Ispe Technology Transfer

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance.

Access to science and technology worldwide is achieved by active participation in open international scientific research, as well as through technological capability that is decisive in catching up with world developments in science and technology. In other words, it is the "national system of innovation" which determines a country's assimilation capacity. The universities, research institutions, the technological infrastructure, industrial training schemes, information networks and technical institutions in general provide the foundation for a solid, steady development. Therefore policies directed toward strengthening the national system of innovation are essential for a catching-up strategy. But even more important is the presence of skilled and experienced people with the necessary connections to the scientific and technological infrastructure of the world at large. this applies to China in particular. Whether or not the technological potential will be developed, depends on the technological and industrial strategies promoted by the Chinese leadership. In addition, the costs and benefits of technological development are affected by the prevalent evolutionary stage of a country's political framework and fiscal regime. There must be a strong coordination between overall economic policies and technology policy. A sucessful management of technology is only possible through a "technological package" including management, financial and marketing skills.

Access to science and technology worldwide is achieved by active participation in open international scientific research, as well as through technological capability that is decisive in catching up with world developments in science and technology. In other words, it is the "national system of innovation" which determines a country's assimilation capacity. The universities, research institutions, the technological infrastructure, industrial training schemes, information networks and technical institutions in general provide the foundation for a solid, steady development. Therefore policies directed toward strengthening the national system of innovation are essential for a catching-up strategy. But even more important is the presence of skilled and experienced people with the necessary connections to the scientific and technological infrastructure of the world at large. this applies to China in particular. Whether or not the technological potential will be developed, depends on the technological and industrial strategies promoted by the Chinese leadership. In addition, the costs and benefits of technological development are affected by the prevalent evolutionary stage of a country's political framework and fiscal regime. There must be a strong coordination between overall economic policies and technology policy. A sucessful management of technology is only possible through a "technological package" including management, financial and marketing skills.

Access to science and technology worldwide is achieved by active participation in open international scientific research, as well as through technological capability that is decisive in catching up with world developments in science and technology. In other words, it is the "national system of innovation" which determines a country's assimilation capacity. The universities, research institutions, the technological infrastructure, industrial training schemes, information networks and technical institutions in general provide the foundation for a solid, steady development. Therefore policies directed toward strengthening the national system of innovation are essential for a catching-up strategy. But even more important is the presence of skilled and experienced people with the necessary connections to the scientific and technological infrastructure of the world at large. this applies to China in particular. Whether or not the technological potential will be developed, depends on the technological and industrial strategies promoted by the Chinese leadership. In addition, the costs and benefits of technological development are affected by the prevalent evolutionary stage of a country's political framework and fiscal regime. There must be a strong coordination between overall economic policies and technology policy. A sucessful management of technology is only possible through a "technological package" including management, financial and marketing skills.