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Look around any organisation – large, medium and small. You have people, professional staff engaged in projects. These can incl

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

ude for example:

1.	service improvements
 2.	costs reduction
 3.      product development
 4.	staff development
 5. 	impr

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

Examples of combination products may in

ved sales

Where someone or a team are engaged in delivering a change, then you have a clear project and need to apply pr

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

oject management principles. But as we will show below, many people fail to recognise that the application to day-to-day work o

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

some of the tools within project management can help them enormously and answer a key question!

So, what is that questions? B

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

Combination pro

y far the most popular asked on any of our project management events is…..what is a project and what is not as project? There

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

re many book definitions which have failed to satisfy people on our courses. I am not of course criticising the project managem

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

ent definitions, simply saying that people who come our courses want much more clarity – what is and what is not a project?

T

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

ey want answers that will put work (project management work or non project management work) into neat boxes, project work here,

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

non project work there. However, work is not like this. So, how can we help them, and we hope you?

To answer this we have dev

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

loped a process called PROJECT BASED WORKING. The process is simple; we take some of the component parts of project management,

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

Following aspects would a

for example:

a)   developing a business case
 b)   having clear objectives for your project
 c)   carrying out risk asse

dd to the challenges in developing combination products:

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

sment d) managing stakeholders

We take the tools and processes within the above areas and apply to day to day work (bu

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

siness as usual). Here are some examples;

1)why do that report? (business case) ?
 2)are you clear what the objective is

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

ith that day to day task? 3)organising the meeting - what can go wrong (risk) ? 4)who do you need to involve to ensure a s

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

atisfactory delivery of the task; managing stakeholders

These are some simple examples of what we mean by project based

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

Professional from academic institutions, pharmaceutical industries, health care indust

orking -applying some of the tools of project management to day to day work.

So, why worry about what is and what is not a pro

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

ject? Use these tools on all types of work, everyday!

Many people who have come on project management events have argued over

.

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

his issue and it only when we explain about project based working they understand.

So the next time someone asks the questions

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

Companies that provide selfless information through particip

what is a project?, tell them about project based working. Explain what it is and how helps others and, how it can help them

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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