Objective To explore the risk management of the changes of sponsors and/or production sites during drug clinical trials based on the theories of quality management,risk management,and change management.Methods The met...Objective To explore the risk management of the changes of sponsors and/or production sites during drug clinical trials based on the theories of quality management,risk management,and change management.Methods The method of failure modes and effect analysis(FMEA)was used to identify risks through literature research,expert consultation,comparative research,and comprehensive analysis.Besides,risk priority number(RPN)was used to evaluate the risks.Results and Conclusion A FMEA of the changes of sponsors and/or production sites in clinical trials was constructed and RPN values of every failure mode and causes were obtained.Based on the RPN values,the core risk control points for different combination modes of sponsors and/or production sites after their changes were identified.It is recommended that China should strengthen the construction of the sponsor responsibility system.In addition,the changes of sponsors and/or production sites during the clinical trial period should be allowed in an orderly manner under the premise of ensuring the quality of clinical trials and subject protection.展开更多
The concept of benefaction,as shaped in the pre-industrial society,has been altered and replaced by the modern term of sponsoring.The verbal transformation emerges from a deep cultural shift.Focusing on the dipole of ...The concept of benefaction,as shaped in the pre-industrial society,has been altered and replaced by the modern term of sponsoring.The verbal transformation emerges from a deep cultural shift.Focusing on the dipole of benefactionsponsoring,we examine the cultural transition from the traditional communities of long duration to the modern societies of consumption,taking the Greek mountainous regions as an example.We investigate the cultural shift that generates the metastasis from the communities of benefaction to the modern brandplaces that consume their own cultural heritage,mainly,at the altar of the tourism industry.Modern society has adopted the concept of sponsoring,for the grace of which,culture has to prove evidence of economic value,in order to survive.In the extremely competitive frame of the free-market economy,mountain regions appear vulnerable.The selling and buying of their culture are tempting and attractive under a constantly shrinking welfare-state and narrowing development opportunities.It depends on local and national society to rediscover and regenerate those social mechanisms able to create culture or let the modern consumption-oriented forces prevail.However,authentic principles of benefaction may form an alternative perspective for social reorganization.展开更多
Correct definition and management of sponsor- investigator relationship is of central importance for planing and executing clinical trials. During the last decade, there have been numerous modifications of guidelindes...Correct definition and management of sponsor- investigator relationship is of central importance for planing and executing clinical trials. During the last decade, there have been numerous modifications of guidelindes, international and national legislations and regulations. This implicated various alterations and shifts of essential responsibilities and tasks relating to the investigator, sponsor or sponsor-investigator what raised financial, clinical and ethical issues. First experiences with these new regulations and legislations are discussed together with international differences and their impacts on clinical trials. Regarding non-commercial trials and institutional sponsorship, there are still open organizational and legal questions after national implementation of the Europeam Clinical Trials Directive in 2004, although various approaches have been suggested in recent years in Europe. Current trends and controversies are discussed as well. A literature review was performed summarizing recent experiences with current legislations and risen controversies of these new legislations showing impact on future trends.展开更多
The scientific program will consist of symposia and poster sessions. Topics related to theoretical and applied research in the domain of toxicology and toxicological studies on chemicals of public concern will be welc...The scientific program will consist of symposia and poster sessions. Topics related to theoretical and applied research in the domain of toxicology and toxicological studies on chemicals of public concern will be welcome. The presenter’s name, address, and telephone and FAX numbers should be submitted along with the title of the presentation and whether it is oral or poster. Deadline: April 15, 1990. Papers should be submitted to:展开更多
