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Gantt charts are useful tools for analysing, planning and controlling complex multi stage projects.

Gantt Charts can;
Assist in identifying the tasks and sub tasks to be undertaken
Help you lay

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

out the tasks that need to be completed
Assist in scheduling when these tasks will be carried out and in what order
Assist in planning resources and needed to complete the project,
Assist

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

Examples of combination products may in

in working out the critical path for a project where it needs to be completed by a particular date.

When a complex or multi task project is under way, Gantt charts assist in monitoring whether the projec

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

is on schedule, or not. If not, the Gantt chart allows you to easily identify what actions need to be taken in order to put the project back onto schedule.

An essential concept behind project planning

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

is that some activities depend upon other activities being completed first. For example, it is not a good idea to start building the walls in an office block before you have laid the foundations; neither

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

Combination pro

is it a good idea to put the cake mix into the tin without greasing the tin first.

These are dependent activities which need to be completed in a sequence, with each stage being more-or-less completed be

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

ore the next stage can begin. We can call such dependent activities ‘sequential’.

Non sequential activities are not dependent on the completion of any other tasks. These activities may be done at any t

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

ime before or after a particular stage in the project is reached. These activities are called are nondependent or ‘parallel’ tasks.

To create a Gantt chart;

1. List all activities/tasks in the plan

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

For each task, show the earliest possible start date, how long you estimate the length of time it should take, and whether it is parallel or sequential. If tasks are sequential, show which stages they

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

depend on.

Head up a sheet of graph paper (using pencil and a ruler) with the days, weeks or months through to task completion on the top X-axis. The y-Axis can be used to itemise each task in its orde

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

. You may want to use an Excel Spreadsheet for this instead of graph paper if you prefer.

2. Plot the tasks onto the Plan
Next list the tasks in the first column on the left hand side of the page. (

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

Following aspects would a

The Y-Axis) To draw up a rough first draft of the Gantt chart; Plot each task on the plan, showing it starting on the earliest possible date. Draw each task as a horizontal bar, with the length of the ba

dd to the challenges in developing combination products:

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

being the length of time you estimate the task will take. Above each task bar, mark the estimated time taken to complete the task. At this stage there is no need to include scheduling - all you are doi

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

g is setting up the first draft.

3 Schedule the tasks/activities
Now on a fresh sheet redraw the Gantt Chart to schedule actions and tasks. Schedule these in such a way that sequential actions are

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

carried out in the desired sequence (e.g. dig holes, lay foundations, begin construction). Ensure that these dependent activities do not start until the activities they depend on have been fully comple

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

ed.

Where possible, schedule parallel tasks so that they do not interfere with sequential actions on the critical path. While scheduling, ensure that you make best use of the time and resources you have

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

Professional from academic institutions, pharmaceutical industries, health care indust

vailable. Do not over-commit resources and allow some time in the schedule for holdups, overruns, quality rejections, failures in delivery, etc.

Once the Gantt chart is drawn, you can see how long will i

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

t take to complete your project. The key steps to be completed to ensure successful completion of the project should be clearly visible.

In practice professional Project Managers use sophisticated softw

.

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

re like MS Project to create Gantt charts. Not only do these packages make the drawing of Gantt charts easier, they also make subsequent modification of plans easier and provide facilities for monitoring

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

Companies that provide selfless information through particip

progress against plans. Tables and spreadsheets can also be used to create simple and easy to change charts without MS Project. Spreadsheets with coloured bars are most useful for the simplest projects

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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