we look and the visual information we rely on change independently as we learn a novel walking task.

People use vision to inform motor control strategies during walking. With practice performing a target stepping task, people shift their gaze farther ahead, transitioning from watching their feet contact the target to looking for future target locations. The shift in gaze focus suggests the role of vision in motor control changes from emphasizing feedback to feedforward control. The present study examines whether changing visual fixation location is accompanied by a similar change in reliance upon visual information. Twenty healthy young adults practiced stepping on moving targets projected on the surface of a treadmill. Periodically, participants' visual reliance was probed by hiding stepping targets which inform feedback or feedforward (targets < or > 1.5 steps ahead, respectively) motor control strategies. We calculated visual reliance as the increase in step error when targets were hidden. We hypothesized that with practice, participant reliance on feedback visual information would decrease and their reliance on feedforward visual information would increase. Contrary to our hypothesis, participants became significantly more reliant on feedback visual information with practice (p < 0.001) but their reliance on feedforward visual information did not change (p = 0.49). Participants' reliance on visual information increased despite looking significantly farther ahead with practice (p < 0.016). Together, these results suggest that participants fixated on feedback information less. However, changes in fixation pattern did not reduce their reliance upon feedback information as stepping performance still significantly decreased when feedback information was removed after training. These findings provide important context for how the role of vision in controlling walking changes with practice.

Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications.

INTRODUCTION: Promptly providing new drugs to fulfill unmet medical needs requires changes in drug development and registration processes. Health Authorities (HAs) considered as reference due to their experience and acknowledgement (Food and Drug Administration [FDA] among others) already consider innovative clinical trial (CT) designs and flexible approval procedures, but Latin America (LATAM) regulations are still far. A comparison was performed to identify gaps. MATERIALS AND METHODS: CT requirements for drug Marketing Authorization Application (MAA) and CT approval regulations were compared between LATAM and reference HAs (FDA/European Medicines Agency [EMA]/Health-Canada/Swissmedic/Therapeutic Goods Administration [TGA]/Pharmaceuticals and Medical Devices Agency [PMDA]), as of August 2022. Procedure included reference HAs regulations review, item selection, identification in LATAM regulations, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (ICH-E6[R2]/ICH-E8[R1]) implementation revision. RESULTS: For MAA, specific application requirements or ICH guideline M4(R4) on common technical document (CTD) adoption are generally stated, and phase-I/III performance is mandatory (explicitly/implicitly). Faster patient access procedures are infrequent: Priority-drug programs, conditional authorizations, or expedited procedures are scarce or non-existent. Regulatory reliance procedures are adopted through different pathways. Regarding CT approval, innovative/complex CT designs are not prohibited but usually omitted. Some countries implemented adapted CT conducting during the COVID-19 pandemic. Early scientific advice meetings (HA-sponsor) are occasionally considered. Most countries are not formally ICH-joined. CONCLUSIONS: LATAM regulations must adapt to new regulatory standards (FDA/EMA/ICH) through implementation of frequent updates, reliance/expedited procedures, early HA-sponsor interactions, innovative/complex CTs, mandatory phase-III reaching elimination, and decentralized elements for CT conducting.

What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements.

Regulatory harmonization and convergence have been identified as the key driver in promoting efficient evaluation of medicines, reducing workload, and supporting earlier access to medicines on the African continent. There has been great progress to date in enhancing regulatory harmonization and convergence on the African continent via the Regional Economic Communities (RECs) and with the establishment of the Africa Medicines Agency (AMA). In this article, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Africa Regulatory Network (ARN) presents its perspective based on the available literature review and results from a survey conducted with innovative biopharmaceutical companies to gather experiences using regional joint assessment procedures (JAPs) in Africa, such as the East African Community Medicines Regulatory Harmonization (EAC-MRH), the West African Medicines Regulatory Harmonization (WA-MRH), and the Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiative through the ZAZIBONA Collaborative Procedure for Medicines Registration (ZaZiBoNa), and provides best practices in this evolving landscape. The article also assesses other collaborative registration pathways available to facilitating registration of pharmaceutical products in African countries, such as WHO Collaborative Registration Procedures (CRP), Swissmedic's Marketing Authorisation for Global Health Products (MAGHP) and EU Medicines for All (EU-M4ALL). Benefits and challenges of each of the existing pathways are discussed in this article. Main benefits include building more expert capacity and improved collaboration amongst experts, as well as shorter review timelines in some cases. Key challenges include the lack of predictability in the adherence to procedural timelines as defined per guidelines, lengthy timeline to achieve national marketing authorization following joint assessment, the lack of dedicated personnel, administrative issues during the submission process as well as additional country-specific requirements on top of JAP-specific requirements. Our recommendations for improvements include harmonization of requirements across countries and regions and with international standards, appropriate resource allocation for JAP activities to ensure adherence to timelines, use of JAPs throughout the entire product lifecycle and all product categories, adequate use of digital technologies, and improved communication and transparency with applicants. These improvements will allow industry to better plan their filing strategies for the region which will lead to overall improved usability of the JAPs in Africa and enable faster patient access.

The Ability to Use Contextual Information in Object and Scene Recognition in Patients with Mild Cognitive Impairment.

BACKGROUND: The ability to understand and make use of object-scene relationships are critical for object and scene recognition. OBJECTIVE: The current study assessed whether patients with mild cognitive impairment (MCI), possibly in the preclinical phase of Alzheimer's disease, exhibited impairment in processing contextual information in scene and object recognition. METHODS: In Experiment 1, subjects viewed images of foreground objects in either semantic consistent or inconsistent scenes under no time pressure, and they verbally reported the names of foreground objects and backgrounds. Experiment 2 replicated Experiment 1, except that subjects were required to name scene first. Experiment 3 examined object and scene recognition accuracy baselines, recognition difficulty, familiarity with objects/scenes, and object-scene consistency judgements. RESULTS: There were contextual consistency effects on scene recognition for MCI and healthy subjects, regardless of response sequence. Scenes were recognized more accurately under the consistent condition than the inconsistent condition. Additionally, MCI patients were more susceptible to incongruent contextual information, possibly due to inhibitory deficits or over-dependence on semantic knowledge. However, no significant differences between MCI and healthy subjects were observed in consistency judgement, recognition accuracy, recognition difficulty and familiarity rating, suggesting no significant impairment in object and scene knowledge among MCI subjects. CONCLUSIONS: The study indicates that MCI patients retain relatively intact contextual processing ability but may exhibit inhibitory deficits or over-reliance on semantic knowledge.