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Advanced Linux Programming
This is the eBook version of the printed book. If the print book includes a CD-ROM, this content is not included within the eBook version. Advanced Linux Programming is divided into two parts. The first covers generic UNIX system services, but with a particular eye towards Linux specific information. This portion of the book will be of use even to advanced programmers who have worked with other Linux systems since it will cover Linux specific details and differences. For programmers without UNIX experience, it will be even more valuable. The second section covers material that is entirely Linux specific. These are truly advanced topics, and are the techniques that the gurus use to build great applications. While this book will focus mostly on the Application Programming Interface (API) provided by the Linux kernel and the C library, a preliminary introduction to the development tools available will allow all who purchase the book to make immediate use of Linux.
Current Challenges in Pharmacovigilance
In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Learning and Expanding with Activity Theory
Author: Anna Lisa Sannino
language: en
Publisher: Cambridge University Press
Release Date: 2009-08-17
This book is a collection about cultural-historical activity theory as it has been developed and applied by Yrjö Engeström. The work of Engeström is both rooted in the legacy of Vygotsky and Leont'ev and focuses on current research concerns that are related to learning and development in work practices. His publications cross various disciplines and develop intermediate theoretical tools to deal with empirical questions. In this volume, Engeström's work is used as a springboard to reflect on the question of the use, appropriation, and further development of the classic heritage within activity theory. The book is structured as a discussion among senior scholars, including Y. Engeström himself. The work of the authors pushes on classical activity theory to address pressing issues and critical contradictions in local practices and larger social systems.