Academic literature on the topic 'Pharmaceutical Management Agency'

The authors describe the pharmaceutical utilization system and present the conceptual framework for agency theory. They then apply agency theory to the selection of pharmaceuticals and the role of drug formularies in drug selection. The use of drug formularies can increase the goal conflict and uncertainty related to the selection of drug products. The authors address public policy and research directions to suggest ways of reducing the level of goal conflict and uncertainty associated with drug selection. Recognition of agency relationships and the environment surrounding agency relationships appear to be important for the development and analysis of future policy regarding selection decisions pertaining to pharmaceuticals.

Drugs must be produced in compliance with good manufacturing practice rules approved by an authorized federal agency. Pharmaceutical Quality System is a global requirement for development and production processes for pharmaceutical products. The article describes a variant of automated document management system of pharmaceutical manufacturer’s quality management system in accordance with current requirements of GMP. The peculiarity of the proposed system is the focuses on pharmaceutical production taking into account the characteristics and requirements for the pharmaceutical products production. All documents which are supposed to be used within the system are grouped into the four blocks: normative legal acts, core manufacturer standards according to GMP, regulatory documents, and register documents.

Most of studies imply that firms decrease or increase their debt capacity in context of pecking order theory or agency problems. On this point, the setting of this study is based on two main problems related to capital structure: the first is determining the source of funds for financing investments, and the second is solving the conflict between shareholders and managers, or the agency problem. The objective of this study is to provide evidence about how firms establish their capital structure in relation to pecking order theory and the agency problem by controlling earnings management in the context of Indonesian firms. This study conducts logistic regression on 28 firms in the consumer goods industry listed on the Indonesia Stock Exchange from 2010 to 2017.This study finds that pecking order theory determines the capital structure of most Indonesian firms with high debt. The results imply that agency problems are unable to explain corporate capital structure and earnings management is not effective for motivating Indonesian firms to establish corporate governance.

Today the management of solid waste and wastewater is a major concern for humanity. In the last decade, traces of pharmaceuticals have been reported in the water cycle and have raised concerns among regulators, water suppliers and the public regarding the potential risks to human health. This study evaluated solid waste management in the state of Minas Gerais and concluded that the main fate of hazardous waste has been incineration, while the non-hazardous waste has been recycled or sent to landfills. However, complaints to the Environmental Agency - FEAM have indicated that a significant number of companies just send their hazardous wastes to landfills or even to garbage dumps, thus highlighting the urgent need for adequate waste management in Minas Gerais. Most of the pharmaceutical companies in Minas Gerais use conventional wastewater treatment. Mass spectrometry with electrospray ionization (ESI-MS) showed that the treatment routes adopted by the two 2 selected pharmaceutical industries were not effective enough since residues and degradation products of antibiotics were detected. The physicochemical analysis of the effluents showed variability in their characteristics, which may influence their treatability. The degradation assay with Fenton's reagent stood out as a promising route in achieving a higher removal capacity compared to the conventional treatment. This study contributes to enhancing our knowledge of the management of wastewater as well as of solid waste from the pharmaceutical industry in Minas Gerais and points out the need for further research.

During the past two decades scientists, regulatory agencies and the European Commission have acknowledged pharmaceuticals to be an emerging environmental problem. In parallel, a regulatory framework for environmental risk assessment (ERA) of pharmaceutical products has been developed. Since the regulatory guidelines came into force the German Federal Agency (UBA) has been evaluating ERAs for human and veterinary pharmaceutical products before they are marketed. The results show that approximately 10% of pharmaceutical products are of note regarding their potential environmental risk. For human medicinal products, hormones, antibiotics, analgesics, antidepressants and antineoplastics indicated an environmental risk. For veterinary products, hormones, antibiotics and parasiticides were most often discussed as being environmentally relevant. These results are in good correlation with the results within the open scientific literature of prioritization approaches for pharmaceuticals in the environment. UBA results revealed that prospective approaches, such as ERA of pharmaceuticals, play an important role in minimizing problems caused by pharmaceuticals in the environment. However, the regulatory ERA framework could be improved by (i) inclusion of the environment in the risk–benefit analysis for human pharmaceuticals, (ii) improvement of risk management options, (iii) generation of data on existing pharmaceuticals, and (iv) improving the availability of ERA data. In addition, more general and integrative steps of regulation, legislation and research have been developed and are presented in this article. In order to minimize the quantity of pharmaceuticals in the environment these should aim to (i) improve the existing legislation for pharmaceuticals, (ii) prioritize pharmaceuticals in the environment and (iii) improve the availability and collection of pharmaceutical data.

