Risk management plan and pharmacovigilance system - biopharmaceuticals: biosimilars.

Editor literario del libro, Giancarlo Nota - All chapters are Open Access articles distributed under the Creative Commons Non Commercial-Share Alike-Attribution 3.0 license, which permits to copy, distribute, transmit, and adapt the work in any medium, so long as the original work is properly cited.

Flood risk management: What are the main drivers of prevention?

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Participatory action research on climate risk management, Bangladesh

The rural populations of southern Bangladesh are some of the most vulnerable communities in the world to the future impacts of climate change. They are particularly at risk from floods, waterlogged soils, and increasing salinity of both land and water. The objective of this project was to analyze the vulnerability of people in four villages that are experiencing different levels of soil salinity. The study evaluated the strengths and weaknesses of current coping strategies and assessed the potential of an index-based insurance scheme, designed diversification and better information products to improve adaptive capacity.

Regulation: A Burden in Biopharmaceutical Industry? The Case of EU-Risk Management Plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market.

Regulation: A burden in biopharmaceutical industry? The case of EU-risk management plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market. © 2010 IEEE.

Getting to zero: evidence-based healthcare risk management is key.

In this article we call for a new approach to patient safety improvement, one based on the emerging field of evidence-based healthcare risk management (EBHRM). We explore EBHRM in the broader context of the evidence-based healthcare movement, assess the benefits and challenges that might arise in adopting an evidence-based approach, and make recommendations for meeting those challenges and realizing the benefits of a more scientific approach.

Total Information Risk Management

This book provides you with all fundamental concepts, guidelines and tools to ensure core business information is identified, protected and used effectively, written in a language that is clear and easy to understand for non-technical ...

An exploration of risk management in global industrial investment

This article explores risk management in global industrial investment by identifying linkages and gaps between theories and practices. It identifies opportunities for further development of the field. Three related bodies of literature have been reviewed: risk management, global manufacturing and investment. The review suggests that risk management in global manufacturing is overlooked in the literature; that existing theoretical risk management processes are not well developed in the global manufacturing context and that the investment literature applies mainly to financial risk assessment rather than investment risk management structures. Further, there appears to be a serious lack of systematic industrial risk management in investment decision making. This article highlights the opportunities to deploy current good practices more effectively as well as the need to develop more robust theories of industrial investment risk management. The approach adopted to investigate this multidisciplinary topic included a historical review of literature to understand the diverse background of theoretical development. A case study research approach was adopted to collect data, involving four global manufacturing companies and one risk management advisory company to observe the patterns and rationale of current practices. Supporting arguments from secondary data sources reinforced the findings. The research focuses risk management in global industrial investment. It links theories with practice to understand the existing knowledge gap and proposes key research themes for further research. © 2013 Macmillan Publishers Ltd. 1460-3799 Risk Management.