Beginning with the foundations of community development, An Introduction to Community Development offers a comprehensive and practical approach to planning for communities. Road-tested in the authors’ own teaching, and through the training they provide for practicing planners, it enables students to begin making connections between academic study and practical know-how from both private and public sector contexts. An Introduction to Community Development shows how planners can utilize local economic interests and integrate finance and marketing considerations into their strategy. Most importantly, the book is strongly focused on outcomes, encouraging students to ask: what is best practice when it comes to planning for communities, and how do we accurately measure the results of planning practice? This newly revised and updated edition includes: increased coverage of sustainability issues, discussion of localism and its relation to community development, quality of life, community well-being and public health considerations, and content on local food systems. Each chapter provides a range of reading materials for the student, supplemented with text boxes, a chapter outline, keywords, and reference lists, and new skills based exercises at the end of each chapter to help students turn their learning into action, making this the most user-friendly text for community development now available.

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.