Australia and New Zealand have agreed in principle to the creation of a single agency for the regulation of pharmaceuticals and other therapeutic products in a trans-Tasman market. The Australia New Zealand Therapeutic Products Authority (ANZTPA) is being developed to replace both the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). This article explores the possibility that the ANZTPA, by inheriting significant obligations imposed on the TGA under the Australia-United States Free Trade Agreement (AUSFTA), may significantly impact upon the regulation of medicines and medical devices (as well as blood products) in New Zealand. It explores the related legal obligations and their likely consequences for New Zealand: particularly quality, safety, efficacy and cost-effectiveness evaluation processes in this area, such as those of the New Zealand Pharmaceutical Management Agency (Pharmac).

This study aims to examine the impact of minority investor protection mechanisms on agency costs. All relevant indicators of minority investor protection adapted from the World Bank’s annual ‘Doing Business’ reports, along with concentrated government ownership, are employed with a panel data sample of 135 Vietnamese listed firms during the period 2014–2018. It is found that the following mechanisms are effective in mitigating agency costs and hence agency problems at the firm level: 1) review and approval requirements for related-party transactions; 2) minority shareholders’ ability to sue and hold directors liable for their duties; 3) minority shareholders’ access to internal corporate documents; 4) investors’ rights to approve major corporate investment and sale of asset decisions; and 5) disclosure in annual reports of salaries, bonuses and other forms of remuneration to directors and management. Interestingly, board independence and controlling government shareholders are not confirmed to play significant roles in addressing agency problems. To the best of the authors’ knowledge, this is the first attempt at testing for the impact of minority investor protection mechanisms developed by the World Bank on agency costs at the firm level, hence providing empirical evidence for the adoption of the minority investor protection mechanisms promoted by the World Bank. This study also provides policy implications for selecting effective mechanisms to mitigate agency conflicts between controlling shareholders and minority investors in order to enhance the financial performance of firms in an Asian emerging market.

IntroductionThe specificities of non-pharmaceuticals can require adapting classical health technology assessment (HTA) methodologies and developing additional regional approaches to support decision-making processes. However, little information exists regarding the explicit approaches used in different countries. The aim of this work is to provide an overview of the role and activities of the Galician HTA agency (avalia-t, Spain) regarding assessment, appraisal and continued evaluation across the whole life cycle of non-pharmaceutical technologies.MethodsIn depth review and analysis of the activities undertaken by avalia-t during the past five years to support the introduction and appropriate use of non-pharmaceutical health care technologies at the regional level.ResultsA multidisciplinary Commission judges the added value of new non-pharmaceuticals and establishes the indications and conditions for use. HTAs, which are mandatory for all relevant technologies, rely on the best available evidence on safety and effectiveness but also provide fit for purpose contextualized information based on organizational data and administrative registers. Interaction with multidisciplinary stakeholders is commonly needed to complement the evidence base (ad hoc working groups, face to face discussions), and post-launch studies can be implemented to analyze the utilization and results in real world practice. Performance indicators and other HTA based products can also be required to ensure the quality of health care (e.g., appropriate use indications, quality indicators, evidence based patient information). In addition, technical and scientific advice/support can be provided at different decision levels of the health organization to promote the quality of care and appropriate use of technologies (e.g., regional mental health program, suicide management strategy, bariatric surgery surveillance registry).ConclusionsRigorous, comprehensive and systematic processes for supporting non-pharmaceutical technology adoption and implementation are required. Although it is acknowledged that core information does not differ substantially within countries, contextualized information is recognized as essential for establishing the conditions for use at the regional level.

