The role of regulatory affairs in the drug development process must and has expanded to meet the goals of quicker and more efficient drug development. The regulatory affairs professional participating in the process of development will be to a greater degree placed in the proverbial “hot seat” to achieve expedited clinical development and rapid review. To achieve this goal, the regulatory affairs professional needs to be proactive and futuristic in his/her thinking, be able to monitor regulatory trends, possess scientific expertise in one or more therapeutic areas, maintain constructive relations with regulatory authorities, work effectively with project teams, and develop an international perspective on drug development issues. This manuscript will explore these increasingly important issues and illustrate their application to various case studies of drug development.

The Regulatory Affairs Professional in the “Hot Seat” in the Drug Development Process

In a fast developing world, the technology -which effects human life in various subjects such as production, planning and marketing- is an important factor to meet the highest level of requirements. This situation has drawn attention of the organizations; identifying and using the technologies to suit their own needs have yielded positive results. However, in order to benefit from the used technology at an optimum level, technology management activities must be performed effectively. Especially, quality-focused competition and technology being the most important component which determines quality clearly prooves that technology management concept is very important for the organizations today. At this point, organizations' scarcity of knowledge about technology management has been effective in both indicating the importance of the subject and preparation of the study. In this study, the meaning of technology management in organizations, its importance, technology management process and the problems encountered during this process are examined in detail. Certain determinations and propositions about the subject are made by focusing on the causes of such problems. It is seen that organizations to restructure the technology management strategies in the light of such propositions is important. (Abstract)

Technology Management Process and Encountered Problems in Organizations

Stratejik Yonetim literaturunde, ustun degerlerin olusturulmasi ve ustun performansin aciklanmasinda kullanilan iki temel yaklasim one cikmaktadir. Bunlar Endustriyel Temelli Gorus ve Kaynak Temelli Teoridir. Bu teorilerle ilgili literatur incelendiginde, isletme stratejilerinin ne olmasi gerektiginin yani sira, isletme stratejilerinin uygulanabilirliginde ve basarisinda, teknolojinin potansiyel bir guc oldugu isaret edilmektedir. Bu baglamda bu calismanin amaci; teknoloji belirleme, secme, edinme, kullanma, koruma ve sonlandirma sureclerinin, isletme stratejik yonetim calismalariyla entegre olarak surekli gelistirilmesinin, genel isletme performansi uzerinde (SRU) etkisi olup olmadigini tespit etmektir.

/pdf/isletmelerde-stratejik-teknoloji-yonetimi-ve-surdurulebilir-2wso23w1xd.pdf

İşletmelerde strateji̇k teknoloji̇ yöneti̇mi̇ ve sürdürülebi̇li̇r rekabet üstünlüğü i̇li̇şki̇si̇ni̇n beli̇rlenmesi̇ ve otomoti̇v yan sanayi̇ i̇şletmeleri̇ üzeri̇ne bi̇r araştirma

At low relative humidity (RH), an edible wheat gluten film presents very low oxygen and carbon dioxide permeabilities [1.24 and 7.4 amol/(Pa m s), respectively, at 25 °C]. For higher than 60% RH, O2 and CO2 permeabilities increase exponentially [to 1290 and 36 700 amol/(Pa m s), respectively, at 95% RH], presumably due to the plasticizing effect of water molecules. Pectin, chitosan, pullulan, and myofibrillar protein films are also very permeable to O2 and CO2 at high RH. The selectivity ratio (CO2/O2 permeability) of all films tested at high RH was very high (from 10 to 28) as compared to conventional synthetic films (4 to 6). Keywords: Edible film; gas permeability; relative humidity

Influence of Relative Humidity and Film Composition on Oxygen and Carbon Dioxide Permeabilities of Edible Films

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The Regulatory Affairs Professional in the “Hot Seat” in the Drug Development Process

Technology Management Process and Encountered Problems in Organizations

İşletmelerde strateji̇k teknoloji̇ yöneti̇mi̇ ve sürdürülebi̇li̇r rekabet üstünlüğü i̇li̇şki̇si̇ni̇n beli̇rlenmesi̇ ve otomoti̇v yan sanayi̇ i̇şletmeleri̇ üzeri̇ne bi̇r araştirma

Influence of Relative Humidity and Film Composition on Oxygen and Carbon Dioxide Permeabilities of Edible Films

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