Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. Medical books International Pharmaceutical Product Registration . /P>
The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.
This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.
The book is organized into six highly practical segments:
This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan Medical books International Pharmaceutical Product Registration. Categories: Drugs->Law and legislation, Technology, Pharmaceutical->standards. Contributors: Anthony C. Cartwright - Editor. Format: Hardcover
The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.
This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.
The book is organized into six highly practical segments:
This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.
The concept of vulnerability was first presented in Chapter 1 and defined as a measure of the propensity of an object, area, individual, group, community, country, or other entity to incur the consequences of a hazard. As this section illustrates, measurement of vulnerability results from a combination of physical, social, economic, and environmental factors or processes. These factors are the primary determinant features that dictate how the likelihood and/or consequences components of risk are increased or decreased.
It is important to first clarify the difference between the concepts of vulnerability and exposure, which are often confused. The two words are used interchangeably to describe how a country, region, or community is likely to experience a certain hazard. However, this is incorrect, as the discussion on vulnerability factors shows. The United Nation’s risk reduction document Living with Risk embodies this concept, saying, “While most natural hazards may be inevitable, disasters are not” (ISDR, 2004).
 Figure 3-9 |  Figure 3-10 |
While vulnerability defines the propensity to incur consequences, exposure merely suggests that the individual, structure, community, nation, or other subject will be exposed to the hazard. For instance, one might say, “The Spanish are vulnerable to drought,” meaning that Spain regularly experiences the drought hazard. But this statement implies more than the speaker intended. The use of the word “vulnerable” implies that the population is likely to incur negative consequences as a result of factors that make it less likely to protect its citizens and built and natural environments from harm, not simply that drought happens there. The reality, as Figures 3–9 and 3–10 illustrate, is that while Spain is regularly exposed to drought, the nation is not vulnerable to its consequences.
Read the rest of this featured excerpt on Vulnerability. [PDF]
Read a featured excerpt on "Recognizing That Recovery Is an Opportunity in Disguise." [PDF]
Written from a global perspective on risk, hazards, and disasters, Introduction to International Disaster Management provides practitioners, educators and students with a comprehensive overview of the players, processes and special issues involved in the management of large-scale natural and technological disasters. The book discusses special issues encountered in the management of international disasters, and explains the various private, non-governmental, national, and international agencies that assist in preparedness, mitigation, response and recovery during national and regional events.