The human capital of corporate boards of directors is a key organizational resource affecting a variety of strategic outcomes. Using human capital theory within the broader theoretical contexts of agency theory and the resource dependence perspective, we investigate the effects of certain types of board human capital on firm innovation. Our findings are generally supportive of our theory that board human capital is associated with firm innovation. Specifically, we examine the role of certain types of board human capital on firm innovation and find that scientific expertise, industry experience, financial expertise, and women directors positively affect firm innovation in the pharmaceutical industry, with innovation measured by R&D expenditures and number of patents. These results imply that the knowledge, experience, and expertise that directors bring to corporate boards are important considerations in constituting corporate boards. Further, our work adds to understanding of the impact of board characteristics on firm strategic outcomes.

Background: In September 2001, in addition to their existing management of primary care pharmaceutical expenditure, PHARMAC, the New Zealand government�s Pharmaceutical Management Agency, was authorized to manage pharmaceutical expenditure in public hospitals.[1] In February 2002 PHARMAC launched a three-part Strategy, the National Hospital Pharmaceutical Strategy (NHPS), for this purpose.[2] The Strategy focused on Price Management (PM), the Assessment of New Medicines (ANM), and promoting Quality in the Use of Medicines (QUM). Major initiatives planned were: for PM, to negotiate new, national (as opposed to current, local) contracts for frequently used pharmaceuticals; for ANM, to provide economic assessments of new hospital medicines; and for QUM, to coordinate activities in hospitals. Aims: To assess the impact of each of the three parts of the National Hospital Pharmaceutical Strategy, and assess any impact of the Strategy�s new contracts on the availability of those medicines. Methods: Price Management was assessed in 2003, 2004 and 2005 using data from eleven selected hospitals to estimate savings for all 29 major hospitals, and by tracking hospital pharmaceutical expenditure from 2000 to 2006. For other aspects, cross-sectional surveys were administered to chief pharmacists at all hospitals employing a pharmacist; 30 hospitals in 2002, 29 in 2004. Surveys were undertaken in 2002 and 2004 to examine ANM and QUM activity in hospitals before and after the Strategy. Surveys were undertaken in 2004 and 2005 to examine any changes in the availability of medicines on new contracts, in hospitals. In 2005 a survey was undertaken of opinions on PHARMAC�s specially-developed pharmacoeconomic (PE) assessments. Results: PM results indicated that, by 2006, savings of $7.84-13.45m per annum (6-8%) had been made on hospital pharmaceutical expenditure, and growth in inpatient pharmaceutical expenditure appeared to slow for all types of hospitals in 2003/4. ANM surveys indicated that, by 2004, hospital new medicine assessment processes, predominantly formal, became more complex, more focused on cost-effectiveness, and the use of pharmacoeconomic information increased. The PE survey indicated that PHARMAC�s economic assessments of new medicines were mainly viewed favourably but were not sufficiently timely to be widely used in hospital formulary decisions. Availability surveys indicated that new contracts occasionally caused availability problems e.g. products that were "out of stock", or products considered inferior by respondents. Problems were usually resolved within weeks, but some took over a year. QUM activities showed little change between surveys, but during the period an independent organisation was formed by the District Health Boards of New Zealand, with representation from PHARMAC, to coordinate the Safe and Quality Use of Medicines in New Zealand. Conclusion: The National Hospital Pharmaceutical Strategy has been moderately successful in New Zealand. Savings of NZ$7.84-13.45m per annum were made, and growth in inpatient pharmaceutical expenditure appeared to slow in the year following the Strategy�s launch. The study has indicated some important short-term effects from the Strategy, but further research is needed to ensure that favourable effects are sustained and unfavourable effects kept to a minimum. Similar, centralized, multifaceted, approaches to managing pharmaceutical expenditure may be worth considering in other countries. 1. New Zealand Parliament. New Zealand Public Health and Disability Act. In: The Statutes of New Zealand 2000. No 91.Wellington: New Zealand Parliament; 2000 2. Pharmaceutical Management Agency. National Hospital Pharmaceutical Strategy Final Version. Wellington: PHARMAC; 2002