In China, with the restructuring of health care system moving forward, private community health facilities have been playing a complementary but increasingly important role in providing public health and basic medical...In China, with the restructuring of health care system moving forward, private community health facilities have been playing a complementary but increasingly important role in providing public health and basic medical care services in urban areas. However, only limited evidence is available con-cerning the service functions of private community health facilities in China. The aim of this study was to explore the functions of private community health stations (PCHSs) to provide evidence-based rec-ommendations for policy-making and practice in the development of urban community health services systems. A total of 818 PCHSs and 4320 government-sponsored community health stations (GCHSs) located in 28 cities of China were investigated in 2008. The percentages of stations that provided health services and the annual workload per community health worker (CHW) were compared between the two types of institutions. The results showed that the percentages of PCHSs providing public health services were significantly higher than those of GCHSs (P<0.05); but no significant differences were found in the percentages of basic medical services providing between PCHSs and GCHSs (P>0.05). The annual workloads of all the public health services and basic medical services per CHW in PCHSs were lighter than those in GCHSs (P<0.05), except for resident health records establishment and health education materials distribution (P>0.05). At present, the GCHSs are still the mainstream in urban China, which will last for a long period in future. However, our findings showed that the annual workloads of CHWs in PCHSs were no heavier than those in GCHSs, and the PCHSs were willing to provide public health services. In view of current inadequacy of health resources in China, it is feasible to further develop PCHSs under the guidance of the government, given that PCHSs can perform the basic functions of community health services, which is useful for the formation of public-private partnerships (PPP) and the improvement of community health services.展开更多
Chinese Society of Rare Earths Director General: Prof. Bi Qun Tel: 86 10 62182748 Fax: 86 10 62173501 Treibacher Industrie AG President: Mr. Reinhard Iro Managing Director Responsible For RE Business: Mr. Alexander Bo...Chinese Society of Rare Earths Director General: Prof. Bi Qun Tel: 86 10 62182748 Fax: 86 10 62173501 Treibacher Industrie AG President: Mr. Reinhard Iro Managing Director Responsible For RE Business: Mr. Alexander Bouvier Tel:0043 4262 505 570 Fax:0043 4262展开更多
Chinese Society of Rare Earths Vicarious Director General： Mr. Gan Yong Tel： 86 10 62182748 Fax： 86 10 62173501 Treibacher Zndustrle AG CEO： Mr. Reinhard Iro COO： Mr. Alexander Bouvier Tel：0043 4262 505 570...Chinese Society of Rare Earths Vicarious Director General： Mr. Gan Yong Tel： 86 10 62182748 Fax： 86 10 62173501 Treibacher Zndustrle AG CEO： Mr. Reinhard Iro COO： Mr. Alexander Bouvier Tel：0043 4262 505 570 Fax：0043 4262 505 8570展开更多
Chinese Society of Rare Earths Director General: Prof. Bi Qun Tel: 86 10 62182748 Fax: 86 10 62173501 Treibacher Industrie AG President: Mr. Reinhard Iro Managing Director Responsible For RE Business: Mr. Alexander Bo...Chinese Society of Rare Earths Director General: Prof. Bi Qun Tel: 86 10 62182748 Fax: 86 10 62173501 Treibacher Industrie AG President: Mr. Reinhard Iro Managing Director Responsible For RE Business: Mr. Alexander Bouvier Tel:0043 4262 505 570 Fax:0043 4262 2898 AMR Technologies Inc. President: Peter V. Gundy Tel: 001 416 3678588 Fax: 001 416展开更多
Chinese Society of Rare EarthsDirector General: Prof. Bi QunTel: 86 10 62182748 Fax: 86 10 62173501Baotou Rare Earth HI-Tech Development ZoneDirector: Prof. Su WenqingTel: 86 472 5159784/5128065 Fax: 86 472 5156391 Ch...Chinese Society of Rare EarthsDirector General: Prof. Bi QunTel: 86 10 62182748 Fax: 86 10 62173501Baotou Rare Earth HI-Tech Development ZoneDirector: Prof. Su WenqingTel: 86 472 5159784/5128065 Fax: 86 472 5156391 China Rare Earth Holdings LimitedPresident: Jiang Quanlong Tel: 86 510 7456666 Fax: 86 510展开更多
文摘Objective To explore the risk management of the changes of sponsors and/or production sites during drug clinical trials based on the theories of quality management,risk management,and change management.Methods The method of failure modes and effect analysis(FMEA)was used to identify risks through literature research,expert consultation,comparative research,and comprehensive analysis.Besides,risk priority number(RPN)was used to evaluate the risks.Results and Conclusion A FMEA of the changes of sponsors and/or production sites in clinical trials was constructed and RPN values of every failure mode and causes were obtained.Based on the RPN values,the core risk control points for different combination modes of sponsors and/or production sites after their changes were identified.It is recommended that China should strengthen the construction of the sponsor responsibility system.In addition,the changes of sponsors and/or production sites during the clinical trial period should be allowed in an orderly manner under the premise of ensuring the quality of clinical trials and subject protection.
