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This paper develops a theory of how the size of the domestic market shapes firm competencies. Our theory implies that large markets are beneficial even if factors such as economies of scale or learning effects are absent. We validate by an international comparison of the performance of firms that provide engineering services to the oil and petrochemical industry. We concluded that, relative to the United States, the competitiveness of European or Japanese industries is greater in activities whose underlying competencies are not product specific and can be utilized across a variety of products. The benefits of large markets are greatest for activities based on product-specific competencies. [ABSTRACT FROM AUTHOR]

Pharmacovigilance science has traditionally been a discipline focussed on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proactive consideration of risks and potential benefits of drugs in the pre- and peri-approval stages of drug development, leading to a maturing of drug safety risk management. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also permitted a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines, which drive enhanced pharmacovigilance and safety risk management earlier in drug development.In this paper, we review international guidelines on pharmacovigilance planning applicable to the pre-approval phases of medicines development and provide author opinion on these guidelines’ potential drug safety implications. We discuss the possible evolution of a pharmaceutical industry model to respond to these guidelines; a view on multidisciplinary safety management teams is provided to encourage refinement of safety-signal identification and risk assessment early in drug development and to communicate important safety concerns to internal research efforts, patients, investigators and regulators. We further describe these functions in the context of the complexities of vulnerable populations, including the example of medicines research for paediatric populations. We also discuss the special role of epidemiology in pre-approval drug development and the impact on epidemiological science of changes to the pharmacovigilance paradigm. [ABSTRACT FROM AUTHOR]

North–South competition quality Analyzing a new database that makes it possible to disaggregate trade flows across many countries according to unit values, we show that international specialization in terms of quality within industries and product categories plays an important role in the dynamics of North–South competition. The different specialization of countries at different levels of development within products and across varieties is mirrored in the recent shifts in world market shares, which are very different across quality segments: the South is not gaining market share in high-value portions of trade pattern. In this respect Europe's specialization pattern appears to be different from that of the US and Japan, and may allow it to better resist the competitive pressure of the South. — Lionel Fontagné, Guillaume Gaulier and Soledad Zignago [ABSTRACT FROM AUTHOR]

The Japanese approach to manufacturing has been well documented. Many European firms have successfully adopted and adapted a variety of Japanese manufacturing techniques. This paper describes how a pharmaceutical manufacturer responded to an increased requirement for manufacturing flexibility through the introduction of a key Japanese manufacturing technique, namely machine set-up time reduction. An unusual feature of the study is the use of action research. The strong emphasis on participation and collaboration inherent in action research, was felt to make it appropriate to tackling the company's capacity problem. Not only were set-up times substantially reduced, but action research demonstrated the value of all staff being involved in the problem-solving process. [ABSTRACT FROM AUTHOR]

The present study analyzes the impact of firms' technological strategies on their financial performance. Technology strategies are defined by making a distinction between explorative and exploitative as well as collaborative and solitary technological activities. Several hypotheses are tested on a panel data set (1996-2003) of 168 research and development (R&D)-intensive firms based in Japan, the United States, and Europe and situated in five different industries (i.e., chemicals, pharmaceuticals, information and communication technologies [ICT], electronics, and nonelectrical machinery). This study's analyses confirm the existence of an inverted U-shape relationship between the share of explorative technological activities and financial performance. In addition, firms engaging more intensively in collaboration perform relatively stronger in explorative activities. At the same time, a negative relationship is observed between the share of collaborative technological activities and a firm's market value. This negative relationship is most pronounced in collaborative activities of an exploratory nature. Overall, these findings suggest that the value appropriation complexities of collaborative technological activities may offset their value-enhancing potential. [ABSTRACT FROM AUTHOR]