Cases - Business

One of the certain aspects of working life is that unexpectedly you can be assigned a project to do. In fact if you are building a business of your own you will have long-term projects that are essential to its profitable developm

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

ent.

But in order to ensure the smooth and successful running of your business it's vital to have efficient systems in place to deal with these projects. Most of them will have deadlines for completion at some point in the future

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

Examples of combination products may in

. But it is how you deal with these deadlines that will determine how efficient you are at managing your business.

The simple thing to do is to schedule the project in your diary for perhaps a few days before the completion date,

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

even if it is several weeks away. This is a big mistake!

In order to effectively control your time you should be in the habit of using lists to plan your working days. Each day you should have a daily task list of the things tha

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

t must be done. Anything new that comes in during the day should normally be put onto your list for the following day. Only the genuine things that can't wait until tomorrow should be added to the list to do the same day.

So as s

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

Combination pro

oon as you are given a project to deal with you must put an item to start it on your must do list for the next day. That item will be to simply write a checklist for the project. You must do this or else you will find that as the

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

deadline approaches you have to put off other important tasks in order to get the project completed. Then all of the good habits you have developed in using lists to manage your time will be to no avail.

So when the next day arri

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

ves one of your must do tasks will be to write your project checklist. This must contain dates for completing each part of your project. The plan should be to finish it well before the deadline so that you can allocate time if nee

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

d be for any last minute revisions.

Break the project down into smaller parts and set dates in your diary for doing each of them. Each one should go into your diary the day before you are going to do it so that you can include th

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

e task on your daily task list for the following day. That way you are still going to retain effective control over how you use your time and keep in place an efficient management system. You should also be sure to include dates f

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

or regular checks on progress and make any adjustments as necessary. That way you will remain in control of the time-frame for the project.

In effectively managing any project there a number of key elements that must be included.

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

Following aspects would a

The following gives a summary of what they are:

• Define the task – It is essential that you write clearly what has to be done and what the end result must be.

• Make a plan – Decide step by step what needs to be done and break

dd to the challenges in developing combination products:

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

it down into smaller parts. Then schedule dates for the completion of the individual tasks that will make up the whole project.

• Allocate work and resources - Ensure that you know what has to be done at each stage, what resourc

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

es you will need , and whether other people are to be involved in doing some of the work. If you are to delegate any of the work it is important that you give the other people involved sufficient time to complete it. They will nee

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

d to be able to manage their part of the project in exactly the same way that you are, so be sure to give them clear instructions and with enough advance notice. Also ensure that the time-scales for their work are in line with the

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

other project tasks. You want to make sure that you are not waiting for completed work by someone else at the point when you need to move onto the next part of your plan.

• Put in place controls to ensure the pace of the work an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d its quality. You must set standards which must be adhered to and so you must have a way of monitoring them.

• Regularly check performance against the plan - It is essential that part of the process is to have regular reviews of

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

progress measured against the plan. Where others are working on specific tasks it is vital to give them feedback on their contribution.

• Adjust the plan as necessary to ensure completion – By setting a completion date ahead of

.

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

the actual deadline you should always have the time and flexibility to make any adjustments that become necessary and still get the project completed on time.

Work in this way and all of your projects will get completed in an eff

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

Companies that provide selfless information through particip

icient manner and will slot in smoothly with your existing effective management systems. You will keep control of all the work that you have to do and so ensure that your business remains on track to making the profits you desire.

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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