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.

Robust pairwise matching of interest points with complex wavelets

We present a matching framework to find robust correspondences between image features by considering the spatial information between them. To achieve this, we define spatial constraints on the relative orientation and change in scale between pairs of features. A pairwise similarity score, which measures the similarity of features based on these spatial constraints, is considered. The pairwise similarity scores for all pairs of candidate correspondences are then accumulated in a 2-D similarity space. Robust correspondences can be found by searching for clusters in the similarity space, since actual correspondences are expected to form clusters that satisfy similar spatial constraints in this space. As it is difficult to achieve reliable and consistent estimates of scale and orientation, an additional contribution is that these parameters do not need to be determined at the interest point detection stage, which differs from conventional methods. Polar matching of dual-tree complex wavelet transform features is used, since it fits naturally into the framework with the defined spatial constraints. Our tests show that the proposed framework is capable of producing robust correspondences with higher correspondence ratios and reasonable computational efficiency, compared to other well-known algorithms. © 1992-2012 IEEE.

Designing climate change mitigation plans that add up.

Mitigation plans to combat climate change depend on the combined implementation of many abatement options, but the options interact. Published anthropogenic emissions inventories are disaggregated by gas, sector, country, or final energy form. This allows the assessment of novel energy supply options, but is insufficient for understanding how options for efficiency and demand reduction interact. A consistent framework for understanding the drivers of emissions is therefore developed, with a set of seven complete inventories reflecting all technical options for mitigation connected through lossless allocation matrices. The required data set is compiled and calculated from a wide range of industry, government, and academic reports. The framework is used to create a global Sankey diagram to relate human demand for services to anthropogenic emissions. The application of this framework is demonstrated through a prediction of per-capita emissions based on service demand in different countries, and through an example showing how the "technical potentials" of a set of separate mitigation options should be combined.

Depicting the future strategic plans of the Royal Australian Navy using a roadmapping framework as a visual composite canvas

Strategic planning can be an arduous and complex task; and, once a plan has been devised, it is often quite a challenge to effectively communicate the principal missions and key priorities to the array of different stakeholders. The communication challenge can be addressed through the application of a clearly and concisely designed visualisation of the strategic plan - to that end, this paper proposes the use of a roadmapping framework to structure a visual canvas. The canvas provides a template in the form of a single composite visual output that essentially allows a 'plan-on-a-page' to be generated. Such a visual representation provides a high-level depiction of the future context, end-state capabilities and the system-wide transitions needed to realise the strategic vision. To demonstrate this approach, an illustrative case study based on the Australian Government's Defence White Paper and the Royal Australian Navy's fleet plan will be presented. The visual plan plots the in-service upgrades for addressing the capability shortfalls and gaps in the Navy's fleet as it transitions from its current configuration to its future end-state vision. It also provides a visualisation of project timings in terms of the decision gates (approval, service release) and specific phases (proposal, contract, delivery) together with how these projects are rated against the key performance indicators relating to the technology acquisition process and associated management activities. © 2013 Taylor & Francis.