Steering committees, activities

The Center for Chemical Process Safety (CCPS), a directorate of AIChE, was established in 1985 to develop and disseminate technical information for use in the prevention of major chemical accidents. The CCPS is supported by a diverse group of industrial sponsors in the chemical process industry and related industries who provide the necessary funding and professional guidance for its projects. The CCPS Technical Steering Committee and the technical subcommittees oversee individual projects selected by CCPS. Professional representatives of the sponsoring companies staff the subcommittees, with a member of the CCPS staff coordinating the activities of the sub-committee. 

Harmonisation activities are overseen by a steering committee comprising representatives of each of the six parties, together with observers from the WHO, the European Eree Trade Association (EFTA) and Canada. The Committee meet at least twice each year, with the location rotating between the three regions. The committee also organises major international conferences on harmonisation that are held every 2 years. 

If you did not already foimd your implementation team prior to designing the implementation proposal, you should certainly do it now. In the previous chapter, we agreed to use the term implementation team to refer to those people who are actively involved in implementing the scheme. In contrast to that, the steering committee is the implementation team plus the scheme s (financial) sponsors, who, although involved with the... 

Stages in hazard characterization according to the European Commission s Scientific Steering Committee are (1) establishment of the dose-response relationship for each critical effect (2) identification of the most sensitive species and strain (3) characterization of the mode of action and mechanisms of critical effects (including the possible roles of active metabolites) (4) high to low dose (exposure) extrapolation and interspecies extrapolation and (5) evaluation of factors that can influence severity and duration of adverse health effects. 

In several studies of toxicity, no adverse effects were documented in monkeys or humans. Taking into account data showing that lutein was not genotoxic, had no structural alert, did not exhibit tumor-promoting activity, and is a natural component of the body (the eye), the Scientific Steering Committee concluded there was no need for a study of carcinogenicity. 

The organization of PQRI is shown in Figure 5. A board of directors collects and allocates funds. A steering committee directs overall activities, and a series of technical committees work in five current priority areas drug substance, drug product, biopharmaceutics, science management, and novel... 

Professor Crowl has an active research program on flammability and reactivity and has published numerous papers in these areas. He serves on several AICHE/CCPS committees, including the Undergraduate Education Committee, the Technical Steering Committee, the Inherent Safety Committee, and the Risk Assessment Committee. He is also a member of the advisory committee for the Institute for Safety Through Design of the National Safety Council. 

The current structure of MedDRA is defined in Table 21.6. There will be a central maintenance organization responsible for development, user support, implementation and communication as well as an international user group. A management board will oversee the activities of the central maintenance organization with direction provided by the ICH Steering Committee. A standard medical dictionary will facilitate electronic data exchange between industry and regulatory authorities worldwide, as recommended by the ICH. 

The ICH Steering Committee responded favorably to a request by USP for observer status, recognizing it as a nongovernment, nonindustry body with official status under U.S. statutes. Now each of the three pharmacopeias can participate in EWG-Q activities and in ICH biennial meetings as independent bodies. 

The Board has noted that, in each of the above-mentioned cases involving stopped shipments, brokers had placed the orders. While the activities of brokers have been closely examined under Operation Purple, their activities have not been scrutinized under Operation Topaz. The Board therefore requests the Steering Committee of Operation Topaz to work with participating countries to make a comprehensive evaluation of the role brokers are playing in the diversion and subsequent smuggling of acetic anhydride. 

A detailed description of how Operation Purple developed, its activities and the results achieved in phase I are presented in the 1999 report of the Board on the implementation of article 12 of the 1988 Convention (United Nations publication. Sales No. E.00.XI.3). The activities undertaken during the initial stages of phase II are presented in the 2000 report of the Board on the implementation of article 12 (United Nations publication. Sales No. E.01.X1.4). The objectives of the operation, the procedural details and its results can further be found in the report on phase I of the operation prepared by the Steering Committee. 

Process improvements may be conducted by the completion of a task or a project. A task is an activity that can be completed by the process owner with minimal cost and/or resources over a short period of time. A project is defined as temporary work to provide a product or service that is beyond the process owner s support. In general, a project requires more than one full-time equivalent (FTE), crosses over multiple functional organizations, and the duration of the effort spans over a longer period of time. Improvement status, updates, and issues should be discussed on a regular basis by a management forum or steering committee. Tasks and projects should be prioritized based on the risk against patient safety and efficacy and compliance. 

In addition to the active sponsors, WHO, EFTA, and Canada are taking part as observers. The IFPMA (International Federation of Pharmaceutical Manufacturers Association) runs the ICH secretariat and sits on the steering committee. 

Myres, G. J., The Art of Software Testing, New York Wiley, 1979 ICH. Harmonized tripartite guideline. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. ICH Steering Committee. Nov. 10,2000. 

This interest led to the CCPS Technical Steering Committee authorizing the creation of a project committee to develop a book of guidelines for the development and use of leading and lagging process safety metrics. To achieve broader industry acceptance, CCPS invited representatives from many chemical and petroleum companies, trade associations, labor groups, regulators, and academics involved in the field of process safety, as well as other key stakeholders or subject mater experts to participate in this committee s activities. 

Prof. Heublein held the chair of Organic Chemistry from 1968. He was author or co-author of more than 300 scientific papers, of 4 books, and held more than 70 patents. He worked actively on many scientific commissions and was member of the International Steering Committee of the International Symposium on Cationic Polymerisation, the 7th of which took place with great success in Jena in 1985. From 1981 he was on the editorial board of the J. Macromol. Sci.-Chem. and, from 1983, one of the editors of Advances in Polymer Science. 

Administration ICH is administered by the ICH Steering Committee, which is supported by the ICH Secretariat. Each of the six sponsors has had two seats on the ICH Steering Committee (SQ, which oversees the harmonization activities. 

It is critical that key senior officials actively participate on the steering committee and perhaps in the audit process itself. This will help ensure their buy-in of the process and motivate them to implement the resulting recommendations. Involving external stakeholders assures an increased level of objectivity in the process and can begin to build mutually beneficial relationships where they did not exist. 

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