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In recent years, many companies are putting increased emphasis on project management techniques as a result of lessons learned on past project performance. After experiencing project delays, overruns, missed quality goals, communication barriers, “scope creep”, and a general perception of projects being out of control, these companies are sc

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

rambling to implement good Project Management practices to prevent these types of problems. As part of these best practices, many companies have established project review and audit programs, periodically reviewing the status of projects and their alignment with individual and corporate goals. While worthwhile, in many cases these reviews a

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

d audits are performed by senior managers with either a stake in the project outcome or no real experience and training in project management. Several companies have found that these management reviews have not succeeded because senior management and project managers may be speaking a different language and viewing the projects from complete

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ly different perspectives.

Audits and reviews require preparation to be fruitful. Pre-defined project review and audit protocols can help focus both the project manager and the reviewer/auditor on the important aspects of the project. Basing these protocols on proven philosophies from the Project Management Institute (PMI®), the world’s fo

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

emost authority for the project management profession, can provide great insight into the actual status of the project. This provides the opportunity to take actions at the most efficient points in project execution, increasing the probability of project success.

We’ve found that the most effective audits are centered on the project managem

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ent knowledge areas as defined by PMI®. We have also found that effective project reviews and audits involve much more than just sitting down with the project manager and asking a series of questions. Interviews with project team members, stakeholders, and senior management as well as a thorough review of all project related documentation ar

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

just as critical to producing effective results.

Compliance with Project Management Processes

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

lity of project success. Audits should closely examine compliance of the project procedures with the enterprise’s Project Management Processes. Blind adherence to these procedures, however, without allowance for the specifics of the project, may introduce inefficiencies and stifle the creativity or flexibility needed to bring a project to a

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

uccessful conclusion.

Controlling Scope

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

tems to the project, and limit scope creep. Audits should target Scope Management as a major factor in overall project performance in order to prevent unnecessarily increasing the project’s size without correspondingly increasing the project’s value.

Compliance with the Project Charter

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

d terms the project targets and how project success will be measured. It essentially serves as the prime focus of all project efforts. Projects can easily get off track by ignoring the project charter, resulting in both schedule and budget problems.

Cost

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ating and tracking of budgets is essential to controlling costs on a project. Understanding the budgetary state of a project can impact all decisions made during project execution and design. Audits should focus on the two most critical aspects of cost control – estimating and tracking. Estimating factors include the methodologies used to de

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

termine project costs and cost constraints, resource planning and assumptions made during the estimating process. Tracking factors include the mechanism used to track costs and methodologies used in determining project cost status.

Time

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ng time-to-market goals. Carefully defining project activities, sequencing them properly, estimating resources and time for each, and developing the schedule are all critical phases of the planning process. Audits and reviews should focus on compliance with time management processes– Were activities defined and sequenced properly? How were e

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

stimates determined? And what mechanisms are being used to monitor adherence and control the schedule?

Communication

communication is the Number 1 problem encountered by project managers

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

With this level of importance, audits and reviews should focus heavily on the Project Manager’s communications procedures and capabilities, overcoming barriers to communications within the company, and the efficiency of mechanisms used for communications – Are stakeholders being kept appraised of the information they need to know for the pro

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ject to be successful?

Risk

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

problems and planning responses to problems that can not be prevented.

Quality

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

r inspected in? Are all members of the team (including management) participants in the quality process?

Human Resources

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

of management, team members and other stakeholders on the project is essential. Project audits should focus on the critical aspects of HR management – Is the project properly staffed? Are the team members meshing so the whole is greater than the sum of the parts? Are the roles of the members understood? Are there motivational problems?

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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