|
|
|
|
|
|
|
There is considerable flexibility in defining larger or smaller work packages and jobs within these definitions. Two general rules may be useful for practical planning: |
|
|
|
|
|
|
|
|
1. Work packages should, preferably, be carried out within a single department. |
|
|
|
|
|
|
|
|
2. Work packages identify the detail level of planning and time tracking by the project manager, whereas jobs are tracked within the departments responsible for the work package. |
|
|
|
|
|
|
|
|
Using these definitions, the size of work packages may vary in different companies depending on the agreed distribution of project tracking responsibility between project management and line functions. Nevertheless, some common practices have evolved and a typical project plan contains between 200 and 300 work packages. |
|
|
|
|
|
|
|
|
For upper management presentation and review, a plan containing all work packages is much too detailed and needs focusing by aggregation. A first level of aggregation may be the combination of individual studies in one discipline into a super work package for each phase, such as all toxicological or animal pharmacokinetic studies in preclinical, the basic clinical phase I program, or all clinical studies in phases II and III. The most condensed plan for practical use is obtained by aggregating all activities into the standard development phases. An example of the different detail levels of planning is given in Fig. 2. |
|
|
|
|
|
|
|
|
The project plan should also be structured by using defined decision points and milestones. Decision points indicate the requirement of a management decision for continuation of the project. The decision is typically based on an evaluation of completed studies, a commercial evaluation of the project, and a plan covering at least the next project phase. The scope and level of detail of these decision prerequisites must be carefully defined. Milestones are easily measurable time points of project progress. They serve for planning and comparison of progress to plan. A set of practical milestones and decision points is given in Table 3. |
|
|
|
|
|
|
|
|
Generally, conceptual planning should be done from the end to the beginning, starting with the outline of the pivotal clinical trials necessary for approval and, then, adding the nonclinical, clinical dose-finding and clinical pharmacology studies prerequisite to enter the large and final studies. The initial preclinical development phase, however, typically follows a fairly |
|
|
|
|
|