Safety Assessment of Marketed

The need for monitoring long-term followup in post-marketing surveillance (PMS) and safety assessment of marketed medicines studies to determine effects of the drug on physical functions and development, such as bone maturation, growth and sexual development. 

Clause 10.2 Guidelines for Company Sponsored Safety Assessment of Marketed Medicines... 

Attention is drawn to the Guidelines for Company Sponsored Safety Assessment of Marketed Medicines (SAMM) which have been produced jointly by the ABPI, the British Medical Association, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency and the Royal College of General Practitioners. These state that SAMM studies should not be undertaken for the purposes of promotion. 

Ayres JG, Frost CD, Holmes WF, Williams DR, Ward SM. Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines BMJ 1998 317(7I63) 926-30. 

The main part of the safety assessment of finished products could be based, in principle, on data from the different ingredients used. The many thousands of different products on the market are all derived from a smaller number of ingredients. The toxicological profiles are also adequately studied... 

Metal foodstuff packaging continues to develop to make use of new materials, new technologies and new market opportunities. The safety assessment of new materials, technologies and applications will always be a fundamental part of any new development, indeed one of the drivers of new product development is to simplify and improve the safety assessment process without prejudicing the existing food safety attributes of the packaging. 

Assessment of market environrnorU including nonenergy sector and analysis, safety, and economics... 

The goal of safety assessment is to identify all failures that cause hazardous situations and to demonstrate that their probabilities are sufficiently low. In the application domains of safety-relevant software the safety assurance process is defined by the means of safety standards. The requirements of these standards must be met in order to enable argumentation that the system is safe. To reduce development costs and the time-to-market, one possible approach is to develop a safety assurance process which is applicable to multiple applications domains of embedded systems (e.g. like the lEC 61508 standard [3]). In this paper, we present an approach towards a safety assurance process for software which is applicable across different application domains of embedded systems. This process aims to be applicable with various development methodologies used in different domains and tries to use common safety analysis techniques as far as possible. Hence, it builds the foundation for the future development of methods and tools for safety assurance which can be applied across domains of safetyrelevant software systems. Thus, safety analysis techniques and tools as well as artifacts produced during the safety assurance process may be reused for the safety assessment of different kinds of products. Especially, in areas where embedded systems are highly related to software product-lines or heterogeneous... 

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