Known as direct-to-consumer advertising (DTCA), pharmaceutical companies in the United States are permitted to advertise prescription drugs directly to consumers. The purpose of this quantitative study was to determine if an association exists between DTCA and health care-seeking behaviors. The theoretical framework for this study involved social learning theory, information integration theory, and prospect theory. The research questions identified if exposure to DTCA (a) is associated with physician office visits, (b) influences a patient/physician conversation regarding a prescription, (c) influences requesting a prescription, and (d) has an impact on patients' ratings of the overall interaction with the physician. Data were derived from an online survey adapted from the U.S. Food and Drug Administration. Participants included 235 college-affiliated adults. Data were analyzed using descriptive statistics and analysis of variance. The Bonferroni correction was used to control the family-wise Type I error rate. The most significant findings of this study are that DTCA is associated with patients asking more questions, having more office visits, and patients having a lower overall health status. Future researchers should consider a non-college-affiliated sample and the post-implementation impact of the Affordable Care Act. This study helps to address the community challenges of how DTCA impacts prescription drug use and costs, as well as patients' understanding of the associated risks. Having knowledge of the impact of DTCA can help patients and their communities, employers, and governments make more informed decisions that will positively impact their health, wellbeing, and prescription expenses.

Thesis (MBA)--Stellenbosch University, 2004.
ENGLISH ABSTRACT: HIV infection has increased sharply in SA over the past decade, from almost zero to a level where between 4-6 million citizens are estimated to be HIV positive (i.e. around Il percent of the total population). Given the considerable lag and link between the HIV and AIDS epidemic, the mortality consequences of this exponential increase in HIV infection over the 1990s are more or less matter-of-fact over the coming decade; even drastic interventions can do little to avoid this reality, albeit possibly impactingfurther beyond. The health care industry, and more specifically the pharmaceutical industry, is the only industry that can have a direct impact on the outcome of the epidemic in terms of provision of antiretroviral drugs. More importantly, the decision by multinational companies to provide voluntary licensing to local SA pharmaceutical manufacturers for the manufacturing of generic ARVs has gone a long way into achieving the World Health Organisations' objective of providing an ARV cocktail for less than $1,00 per day. The mam aim of the study is to establish and study the micro-economic effect of HIV/AIDS on a South African pharmaceutical manufacturer and to evaluate their HIV/AIDS Policy with the framework of the mV/AIDS & SID Strategie Plan for South Africa 2000-2005. Both qualitative and quantitative methods were used to obtain data from various key informants, manufacturers and market survey companies. The analysis of quantitative data was done using Excel software and a descriptive analysis method was used to interpret the data. The key findings from the study are that Aspen Pharmacare will experience a 20,8 % HIV prevalence rate in 2005, which will progressively increase to a 25,6 % level in 2015. This prevalence level will be severely experienced in the skilled, semi-skilled and unskilled employment of the company during the 2010 period and will start to stabilise in the latter part of 2015. The AIDS prevalence in the company will increase from a 2,0 % level in 2005 to a 4,4 % level in 2015. This increase is largely due to the increase in the prevalence rates in the semi-skilled and unskilled employees. At a senior management level the forecasted number of employees that will have clinical AIDS after 2010 is between 6 and 8. This clearly indicates that mv/AIDS prevalence at this level is independent of race and is lifestyle dependent. If the company were to have the full responsibility for the provision of benefits, based on the current expected employee benefit structures, the direct cost to company would add 10 % to salary and wages by 2005 and around 20 % by 2010. Indirect costs to company, such as recruitment and training, increased labour turnover, lost skills and intellectual property, etc. are estimated to be 2,5 % by 2005 and 5 % by 2010. With the high HIV/AIDS prevalence rates, especially amongst the unemployed, companies will have to carry the costs of their mv/AIDS patients for longer and register then with Aid for AIDS when it becomes too costly. More importantly employers will have to investigate the cost implication of assisting employee dependents, as this will