DATA BASE;
DRUG INFORMATION;
DRUG SAFETY;
DRUG SURVEILLANCE PROGRAM;
FOOD AND DRUG ADMINISTRATION;
INTERNET;
PRACTICE GUIDELINE;
PRIORITY JOURNAL;
REVIEW;
ADVERSE DRUG REACTION REPORTING SYSTEMS;
CONFIDENTIALITY;
CONSUMER PRODUCT SAFETY;
DRUG APPROVAL;
DRUG INDUSTRY;
EUROPE;
HUMANS;
INTERNATIONAL COOPERATION;
INTERNET;
JAPAN;
PERIODICALS;
PRODUCT SURVEILLANCE, POSTMARKETING;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
WORLD HEALTH ORGANIZATION;
Zakon RH. Hobbes' Internet Timeline v4.0 [online]. Available from: URL: http://info.isoc.org/guest/zakon/Internet/History/Hit.html [Accessed 1999 Jan 6]
Spring. Bridgewater (NJ): Taratec Development Corporation (data on file)
Brown E. Straight talk: what is validation? PROTOCOL, A Validation Industry Quarterly Newsletter, Spring 1996. Bridgewater (NJ): Taratec Development Corporation (data on file)
US code of federal regulations: 21 chapter I part II electronic records
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US Code of Federal Regulations: 21 Chapter I Part II Electronic Records; Electronic Signatures [online]. Available from: URL: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html [Accessed 1998 Dec 21]
EC council directive 92/28/EEC concerning the advertising of medicinal products for human use
[online]. [Accessed 1998 Dec 21]
EC Council Directive 92/28/EEC Concerning the Advertising of Medicinal Products for Human Use. Official Journal of the European Communities, 1992, L113, 13 [online]. Available from: European Union Document Delivery Service http://eudor.eur-op.eu.int/ [Accessed 1998 Dec 21]
Center for Drug Evaluation and Research. Reporting regulations and guidances [online]. Available from: URL: http://www.fda.gov/cder/aers/regs.htm [Accessed 1998 Dec 21]
DG III-E-3Telematics Projects in Pharmaceuticals and Cosmetics [online]. Available from: URL: www3.is.eudra.org/telemat/index.htm [Accessed 1998 Dec 21]
E2B Clinical Safety Data Management: Data Elements for Transmission of Individual Case Reports. CPMP/ICH/287/95 [online]. Available from: URL: www.ich.org/ich5e.html#Safety [Accessed 1998 Dec 21]
International conference on harmonisation; Guidance on data elements for transmission of individual case safety reports
International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case Safety Reports. US Federal Register 1998; 63 (10): 2396-2404
Center for Drug Evaluation and Research. AERS: concept of operations [online]. Available from: URL: http://www.fda.gov/cder/aers/concept.htm [Accessed 1998 Dec 21]