Action Area

PC Tox PC Pkin Formul QA Stabil Manuf Clin Manuf Scale IND Prep & FDA 1st Phase 1 1st Phase 2 1st Phase 3 Pkg Engin NDA Approval Mkt Assess Bus plan Patent

' 2Q'7 3Q'7 4Q'7 1Q'8 2Q'8 3Q'8

• Deadlines

Timeline: Start

=0 End

Ind Drug Project Management

Fig. 2.42. Product Project Management (Gantt Style Chart)

r Identify all risks (take the time) r Prioritize project work

Analyze both probabilities & r Supports decision making &

impacts of risks planning

Prioritize risks on drug r Avoids crisis management development, esp. timeline

r Plan responses to risks r Encourages management of

(avoid, mitigate, accept) opportunities r Monitor for risk occurrence & k Creates project credibility for

Implement responses milestones and time lines

► Repeat cycle as a risk occur ► Provide more realistic control of project outcomes

Fig. 2.43. Project Risk Management change processes to rectify the delays. Also, areas of the company consistently exceeding deadlines can be identified for awards of excellence [41, 42].

Risk management (RM) for projects is a permutation of project management wherein the PM manager and team members try to anticipate future problems and mitigate them in advance (Fig. 2.43). The axiom, "an ounce of prevention is worth a pound of work or problems," is an excellent justification for RM. Although extra team member time is taken up-front delaying some work, the total time for the projects is lessened along with less anxiety, more timely execution, better team morale, and product success. Some areas of the company may be known for delays; which is where RM should be done. For high-priority products that are on a fast track, you want no down time or delays, because of the high corporate profile and the greatest need for optimal follow-through. Here especially is where RM will serve an organization well. Crisis management is needed in all companies but creates major delays with low morale and higher costs when one project has to be redone, upsetting sequence of work in other areas as well. Avoidance actually will take less time, benefit the company by avoiding angst, and offer more productivity in R&D and more commercial success as well. Also, RM helps an organization learn from its mistakes or problems, which is a strong learning tool for process improvement and efficiency. A full discussion of RM is not possible here, but a summary is provided in Figure 2.43 to offer at least an overview of this important process.

One way to enhance performance is to do a postmortem examination of a program to determine what went well and where there were problems. if the data from this sort of evaluation can be collected in a systematic way and reviewed honestly and openly with senior management, problem areas can be identified. Solutions found in one project may be utilized in others to improve the development process. PPM can collect this data and is in a good position to share the learnings with new teams early as a preventative and educational measure to avoid pitfalls.

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Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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