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Rare Diseases Drug Development
Published in Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow, Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
Shein-Chung Chow, Shutian Zhang, Wei Zhang
A drug that receives Breakthrough Therapy designation is eligible for the following: (i) all Fast Track designation features, (ii) intensive guidance on an efficient drug development program, beginning as early as phase 1, and (iii) organizational commitment involving senior managers. Similar to Fast Track designation, Breakthrough Therapy designation is requested by the drug sponsor. If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request provided that (i) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and (ii) the remaining drug development program can benefit from the designation. It should be noted that FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original Biologic License Application (BLA) or New Drug Application (NDA) or a supplement. FDA will respond to Breakthrough Therapy designation requests within 60 days of receipt of the request.
A Cross-Cultural Investigation into Three Measures of Work Orientation
Published in Walter J. Lonner, Dale L. Dinnel, Deborah K. Forgays, Susanna A. Hayes, Merging Past, Present, and Future in Cross-Cultural Psychology, 2020
Strong organizational commitment is seen as the strength of an employee’s identification with the organization. This manifests itself in terms of the employee’s strong belief in and acceptance of the goals set and values upheld by the organization, a willingness to walk the extra mile in the interest of the organization and a definite desire to remain a member of the organization.
Resilience and burnout
Published in Anna-leila Williams, Integrating Health Humanities, Social Science, and Clinical Care, 2018
Tragically, we have substantial evidence that shows physicians and nurses are significantly more likely to complete suicide than the general population (Alderson, Parent-Rocheleau, & Mishara, 2015; Center et al., 2003; Cheung & Yip, 2016). The striking statistics delimiting the excessive burden of physician and nurse suicide have been apparent for years, yet they remain a closeted secret. Until very recently, the healthcare system has largely ignored or subjugated the heartbreaking loss of life to suicide. We may be at a turning point, however. In 2016, the National Academy of Medicine widely broadcast depression and suicide data, and issued a call for organizational commitment statements to improve clinician well-being. Several august institutions representing physicians, nurses, pharmacists, dentists, health professions educators, academic medical centers, and more responded with action plans and initiatives. Although the link between burnout and suicide has yet to be made, some researchers have found an association between health professional burnout and hopelessness – which is considered a risk factor for suicide (Pomili et al., 2006).
Measuring Bullying in Sexual Minorities: Testing Two Bullying Scales in an LGB Sample
Published in Journal of Homosexuality, 2022
Nancy Day, Patricia Meglich, Tracy H. Porter
The expectation was that higher perceptions of bullying would result in lowered commitment. In terms of affective commitment, or the feeling of being emotionally attached to the organization, the NAQ-R (PR) predicted lower levels, as expected. However, the HBS did not significantly predict affective commitment. Continuance organizational commitment is defined as being tied to the organization because the cost of leaving is too high. However, counter to predictions, both the HBS and the NAQ-R (PR) are associated with higher continuance organizational commitment. Normative organizational commitment, or a feeling of obligation to stay with the organization (e.g., because of the investment the organization has made in training or other human-capital-building experience), was expected to be associated with lower perceptions of bullying. Although this was the case for the NAQ-R (PR), the HBS positively predicted normative organizational commitment in the opposite direction. Thus, hypothesis 3a is not supported.
Quality of working life and organizational commitment of Iranian pre-hospital paramedic employees during the 2019 novel coronavirus outbreak
Published in International Journal of Healthcare Management, 2022
Mohsen Aminizadeh, Amin Saberinia, Sahar Salahi, Mahdeyeh Sarhadi, Parya Jangipour Afshar, Hojjat Sheikhbardsiri
Organizational commitment can be defined simply as loyalties to the values and goals of the organization, sense of belonging, dependency, and moral obligation to stay in the organization [18, 19]. Organizational commitment is an important occupational and organizational attitude that has drawn researchers’ interests in organizational behavior courses in recent years because it is an important variable in understanding employee’s behavior [19, 20]. Staff who have a high level of organizational commitment are more friendly, happier, more efficient, loyal, and more accountable. They are hardworking employees and have lower cost [20, 21]. The study of Yousef defines commitment as a strength and power that obliges people to demonstrate rational behavior towards one or multiple objectives [22].
Factors that affect the perceived stress and organizational commitment of women nurse academicians in the COVID-19 pandemic: A descriptive cross-sectional study
Published in Health Care for Women International, 2023
As the Covid-19 pandemic has affected women more enormously than men in various areas, one of the most highly affected areas is the working status. Since improvements in working conditions of women duly depend on institution-specific policies (Sharma et al., 2020), the increased employee confidence in the organization simultaneously demonstrated more commitment for the organization (Gilboa et al., 2008). One of the most common models used for assessing an organization’s commitment is the “Organizational Commitment Model” (Dağlı et al., 2018). The Organizational Commitment Model consists of three components such as affective commitment, continuance commitment, and normative commitment that depicts the employee’s relationship with the organization. Affective commitment is an employee’s emotional attachment to their organization and identifying themselves with its progress. Individuals having high affective commitment can easily sustain in the organizational setup because they are highly motivated to perform effectively and are willing to make great efforts for the interests of the organization. Continuance commitment is the awareness of the costs associated with leaving the organization. Individuals with high continuation commitment show a strong desire to stay in the organization to avoid financial losses. Normative commitment is the commitment of employees feeling a sense of obligation to stay in an organization irrespective of their working capabilities. The sense of obligation to stay in the organization identifies with a set value system of an individual as well as the organization’s goals and values (Allen & Meyer, 1996; Dağlı et al., 2018).