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regions to be taken into account. The intent must be to cover as much as possible with a shared core program and add studies for specific local requirements where unavoidable. |
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B.
Legal and Regulatory Requirements |
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The plan must also take into account government laws, guidelines, and points to consider of the regulatory authorities in the target countries as well as rules of ethical committees or IRBs. If clear guidelines do not exist, it is useful to obtain the advice of opinion leaders in the field, e.g., on choosing therapeutic targets and clinical endpoints. Furthermore, every opportunity to present the plan to a regulatory authority should be taken to obtain its opinion or consent. |
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III.
Preparing the Project Plan |
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A.
Elements of a Project Plan |
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The basic building block of any project plan is the single task leading to a defined result. This is commonly called a work package. The defined result, in most cases, is a study report required for IND or NDA submission. It may, however, also be a development or marketing plan or a produced and released batch of drug substance or formulation. For many work packages in drug development, the scope of study and content of the report are clearly defined by regulatory guidelines or by internal company standards. A list of all work packages and their definitions is an essential prerequisite for a standard plan. In addition, the department involved in carrying out the work should be specified. If several departments contribute to a single work package, the responsible department should be identified. There should also be a standard time estimate for executing the work package in the absence of resource constraints and abnormal technical problems. |
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Often, it is useful to break larger work packages down into smaller tasks, commonly called jobs. Again, each such job must have a defined end point. A simple example is a sequence such as a protocol design, treatment period, data, evaluation report in clinical or toxicological studies. Other job structures may be more complex, such as the many individual experimental studies comprising the technical or analytical IND or NDA documentation packages for a drug substance or a drug product. A list of jobs for each work package serves as a checklist and adds to the definition of the work package. |
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