Advice Pool - Business

Accurate time estimation is a skill essential for good project management. It is important to get time estimates right for two main reasons:

1. Time estimates drive the setting of deadli

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

nes for delivery and planning of projects, and hence will impact on other peoples assessment of your reliability and competence as a project manager.
2. Time estimates often determine

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

Examples of combination products may in

the pricing of contracts and hence the profitability of the contract /project in commercial terms.

Often people underestimate the amount of time needed to implement projects. This is tru

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

particularly when the project manager is not familiar with the task to be carried out. Unexpected events or unscheduled high priority work may not be taken into account.

Project manager

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

s also often simply fail to allow for the full complexity or potential errors and stuff ups, involved with a project. The 2004-2006 Wembley Stadium project in London is often used as an e

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

Combination pro

ample, although there are countless others of less profile.

Time estimates are important as inputs into other techniques used to organise and structure all projects. Using good time esti

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

ation techniques may reduce large projects to a series of smaller projects.

Step 1 - Understand the Project Outcome
First you need to fully understand what it is yo

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

u need to achieve. (Refer to my article; Project Management - Begin with the end in mind). Review the project /task in detail so that there are no ‘unknowns’. Some difficult-to-understan

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

, tricky problems that take the greatest amount of time to solve. The best way to review the job is to just list all component tasks in full detail.

Step 2 - Estimate time
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
>
When you have a detailed list of all the tasks that you must achieve to complete the project then you can begin to estimate how long each will take.

Make sure that you also allow t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
me for project management administration, detailed project, liaison with outside bodies’ resources and authorities, meetings, quality assurance developing supporting documentation or proce
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
dures necessary, and training.

Also make sure that you have allowed time for:
• Other high urgency tasks to be carried out which will have priority over this one
• Accidents and
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
emergencies
• Internal/external meetings
• Holidays and sickness in key staff/stakeholders
• Contact with other customers, suppliers and contractors.
• Breakdowns in e
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
uipment
• Missed deliveries by suppliers
• Interruptions by customers, suppliers, contractors, family, pets, co- workers etc
• Others priorities and schedules e.g. local gov
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ernment planning processes
• Quality control rejections etc.
• Unanticipated events (e.g. renovating the bathroom finding white-ants/termites in the walls)

These factors may
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
significantly lengthen the time and cost needed to complete a project.

If the accuracy of time estimates is critical, you will find it effective to develop a systematic approach to includ
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ng these factors. If possible, base this on past experience. In the absence of your own past experience, ask someone who has already done the task or project to advise what can go wrong;
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
what you need to plan for; and how long each task took previously.

You can lose a great deal of credibility, and money, by underestimating the length of time needed to implement a project
.

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
If you underestimate time, not only do you miss deadlines, you can also put other people under unnecessary stress.

Step 3 – Plan for it Going Wrong
Finally, allow
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ime for all the expected and unexpected disruptions and delays to work that will inevitably happen. Sickness, strikes, materials not available, poor quality work, bureaucratic bungling etc

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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Advice Pool - Project Management - Time Estimates and Planning

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