Safety reports

California Advisory Board on Air QuaUty and Fuels, Vol. 1, Executive Summary, Vol. 2, Energy Security Report, Vol. 3, Environmental Health and Safety Report, Vol. 4, Economics Report, Vol. 5, Mandates and Incentives Report, San Francisco, Calif., June 13, 1990. 

International Programme on Chemieal Safety, Report of IPCS/OECD Scoping Meeting on Endocrine Disrnpters (EDCs), 16-18 March 1998, Washington, 1998. 

HSG 190 Preparing safety reports - Control of Major Accident Hazards Regulations 1999... 

Chemical sites and safety reports what you need to know (COMAHj Why do I need a safety data sheet ... 

Safety reports how HSE assesses them the Control of Industrial Major Accident Hazards Regulations 1984... 

Regulate the design and operation of defined major hazard installations. All necessary measures are required to prevent and limit the consequences of major accidents. Operators of upper-tier sites must produce a detailed Safety Report those of lower-tier sites must prepare a Major Accident Prevention Policy. 

Safety Report. Contract No. DE-AC02-94CE50389. Washington, DC United States Department ofEnergy. 

For new sites with 50 tons or more of LPG the Control of Major Accident Hazards Regulations 1984 apply. For sites which will have 300 tons or more (shortly to be reduced to 200 tons or more) these Regulations impose additional duties on site operators which include the prior submission of a safety report . This report has to set out the potential hazards of the plant and the means by which the risks are reduced to an acceptable level. The LPGITA has produced a Guide to the Writing of LPG Safety Reports which supplements the general guidance in the HSE booklet HS(R)21. 

Subchapter D - Information and Education Subchapter E - Environmental Impact Review Subchapter F - National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics Subchapter G - Safety Reports... 

E2B(R3) Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports... 

In addition to the expedited reporting described above, sponsors shall submit, once a year throughout the clinical trial, or on request, a safety report to the Competent Authority and the Ethics Committee. This should cover SUSARs, other serious adverse reactions, and an analysis of the subjects safety during the course of the trial. 

The sponsor is obliged to submit safety reports for SUSAR events to the same timelines as apply in Europe. They must also report within 15 days any findings from animal studies that would suggest an increased risk to human subjects, such as carcinogenidty or mutagenidty. 

Martin, Co. (anonym) Radioactive Materials Laboratory Safety Report, Martin Nuclear Facility, Quehanna Site. Report MND-2410 (Sept. I960). 

For these substances, the waste life stage of the substance needs to be covered by suitable exposure scenarios, the corresponding exposure estimation and the related risk characterisation. The conditions ensuring control of risk in the waste life stage of the substance need to be documented in the chemical safety report (CSR) and also communicated in the supply chain by means of the extended safety data sheet. [19]. 

Chemical safety report and/or safety data sheet. 

Rifaximin appeared to be effective and safe in both adults and children. Not only do these data support the efficacy of a nonabsorbable antibiotic in the treatment of diarrhea, the lack of absorption and degree of safety reported to date support the likelihood that rifaximin will be safe to use in pregnant women. Currently, the drugs of choice for the treatment of bacterial diarrhea, especially travelers diarrhea, are the fluoroquinolones, which are contraindicated in pregnancy. While rifaximin will likely never be adequately studied in pregnancy, it should be safe. 

The second step, of sorting the selected precursors according to their perceived safety related consequences, is achieved by studying safety reports and confronting the precursors with multi-disciplinary experts, i.e. experts from production, maintenance and safety. The expert group provided the identified precursors with perceived safety related consequences, by formulating possible scenario s, from which the consequences could be obtained. From both the likelihood (see Table 17) and perceived consequences, the perceived risk class is obtained, as discussed in Chapter 5. Figure 42 shows the risk matrix for the precursors presented in Table 17. 

A Chemical Safety Report (CSR) is required for substances registered at 10 tonnes per annum (i.e., with Annex VI data). The burden on industry has been eased in the final proposal (a. 12), because in earlier drafts, such as the consultation document (a. 11), a CSR would have been needed for all registered substances. 

CFR 312.32 Safety reports for investigational products subject to an IND application (published 1987). 

See also CFR Web site, http //www.access.gpo.gov/nara/cfr/index.html. An August 1997 guideline, Post-Marketing Adverse Experience Reporting for Human Drug and Licensed Biological Products Clarification of What to Report, defined the minimum data relevant for a safety report as... 

Reporting Forms. FDA form 3500/3500A (see Figure 20.1) is the standard form for notifying expedited reports and can also be used by companies to submit IND safety reports. Foreign cases may be reported on the CIOMS I form. 

Time Frames. The time period for submitting written IND safety reports has been revised from ten working days to 15 calendar days. For telephone reports (fatal and life-threatening unexpected reactions), it has been revised from three working days to seven calendar days. Such reports can also be made by fax. Telephone reporting was previously restricted to clinical studies conducted under the IND, but under the new rule, telephone reporting within seven calendar days applies to any unexpected fatal or life-threatening reaction from any source. 

Ioannides, J.P.A. and Lau, J. (2001). Completeness of safety reporting in randomized trials An evaluation of 7 medical areas. JAMA 24 437-443. 

The number on the outside of the case is required to be numeric or alphanumeric, not the name of the patient. Patient names are not permitted to be publicly disclosed in the context of a MedWatch report according to 21 CFR 21.63(f). The initial report is the first reported information received by the company about an individual s adverse drug experience. There must be a prompt attempt to obtain follow-up information about each initial report. The attempt(s) are made according to the company s written procedures. If the written safety procedures are not followed, the safety reports are not appropriately submitted, or the safety records are not appropriately kept, FDA has the authority under Section 80 of Part 315 to withdraw the market NDA. The follow-up report is the format for submitting additional information about an experience. Each case regards only one individual unless the experience is both temporally and clinically unrelated to a second event experienced by the same person taking the same drug product. 

ICH E2C and FDA March 2001 draft guidance Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines are available at www.fda.gov/cder/guidance/index.htm case requirements are accessible in 21 CFR 314.80. 

---