have a direct impact on the morale of the employees. Aspen Pharmacares' mv/AIDS Policy goes beyond the requirements of the mv/AIDS Strategic Plan for SA in terms of the legal and social requirements. The company also has a Corporate Social Investment division that assists many NGOs, clinics, hospitals and communities. Based on the intellectual property, the pharmaceutical competencies and the continuous dialogue that exists between the pharmaceutical industry and the department of health, the researcher concludes, that pharmaceutical companies have an advantage over nonpharmaceutical companies in dealing with the mv/AIDS issues. The paper concludes by suggesting recommendations that companies can adopt to ensure that their mv/AIDS policy can form a significant component of their skills retention strategy.
AFRIKAANSE OPSOMMING: MIV infeksie het skerp gestyg in SA oor die laaste dekade, vanaf amper geen tot 'n vlak waar tussen 4-6 miljoen inwoners beraam word om MIV positiefte wees (minstens 11% van die totale bevolking). Gegee die aansienlike vertraging en skakel tussen die MIV en VIGS epidemie, word die eksponensiële toename in die sterfte syfer as gevolg van MIV infeksies gedurende die jare negentig as vanselfsprekend aanvaar in die komende dekade. Selfs ingrypende veranderinge kan min doen om hierdie katastrofe te keer. Die gesondheidsorg industrie, en meer spesifiek die farmaseutiese industrie is die enigste industrie wat 'n direkte slag kan slaan om die uitkoms van die epidemie te beinvloed, in terme van voorsiening van antiretrovirale medisyne. Die besluit van die multinasionale maatskappye om vrywillige lisensiëring aan plaaslike farmaseutiese maatskappye te bied, vir die vervaardiging van generiese antiretrovirale medisyne, is een stap vorentoe om by die doelwit van die Wereld Gesondheidsorg Organisasie se doelwit van die voorsiening van 'n daaglikse toediening van antiretrovirale medisyne van minder as $1.00 per dag. Die primêre doelwit van hierdie projek is om te bepaal wat die mikro-ekonomiese effek van MIV/VIGS op 'n Suid Afriakaanse farmaseutiese vervaardiger is en hul MIV/VIGS beleid te evalueer binne die raamwerk van die MIV/VIGS en SOS Strategiese Plan vir SA 2000-2005. Beide kwalitatiewe en kwantitatiewe metodes is gebruik om data te verkry vanaf verskeie bronne, vervaardigers en marknavorsings maatskappye. Die kwantitatiewe inligting was geanaliseer deur gebruik te maak van "Excel" sagteware en 'n beskrywende analitiese metode was gebruik om die data te interpreteer. Die hoof bevindinge van die studie is dat Aspen Pharmacare 'n MIV infeksie vlak van 20.8 % in 2005 sal ondervind, wat progressief sal toeneem tot 25,6 % in 2015. Hierdie infeksie vlak sal in die geskoolde, semi-geskoolde en ongeskoolde arbeid die ergste voorkom gedurende die 2010 periode en sal dan stabiliseer in die latere gedeelte van 2015. Die VIGS infeksie vlak in die maatskappy sal toeneem vanaf 2,0 % in 2005 tot 'n 4,4 % in 2015. Hierdie toename kan toegeskryf word aan die toename in die infeksie vlakke van die semi-geskoolde and ongeskoolde arbeid. Op die senior bestuurs vlak word beraam dat tussen 6 en 8 werknemers VIGS onder lede sal hê na 2010. Hierdie beraming toon duidelik aan dat MIV/VIGS op hierdie vlak onafhankilik van kleurgroup is en direk leefstyl verwant is. Gebaseer op die huidige verwagte werknemer voordele struktuur, en die feit dat die maatskappy volle verantwoordelikheid sou aanvaar vir die voorsiening van voordele, word beraam dat die direkte koste as gevolg van MIV/VIGS 'n toename van 10 % in 2005 en 20 % in 2010 by salarisse en lone sal voeg. 'n Toename van 2,5 % in 2005 en 5 % in 2010 word beraam vir indirekte koste (werwing van personeel, opleiding, ens.)as gevolg van MIV/VIGS. Met die hoë MIV/VIGS infeksievlakke, veral onder werkloses, sal maatskappye die kostes vebonde aan hul MIV/VIGS werknemers vir langer moet verduur en dan later sulke werknemers registreer by "Aid for AIDS" indien dit onbekostigbaar word. Belangriker is die feit dat werknemers die koste implikasie bepaal in die verband, omdat dit 'n direkte invloed sal hê op werknemer selfvertroue. Aspen Pharmacare se MIV/VIGS beleid bied meer as die wettige en sosiale vereistes soos uiteengesit in die MIV/VIGS en SOS Strategiese Plan vir SA 2000-2005. Die maatskappy het ook 'n Korporatiewe Maatskaplike Beleggings afdeling wat 'n bydra lewer by NGOs, klinieke,hospitale en gemeenskappe. Gebaseer op die intelligensie eiendom, die farmaseutiese bekwaamheid en die aanhoudende gesprekvoering wat bestaan tussen die farmaseutiese bedryf en die department van gesondheid, oortuig die navorser dat farmaseutiese maatskappye 'n voordeel het bo nie-farmaseutiese maatskappye in die hantering van die MIV/VIGS strydvraag. Hierdie studie sluit af met aanbevelings wat maatskappye kan toepas om te verseker dat hul MIV/VIGS beleid 'n betekenisvolle komponent van hul bekwaanheids retensie strategie is.

