Budget development/execution

A sponsor of a medical product entering the development phase must have a clinical development plan, which is created by experienced executives and consultants having expertise and experience in the disease state for which the product is intended. Once the plan is created, with appropriate input from regulators, the plan drives a clinical development budget, with consideration of the desired timeframe for projected producf approval. After the plan is created, the management team determines the "make vs. buy" strategy, which determines the elements of fhe plan that will be outsourced. 

Overhead is nonproductive time spent on tasks that do not support execution of the project workplan or production of the deliverables but ctm have considerable impact on the project schedule, the resource loading, and potentially the budget. Overhead could include travel time, holidays, vacation, professional development, or personal/sick time. 

Where it is required that an attempt be made to implement new technology and where a determination must be made as to whether certain equipment can perform a desired function, it will be necessary to conduct a feasibility study. The systems engineer may be called upon to assess the state-of-the-art to develop a new application. An executive summary or a more detailed report of evaluation test results may be required, in addition to a budget request, to help management make a decision. 

To facilitate decisions on the various outstanding questions pertaining to the costs of verification, the Technical Secretariat shall document by category and Member State all costs incurred related to inspections under Articles IV and V. For transparency purposes an initial report on this documentation will be made available to all Member States when the draft 1998 budget is taken up by the Executive Council. These records will be used to reconcile the final 1997 budget and to develop the 1998 budget once the issues concerning cost attribution are resolved... 

In conformity with principles laid down by the Conference of the States Parties, with due regard to the Programme of Work and Budget and the OPCW Financial Regulations and Rules, and taking into consideration the master standards of job classification as developed by the International Civil Service Commission (hereinafter the ICSC ), the Director-General shall prepare and submit to the Executive Council for its consideration and approval, proposals for the classification of posts according to the nature of the duties and responsibilities required. 

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