EU Directives, Regulations, & Guidelines.
EU directives lay down certain end results that must be achieved in every Member State. National authorities have to adapt their laws to meet these goals, but are free to decide how to do so. Directives may concern one or more Member States, or all of them.
Each directive specifies the date by which the national laws must be adapted, giving national authorities the room for manoeuvre within the deadlines necessary to take account of differing national situations.
Directives are used to bring different national laws into line with each other, and are particularly common in matters affecting the operation of the single market.
Code of Federal Regulations. The Code of Federal Regulations is a regularly updated, unofficial editorial compilation of CFR material and Federal Register amendments produced by the National Archives and Records Administration's Office of the Federal Register (OFR) and the Government Printing Office.
Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts. The clinical research community often underestimates the impact the use of electronic applications and computerized systems as well as the transmission of subject data may bring to the quality and integrity of data and the impact it may have on subject safety. This text applies and further develops the standards set forth through the Red Apple II GLP DIA initiative. This initiative is intended to set a benchmark for requirements of computerized systems used in clinical research. It is simultaneously intended to support the many users struggling to implement validation processes into clinical research, thus stimulating innovation in the clinical research environment.
DIA members click here to purchase at the special member rate.
Non-members click here to purchase.
Computerized Data Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance.
This second edition explores the current environment and new challenges in the development, validation, and use of computerized systems in nonclinical laboratories and describes the best practices to ensure their quality at that time.
FDA Presentations. DIA provides a visible and prestigious platform for policymakers at the forefront of innovation in health care and medical devices. Policy and regulatory professionals at all stages of their careers turn to DIA to disseminate cutting-edge information as well as to stay current on the latest industry information through DIA knowledge sharing programs.