Clinical Operations-Design to Execution

BayBiotech.NET In current times demands on laboratory performance are becoming more intensive as the number of new tests and diseases are adding on to our list as well as a greater demand for accuracy in test results is increasing by a much more controlled regulatory environment. In order to meet these demands, laboratory personnel are working on an ongoing basis to improve efficiency and productivity through better control over the operation and function of all aspects of the testing process by incorporating automation and use of computerized system wherever possible. Creation of an efficient Workflow helps make the entire process cost effective and efficient and a framework for creating a workflow may include: 1. Understanding the issues relating to creating a work list 2. Describe ways to minimize laboratory contamination 3. Understand ways to improve labor efficiency 4. Understand key variables that contribute to testing accuracy  Explain the importance of sensitivity ...

BayBiotech.NET The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. eCTD technical document format development was done by International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Details on the specification for the ICH eCTD can be found in the guidance document M2 eCTD: Electronic Common Technical Document Specification. Currently, eCTD is the preferred format for electronic submissions by U.S. Food and Drug Administration. Although originally the CTD and the eCTD were designed for marketing applications, they could apply equally to other submission types, including INDs, master files, advertising material, and promotional labeling. In June 2008, FDA has issued guidelines for organizing the electronic regulatory document filing using the eCTD tools. This guidance discusses issues related to the electronic submission of applications for hum...