文摘The concept of benefaction,as shaped in the pre-industrial society,has been altered and replaced by the modern term of sponsoring.The verbal transformation emerges from a deep cultural shift.Focusing on the dipole of benefactionsponsoring,we examine the cultural transition from the traditional communities of long duration to the modern societies of consumption,taking the Greek mountainous regions as an example.We investigate the cultural shift that generates the metastasis from the communities of benefaction to the modern brandplaces that consume their own cultural heritage,mainly,at the altar of the tourism industry.Modern society has adopted the concept of sponsoring,for the grace of which,culture has to prove evidence of economic value,in order to survive.In the extremely competitive frame of the free-market economy,mountain regions appear vulnerable.The selling and buying of their culture are tempting and attractive under a constantly shrinking welfare-state and narrowing development opportunities.It depends on local and national society to rediscover and regenerate those social mechanisms able to create culture or let the modern consumption-oriented forces prevail.However,authentic principles of benefaction may form an alternative perspective for social reorganization.
文摘Correct definition and management of sponsor- investigator relationship is of central importance for planing and executing clinical trials. During the last decade, there have been numerous modifications of guidelindes, international and national legislations and regulations. This implicated various alterations and shifts of essential responsibilities and tasks relating to the investigator, sponsor or sponsor-investigator what raised financial, clinical and ethical issues. First experiences with these new regulations and legislations are discussed together with international differences and their impacts on clinical trials. Regarding non-commercial trials and institutional sponsorship, there are still open organizational and legal questions after national implementation of the Europeam Clinical Trials Directive in 2004, although various approaches have been suggested in recent years in Europe. Current trends and controversies are discussed as well. A literature review was performed summarizing recent experiences with current legislations and risen controversies of these new legislations showing impact on future trends.
文摘The scientific program will consist of symposia and poster sessions. Topics related to theoretical and applied research in the domain of toxicology and toxicological studies on chemicals of public concern will be welcome. The presenter’s name, address, and telephone and FAX numbers should be submitted along with the title of the presentation and whether it is oral or poster. Deadline: April 15, 1990. Papers should be submitted to:
基金supported by agrant from"The National Urban Community Health Service System Building Project"of the Ministry of Health of China(No.)
文摘In China, with the restructuring of health care system moving forward, private community health facilities have been playing a complementary but increasingly important role in providing public health and basic medical care services in urban areas. However, only limited evidence is available con-cerning the service functions of private community health facilities in China. The aim of this study was to explore the functions of private community health stations (PCHSs) to provide evidence-based rec-ommendations for policy-making and practice in the development of urban community health services systems. A total of 818 PCHSs and 4320 government-sponsored community health stations (GCHSs) located in 28 cities of China were investigated in 2008. The percentages of stations that provided health services and the annual workload per community health worker (CHW) were compared between the two types of institutions. The results showed that the percentages of PCHSs providing public health services were significantly higher than those of GCHSs (P<0.05); but no significant differences were found in the percentages of basic medical services providing between PCHSs and GCHSs (P>0.05). The annual workloads of all the public health services and basic medical services per CHW in PCHSs were lighter than those in GCHSs (P<0.05), except for resident health records establishment and health education materials distribution (P>0.05). At present, the GCHSs are still the mainstream in urban China, which will last for a long period in future. However, our findings showed that the annual workloads of CHWs in PCHSs were no heavier than those in GCHSs, and the PCHSs were willing to provide public health services. In view of current inadequacy of health resources in China, it is feasible to further develop PCHSs under the guidance of the government, given that PCHSs can perform the basic functions of community health services, which is useful for the formation of public-private partnerships (PPP) and the improvement of community health services.
文摘Chinese Society of Rare Earths Director General: Prof. Bi Qun Tel: 86 10 62182748 Fax: 86 10 62173501 Treibacher Industrie AG President: Mr. Reinhard Iro Managing Director Responsible For RE Business: Mr. Alexander Bouvier Tel:0043 4262 505 570 Fax:0043 4262
文摘Chinese Society of Rare Earths Vicarious Director General： Mr. Gan Yong Tel： 86 10 62182748 Fax： 86 10 62173501 Treibacher Zndustrle AG CEO： Mr. Reinhard Iro COO： Mr. Alexander Bouvier Tel：0043 4262 505 570 Fax：0043 4262 505 8570
文摘Chinese Society of Rare Earths Director General: Prof. Bi Qun Tel: 86 10 62182748 Fax: 86 10 62173501 Treibacher Industrie AG President: Mr. Reinhard Iro Managing Director Responsible For RE Business: Mr. Alexander Bouvier Tel:0043 4262 505 570 Fax:0043 4262 2898 AMR Technologies Inc. President: Peter V. Gundy Tel: 001 416 3678588 Fax: 001 416
