Reviews external expert

An application on the prescribed form is submitted to the Department of Drug Registration (DDR) of the State Food and Drug Administration (SFDA). The DDR evaluates the completeness of the document and then forwards it to the Center for Drug Evaluation (CDE) for technical review. External experts may be consulted, and the CDE compiles a technical report for the DDR. 

The management system for process definition documentation should ensure that the contents of the process documentation package are accurate and complete. A suitable review and quality assurance program should be implemented for the process documentation. This may involve a hierarchical review process, and/or using external experts in a review capacity. 

Review of the submission dossier will begin simultaneously with the above-mentioned com-pliancecheck. Reviewis undertaken by one of the four evaluation office teams, which comprised experts from medicine, pharmaceutical sciences, veterinary sciences and statistics. The team also includes external experts. Evaluation meetings are held at which questions are raised by the reviewing team and the applicant has the opportunity to discuss issues with the reviewers. The reviewer in charge will prepare a report of the application for the next stage of the special review and interview. 

NIOSH criteria documents are developed by NIOSH staff and reviewed by external expert consultants. 

To prepare successful CRFs, the sponsor s staff must know typical clinical practices, therapeutic conventions, investigator and staff needs, data management and analysis plans, project-specific definitions and procedures, CRF completion problem areas, remote data/electronic entry and review and approval procedures for CRFs. Ideally, CRFs should be pretested with internal and external experts (e.g. investigational sites). 

These identified AE-drug combinations are hypotheses for further testing follow-up may be necessary to determine whether they represent a potential drug safety issue. Further evaluation may include a query and review of the company s safety database, review of the scientific literature and preclinical data and consultation/discussion with internal and external experts. If a product safety issue was identified, next steps would include the development of a risk management and risk communication plan. 

Figure 19.2 Review process at Evaluation Centre. The new drug application dossier is reviewed at the Pharmaceutical and Medical Devices Evaluation Centre. The Centre organises a review team with scientific support from external experts. The applicant has two opportunities to meet the team during the review process.

Dependent on the size and the intended audience, different kinds of critical review are possible internal or external expert review and review by interested parties. 

Program reviews by external experts include regional and national accreditations, institutional reviews, and certification or approval ratings from engineering professional associations. For example, in Sweden, programs are reviewed by the Swedish National Agency for Higher Education. A description of a recent review is found in Box 9.3 in a later section of this chapter. 

Although the preparation of the written snbmission requires a lot of work and the visit is always looked forward to with some trepidation, most departments find that the accreditation process is very valnable. First, the need to review objectives, syllabuses and other aspects of the course at least every five years is a valuable discipline. Secondly, exposing even the best of courses to assessment by group of external experts will always produce valuable comments and suggestions. (Universities are nowadays required to have their own internal conrse review procedures but these procedures do not necessarily have substantial inpnt from external experts and, as a resnlt, may be concerned more with regulations than with content.)... 

The arguments from external experts were expounded during a debate that the students held with the engineer who authored the project, and the president of the environmentalist group Erva ( grass in Portuguese) who was the author of several pleas against the second layout. This debate took place after the sequence was completed and the reports written and reviewed, but before the examination paper and the final essay. 

EFSA was established in 2002 in response to several food crises of the 1990s (e.g., bovine spongiform encephalopathy—mad cow disease). It is intended as an independent source of scientific opinion in the area of food safety, and consults with the EC in its risk management decisions. EFSA works together with external experts who make up their thematically organized scientific panels. The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) reviews FCS applications and publishes publicly accessible scientific opinions on each substance. EFSA s scientific opinions are either based on requests by Member States, the EC, the E.U. Parliament, or are self-mandated. 

You should consider obtaining internal and external quality assurance reviews of the study (to ferret out errors in modeling, data, etc.). Independent peer reviews of the QRA results can be helpful by presenting alternate viewpoints, and you should include outside experts (either consultants or personnel from another plant) on the QRA review panel. You should also set up a mechanism wherein disputes between QRA team members (e.g., technical arguments about safety issues) can be voiced and reconciled. All of these factors play an essential role in producing a defendable, high-quality QRA. Once the QRA is complete, you must formally document your response to the project team s final report and any recommendations it contains. 

External review is of major importance in ensuring the outcome and reportability of LSMBS study results. Additional experts have the opportunity to review the data and results just after their generation, at a point where corrections can be easily proposed and made. In addition, external review aids in achieving consistency in the results reported by different laboratories. Finally, external review provides feedback for optimization of the analytical and instrumental parameters at each laboratory. 

The book is an important guide to scientists interested in environmental chemistry and engineering, and it represents an important addition to the scientific literature and a valuable source of reference for students, professors, scientists and engineers. The latest advances in physico-chemical methods and techniques to study various aspects of natural nonliving organic matter are also reviewed critically and addressed clearly. The chapter authors are scientists who are internationally renowned experts in their fields, and all the chapters have been reviewed by at least two external referees. 

Unlike public review, which are almost exclusively for final drafts, private reviews cover several drafts of a single standard, drawing inputs to help its refinement through most of the process. There is a reluctance in everyone, not just developers, to hold up their early attempts, their unfinished work, to public scrutiny. That makes private reviews of early draft more valuable than public reviews. At each major revision of the standard, in many SDO s, the draft is distribution to the members for review and comment. For example, within ISO, each Committee Draft, CD, is sent to each national body for review, for comment, and for ballot. Liaisons and other interested reviewers, experts in some aspect of the standard, are also asked to participate in the review. The end result is that more aspects of the standard are considered throughout the development process. In addition, those external reviewers have a say and therefore a stake in the resultant standard. 

REPROTEXT summaries are written by an expert reproductive and developmental toxicologist. There is no formal external peer review of the summaries. 

The above-described procedures are very sensitive to external conditions. The application of the same methods at various laboratories often leads to conflicting results. A study of the original literature is therefore necessary for the specialist. Fortunately a number of expert review articles have been recently published [119, 144-146]. 

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