Rare Diseases Drug Development
Wei Zhang, Fangrong Yan, Feng Chen, Shein-Chung Chow in Advanced Statistics in Regulatory Critical Clinical Initiatives, 2022
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.
Issues in workplace mental health law
Takenori Mishiba in Workplace Mental Health Law, 2020
Mental health1 is an international issue.2 In 2001, the World Health Organization (WHO) attempted to define mental health (WHO, 2007),3 but there is currently no precise legal definition of mental health. Mental health is such a broad issue with multiple aspects and multiple layers that one could essentially relabel “mental health” as mental, physical, and social well-being and the manner in which individuals or organizations exist.4 Changes in the circumstances of a person’s life are typically cited when discussing the mounting evidence of mental health issues or the increased prevalence of those issues.5 In light of these trends, there are several mental health topics that can be addressed in the workplace to some extent. Specific examples are: 1) employee suicide, 2) loss due to employees not regularly showing up for work or failing to show up for work entirely (absenteeism),6 3) loss due to decreased productivity among full-time employees (presenteeism7), 4) the ease with which individuals with mental health issues can be refused employment or terminated8 as well as the burden on other workers when an individual continues to work, even if he/she should be suspended from his/her job, 5) diminishing organizational commitment,9 and 6) a dearth of (or a decline in) verbal and non-verbal communication in the workplace10 either as a cause or as a result of problems 1) through 5). All of these problems can affect human resources, personnel management, and an organization’s management structure and can lead directly or indirectly to legal issues.
The recovery approach and risk management
Chambers Mary in Psychiatric and mental health nursing, 2017
Organizational commitment. A number of documents outlined mental health professionals’ role in encouraging service users’ and their families’ involvement in service development and evaluation in order to improve the quality of service provision.13,14 One practice-based document reported by the National Institute of Mental Health in England15 states that it is an essential requirement for mental health professionals to be committed to work outside their usual working hours in order to ensure service users are able to move in and out of the system as required and therefore enable them to direct their own recovery process.
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
Human resources play a significant role in the development and evolution of healthcare and treatment issues and are considered as the key foundation of each organization and have always been emphasized by human resources management experts [7, 8]. One of the important organizational issues is commitment and competent managers endeavor to increase this factor among their employees because they consider it necessary for the development and improvement of the organization [9, 10]. Organizational commitment is considered to be an efficient achievement obtained by the organizations’ goals and values and also helps organizations achieve the role of the individuals in relation to goals and values regardless of its entirely instrumental values [11]. Organizational commitment introduced as a structural phenomenon that results from organizational and investment changes and exchanges over time [12, 13]. In this regard, several researchers found that, in order to increase the efficiency of the organization, employees should have a high degree of occupational commitment, attachment, and satisfaction [14, 15]. Therefore, the existence of organizational commitment among employees is of higher importance especially in companies providing services such as hospitals and pre-hospital emergency care centers, because the efficacy and efficiency of such organizations are closely related to how services are provided by employees [16]. One of the important factors influencing the organizational commitment is the quality of working life that has recently been addressed by many managers who seek to improve their human resources [17].
How Does Organizational Commitment Relate to Job Performance? A Conservation of Resource Perspective
Published in Human Performance, 2020
Lincoln Jisuvei Sungu, Qingxiong (Derek) Weng, Enhua Hu, Johari Abdu Kitule, Qinyi Fang
The concept of organizational commitment has attracted extensive research (e.g., Meyer, Becker, & Vandenberghe, 2004; Meyer, Stanley, Herscovich, & Topolnytsky, 2002), owing to the link with numerous desired outcomes as high job performance (e.g., Van Scotter, 2000), low turnover (e.g., Payne & Huffman, 2005), and high job satisfaction (e.g., Yousef, 2000). Meyer and Allen (1991) differentiate between affective (AC), normative (NC), and continuance (CC) organizational commitment, with numerous studies supporting the distinctions (e.g., Dunham, Grube, & Castañeda, 1994). The belief of the Three-Component Model (Meyer & Allen, 1991, 1997) is that they have a negative relationship with turnover, but with other organizational outcomes like performance, the relations of AC and NC are positive though stronger for AC, while for a CC, either negative or no relationship.
The relationship between internal marketing and the organizational commitment of doctors and nurses at Mardi Waluyo Hospital, Metro Lampung Indonesia
Published in International Journal of Healthcare Management, 2018
John Suprihanto, Tunjung Dhamalia Wrangkani, Andreasta Meliala
In path analysis it is known that there are factors other than vision, reward, and development that are also parts of internal marketing and which affect the organizational commitment. Based on the results of previous studies, those other factors that affect the organizational commitment include demographic characteristics;2,17,23 and dispositional variables, i.e. factors relating to a persons’ nature;2 empowerment;32 learning opportunities, retirement plans, concerns for their patients, culture, job security, the person's relationship with their colleagues;33 job satisfaction;27 career opportunities and the organization's policies;34 and motivation.16 (Figure 1)
Related Knowledge Centers
- Industrial & Organizational Psychology
- Psychology
- Person–Environment Fit