Links


	http://www.fda.gov/
	Web site of FDA’s Office of Regulatory Affairs (ORA). Official information on regulatory activities of the FDA.

	www.access.gpo.gov/nara/cfr/waisidx_02/21cfr11_02.html
	All chapters of 21 CFR part 11 for individual download.

	http://www.emea.eu.int/
	European Medicines Evaluation Agency.

	http://www.pheur.org
	European Directorate for the Quality of Medicines.

	http://www.ich.or
	The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

	http://www.oecd.org/
	OECD publications on environment, health, chemical safety, GLP and compliance monitoring.

	http://www.dggf.de
	The target of the “German Society for Good Research Practice” (DGGF e.V.) is to facilitate the exchange of scientific informations and -opinions to all questions concerning the quality assurance of pharmaceutic-chemical Industries and adjacent fields. The members of the DGGF are from different research- and development departments in industry, contract research organisations, clinical laboratories and –departments as well as industry laboratories, hospitals and authorities. Besides the colleagues of quality assurance departments the DGGF also combines study directors and investigators, leaders of testing facilities, archivists, monitors and others – all of them with the same interest in a good quality in their scope of duties. The Society informs their members about current considerations in quality assurance, validation and official requirements at the annual conference of the Society, in newsletters and expert groups.