Redeeming the Dream
Title | Redeeming the Dream PDF eBook |
Author | David Boies |
Publisher | Penguin |
Pages | 322 |
Release | 2015 |
Genre | Biography & Autobiography |
ISBN | 014751620X |
Previous edition published under the title Redeeming the dream: the case for marriage equality.
Large Meteorite Impacts and Planetary Evolution V
Title | Large Meteorite Impacts and Planetary Evolution V PDF eBook |
Author | Gordon R. Osinski |
Publisher | Geological Society of America |
Pages | 236 |
Release | 2015-10-22 |
Genre | Science |
ISBN | 0813725186 |
In this volume, the geologic and planetary science communities explore impact events and how they affected the evolution of Earth and other planetary bodies. these papers are the outcome of a conference held every five years.
Current Challenges in Pharmacovigilance
Title | Current Challenges in Pharmacovigilance PDF eBook |
Author | World Health Organization |
Publisher | |
Pages | 381 |
Release | 2001-01-01 |
Genre | Medical |
ISBN | 9789290360742 |
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.
Catalog of Copyright Entries. Part 1. [B] Group 2. Pamphlets, Etc. New Series
Title | Catalog of Copyright Entries. Part 1. [B] Group 2. Pamphlets, Etc. New Series PDF eBook |
Author | Library of Congress. Copyright Office |
Publisher | |
Pages | 1114 |
Release | 1982 |
Genre | |
ISBN |
Building Better Governance
Title | Building Better Governance PDF eBook |
Author | |
Publisher | |
Pages | 86 |
Release | 2007 |
Genre | Administrative agencies |
ISBN | 9780980397864 |
The Global Exploration Roadmap
Title | The Global Exploration Roadmap PDF eBook |
Author | Isecg |
Publisher | |
Pages | 50 |
Release | 2013-10-24 |
Genre | |
ISBN | 9781457849107 |
Agencies participating in the International Space Exploration Coordination Group (ISECG) continue to advance a long-range international exploration strategy that begins with the International Space Station (ISS) and expands human presence in the solar system, leading ultimately to human missions to explore the surface of Mars.The Global Exploration Roadmap, first released in September 2011, has been updated in August 2013 to reflect updated agency plans and programmes as well as continue to facilitate stakeholder engagement in the effort to chart an international roadmap to Mars. Figures. This is a print on demand report.
Franchise Company Data
Title | Franchise Company Data PDF eBook |
Author | United States. Department of Commerce |
Publisher | |
Pages | 86 |
Release | 1965 |
Genre | Franchises (Retail trade) |
ISBN |