The second edition of Computerized Data Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance 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. It provides the most-up-to-date information on: Computerized systems life cycle; security and integrity of GLP systems and records; and important concepts and trends in the use of computer networks and computerized instruments and equipment in the GLP environment.
EU Directives, Regulations & Guidelines
Selected Directives, Regulations, and Guidelines on Medicinal Products in the European Union (2008)
* Directive 2001/83/ EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use AS AMENDED BY Directives 2002/98/EC, 2003/63/EC, 2004/24/EC, and 2004/27/EC
* Directive 2001/20/ EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
*Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
* Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
* Volume 9A of the Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use (March 2007)
Code of Federal Regulations
Selected Regulations and Guidance on Drugs and Medical Devices in the United States (April 1, 2008-March 31, 2009)
CFR Title 21 Food & Drugs – Revised as of April 1, 2008