Committees as authors

All CTs (phase IV ones included) need ethical approval by independent central or regional ethics committees, as specified by a Decree of the Minister of Health in 1987, to be issued in an amended form in 1999. Phase I-III trials also need authorization by the competent medicine regulatory authority (the NIP or the Executive Office of the National Chief Medical Officer). The documentation needed for authorization does not differ from that in the EU. In short, it consists of the following (if not specified, it may be in English German may also be accepted) ... 

Standard nomenclature rules are of limited value if many chemists are not familiar with them. As chairman of the ACS committee the author endeavors to place special emphasis on the wide distribution of nomenclature information. In addition to the writing of numerous letters thousands of copies of the following nomenclature pamphlets have been distributed ... 

The Council, acting through the Committee on National Policy of the American Chemical Society, appointed the editors, named at the close of this introduction, to have charge of securing author s, and of considering critically the manuscripts prepared. The editors of each series will endeavor to select topics which are of current interest and authors who are recognized as authorities in their respective fields. The list of monographs thus far secured appears in the publisher s own announcement elsewhere in this volume. 

Some cynics, particularly in academia, maintain that the last thing ever successfully accomplished by committee was the King James version of the Bible. In a sense, this text has also been composed by a committee. As editors, we have tried to keep the depth of presentation more or less even, consistent with our feelings as to the importance of a particular method for quantitative applications and to provide the continuity of thought and mode of expression so important in a text. We happily allot to the authors whatever credit may accrue for the quality of the individual parts and, as editors, assume responsibility for the shortcomings of the whole. 

The hazard resolution process is a critical component of the SMS. If employees and OSHA (or other regulatory) inspectors are to feel secure that the firm is following a sane safety program, it is important to explain how hazards are resolved. How are hazards controlled Who has signature authority verifying that the hazard is controlled adequately Many corporations use the system safety committee as a controlling body. 

The editors thank the Monterey organizing committee as well as the authors and participants for making the 5th International Symposium a success. The organizing committee, cochaired by Tom Chapin (UL), Anastasia Muhana (Texas A M), Valeria La Saponara (University of California Davis), and Chris White (NIST) included ... 

Lubricants since 1976. He has served as author of numerous methods and practices, editor, subcommittee chairman, first vice-chairman of Committee D02 and as a member of the Committee on Standards. Drews has been honored with numerous ASTM awards including the Committee D02 Scroll of Achievement, the Award of Excellence, Honorary D02 Membership, the Lowrie B. Sargent, Jr. Medal, and the ASTM Award of Merit. 

At the European level, the national organizations from both the EU (European Union, formerly the EEC) and the EETA (European Free Trade Association) are grouped in the CEN (European Committee for Standardization) and its counterpart for the electrical industries CENELEC. The standards published by these two organizations have authority in all EU countries as well as the EFTA countries who have voted their approval, which means that these standards have replaced their corresponding national standards. 

This book is written as the book one wants to read when first starting the study of filtration. This book is intended for the person who has some technical background outside of filtration, and who now wants to "get his feet wet" in this subject This book is also for the "old filtration hand" who, while he has some experience in some special field of filtration, may now want to step back and see a larger view. And it is intended as a vehicle for sorting out and explaining words and phrases that appear in technical and advertising literature. The incentive to write this book comes from the author s experience, as a charter member of ASTM s Committee F21 on Filtration, as chair of the subcommittee on liquid filtration (for 15 years), and as an instigator of the 1986 symposium on filtration sponsored by ASTM. 

Terms of reference are not job descriptions but descriptions of the boundary conditions. They act as statements that can be referred to in deciding the direction in which one should be going and the constraints on how to get there. They are more like rules than a job description and more suited to a committee than an individual. They rarely cover responsibilities and authority except by default. 

In his scientific life, his behavior and demeanor were far different. Newton was hostile to any criticism and he was capable of ruthless behavior. The priority dispute with the German mathematician Gottfried Wilhelm Leibniz over the invention of the calculus is a case in point. In his capacity as President of the Royal Society, Newton appointed a committee of loyal Newtonians to investigate the matter. He then authored the committee s report, the infamous Comrnercium Epistolicmn and submitted it as though it were an utterly impartial report in his own favor. 

The authority granting permission to build will depend upon the type and size of building. Major projects, such as nuclear power stations or large industrial complexes, may involve a public enquiry and the need to produce a study into the environmental impact. Though a committee nominated by the local authority will consider the planning submission. 

This consists of a chairman appointed by the Secretary of State for Employment and a committee of not less than six and not more than nine members. The composition of the Commission is drawn from different groups three members may be from employers organizations and three from employees organizations. The three remaining vacancies may be filled from such organizations as local authorities and professional bodies, as the Secretary of State considers appropriate. 

Applications to the Ethics Committee should be made using the same application form as used for the Competent Authority. Most of the data submitted to the Competent Authority will also need to be included in the application to the Ethics Committee, although the IMPD is usually not required. Similar to the Competent Authority, the Ethics Committee is allowed 60 days to deliver an opinion (90 days for advanced therapy products), having given particular attention to the following ... 

During the course of its conduct, the sponsor may need to amend a clinical trial, as a consequence of the emergence of new information. If the amendments are deemed to be substantial, in that they may impact on the safety of trial subjects, or change the interpretation of the scientific documents in support of the conduct of the trial, or are otherwise significant, the sponsor shall notify the Competent Authority and the Ethics Committee, using a Trial Amendment Form. The Ethics Committee are permitted 35 days to approve the amendment. 

If the events are classified as Suspected Unexpected Serious Adverse Reactions (SUSARs) that are fatal or life-threatening, the sponsor must then report them to the Ethics Committee and the Competent Authority within 7 days. Other SUSARs must be reported within 15 days. The sponsor must also inform all other investigators involved in the trial. The Competent Authority is required to enter the information... 

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