Sex-specific effects in the clinical presentation and course of bipolar disorder in women have important treatment implications for the management of symptoms across the menstrual cycle and reproductive lifespan. Women with bipolar disorder are particularly vulnerable to premenstrual mood symptoms, menstrual abnormalities, and polycystic ovary syndrome. Special considerations include understanding the interactions between these reproductive issues, oral contraceptives, and mood-stabilizing agents. Additionally, the management of bipolar disorder during the perinatal period requires a careful approach to psychotropic medication to optimize the maintenance of mood stability while minimizing the potential for adverse risk of fetal and neonatal outcomes. Non-pharmaceutical approaches, including electroconvulsive therapy, transcranial magnetic stimulation, selected psychotherapies, and social and behavioural interventions may represent efficacious treatment options to reduce medication burden. Lastly, women with bipolar disorder may be at particular risk for worsening of affective symptoms during the menopausal transition, and strategies to reduce sleep disruption are imperative.

Abstract Since the discovery of RNA interference in 1998 as a potent molecular tool for the selective downregulation of gene expression in almost all eukaryotes, increasing research is being performed in order to discover applications that are useful for the pharmaceutical and chemical industry. The ease of use of double-stranded RNA for targeted in vivo gene silencing in animal cells and tissues gave birth to a massive interest from industry in order to discover biotechnological applications for human health and plant protection. For insects, RNAi became the 'Holy Grail' of pesticide manufacturing, because this technology is a promising species-specific environmentally friendly approach to killing natural enemies of cultured plants and farmed animals. The general idea to use RNAi as a pest-control agent originated with the realization that dsRNAs that target developmentally or physiologically important insect genes can cause lethal phenotypes as a result of the specific gene downregulation. Most importantly to achieve this, dsRNA is not required to be constitutively expressed via a transgene in the targeted insect but it can be administrated orally after direct spraying on the infested plants. Similarly, dsRNAs can be administered to pests after constitutive expression as a hairpin in plants or bacteria via stable transgenesis. Ideally, this technology could have already been applied in integrated pest management (IPM) if improvements were not essential in order to achieve higher insecticidal effects. There are many limitations that decrease RNAi efficiency in insects, which arise from the biochemical nature of the insect gut as well as from deficiencies in the RNAi core machinery, a common phenomenon mostly observed in lepidopteran species. To overcome these obstacles, new technologies should be assessed to ascertain that the dsRNA will be transferred intact, stable and in high amounts to the targeted insect cells. In this chapter we will review a wide range of recent discoveries that address the delivery issues of dsRNAs in insect cells, with a focus on the most prominent and efficient technologies. We will also review the upcoming and novel use of viral molecular components for the successful and efficient delivery of dsRNA to the insect cell.

Abstract Since the discovery of RNA interference in 1998 as a potent molecular tool for the selective downregulation of gene expression in almost all eukaryotes, increasing research is being performed in order to discover applications that are useful for the pharmaceutical and chemical industry. The ease of use of double-stranded RNA for targeted in vivo gene silencing in animal cells and tissues gave birth to a massive interest from industry in order to discover biotechnological applications for human health and plant protection. For insects, RNAi became the 'Holy Grail' of pesticide manufacturing, because this technology is a promising species-specific environmentally friendly approach to killing natural enemies of cultured plants and farmed animals. The general idea to use RNAi as a pest-control agent originated with the realization that dsRNAs that target developmentally or physiologically important insect genes can cause lethal phenotypes as a result of the specific gene downregulation. Most importantly to achieve this, dsRNA is not required to be constitutively expressed via a transgene in the targeted insect but it can be administrated orally after direct spraying on the infested plants. Similarly, dsRNAs can be administered to pests after constitutive expression as a hairpin in plants or bacteria via stable transgenesis. Ideally, this technology could have already been applied in integrated pest management (IPM) if improvements were not essential in order to achieve higher insecticidal effects. There are many limitations that decrease RNAi efficiency in insects, which arise from the biochemical nature of the insect gut as well as from deficiencies in the RNAi core machinery, a common phenomenon mostly observed in lepidopteran species. To overcome these obstacles, new technologies should be assessed to ascertain that the dsRNA will be transferred intact, stable and in high amounts to the targeted insect cells. In this chapter we will review a wide range of recent discoveries that address the delivery issues of dsRNAs in insect cells, with a focus on the most prominent and efficient technologies. We will also review the upcoming and novel use of viral molecular components for the successful and efficient delivery of dsRNA to the insect cell.

Following 9/11 and the subsequent anthrax attacks, the U.S. government enlisted the public health industry in homeland security and defense, bringing weapons like disease surveillance and life science research to the war against terrorism. As Congress poured out funding for bioterrorism preparedness, agencies like the Centers for Disease Control and Prevention rearranged themselves around new logics of biosecurity. In the decade after 9/11, CDC brought its surveillance, science, and communication practices to bear on questions of national security, and became a federal organizing agency for emergency response and pharmaceutical stockpile stewardship. The political transformations at the CDC exemplify how bioterrorism changed the role of government in disease management, along with the specific work of the nation’s largest public health agency.

This chapter considers management of uncertainty in drug approval. In the United States, the approval process of the Food and Drug Administration (FDA) determines whether a drug can legally be sold within the country. A similar process occurs in the European Union, with approval performed by the European Medicines Agency. To obtain approval for a new drug, a pharmaceutical firm must provide to the FDA information on treatment response through the performance of randomized trials that compare the new drug with an existing treatment or a placebo. The FDA makes a binary (yes/no) approval decision after reviewing the findings of these trials. Approval decisions are made with incomplete knowledge of the effectiveness and side effects of new drugs. The chapter describes how the FDA deals with uncertainty and suggests how the approval process might be improved.

The question of drug and the improvement of pharmaceutical care services is moving to the front line agenda of policy makers in the healthcare system. The expansion of drug-related problems and medical errors motivated healthcare organizations to focus on the adoption of information systems and technologies in pursuit of improving communications, signaling, analyzing, and reporting of adverse drug reactions and facilitating scenario-based interventions. This chapter focuses on the development of a reference pharmacoinformatics model that can be used to improve the quality of pharmaceutical care provided and the management of hospitals. The material used in this chapter was synthesized to document and analyze the main variables that derive the context of pharmaceutical care in local settings. It also benefited from international data managed by international organizations such as WHO and the information systems used to mine data related to adverse drug events at the level of national Pharmacovigilance Centers. The proposed intelligent multi-agent Pharmacoinformatics decision support model included a process model, a multi-agent architecture, and an integrated data processing model with clear description of agent functionalities. The model reflects three main modules: a data capture and update module, diagnosis module, and a pharmaceutical care and drug monitoring module. The chapter also reflects on the practical and managerial environment of the model and the basic considerations to be taken into account.

The chapter considers issues connected with innovation creation in open innovation model. The knowledge flow in open innovation has been presented. The main “product” of knowledge economy—innovations (as a concept)—are symbolic goods, founded in symbols – not in atoms. This notion causes some consequences typical for information goods, like ease of replication or exchange, zero-marginal replication costs, and cheap storage. On the other hand, there are growing innovation production costs, and uncertainty and risk of innovation activity that discourage companies from being innovative. The idea of open innovation is being used in pharmaceutical industry more and more often in order to cut innovation costs and shorten the new drugs pipelines. One of the most “open” dimensions of innovation activity in pharmaceutical industry is crowdsourcing: a specific sourcing model, an internet-enabled business model that harnesses the creative ability of agents external to organization.