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Life at work can be fun, serious, harried, confusing, and rewarding. Sometimes it happens all in the same day. In a world where the only thing constant is change, here ar

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

e 10 things to learn, not only to survive, but to thrive!

1. Don't expect anything - like someone to always tell you what to do
Have you ever sat and

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

Examples of combination products may in

waited on others for direction. (They should be telling me what to do right?) If someone wanted to tell you what to do, trust me, they would have done it already. Be conf

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

dent and move forward.

2. If someone else is making a decision, let them own it Wishing you had the authority to decide something on another's plate won'

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

change their decision. It also doesn't do them any favours if you are trying to hold on to whatever they need to do. Allow them to do what they believe is right.

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

Combination pro

3. Fix what you can, don’t sweat what you can’t
If you have the ability to make something better at work, to clear up a misunderstanding, make a decision, o

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

r recommend a better process, then do it. If you don't have the ability to change it, simply let it be.

4. Everyone wants to do a good job
Really! Pe

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

ple don't set out to get it wrong, or miss the mark. They act on what they know, and what they actually heard of the directions.

5. Let your head drive busine

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

s, and your heart guide your head
Use your brains, it is what got you to the job you are in, but always pay attention to your gut, if something doesn't feel righ

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

, it is worth digging into, and if it feels good, go with it!

6. A lot of it is point of view
You may work hard producing something that only gets 5

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

minutes airtime at the meeting, but without that piece of information, the meeting may have revolved for hours around the lack of that knowledge. A certain piece of infor

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

Following aspects would a

mation means something different to different people in different areas of the organization, and most certainly to different levels of management.

7. Effectiv

dd to the challenges in developing combination products:

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

direction conveys the intent and allows the other to develop the content
Paint a clear picture of the desired result, the best end state (including anything you

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

don't want along the way), then give freedom and space which allows others to use their knowledge, skills and creativity to build something beyond your imagination. Of co

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

rse, if you know exactly what you want, and how you want it done, then just say that. There is a time and a place for each.

8. Don’t just react, write the e-

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

ail, walk away, then re-write it a couple of times without the negative emotion
Peel it back to facts and data, don't assume, and clarify information. Perpetuat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing negative emotions can make them grow exponentially. Make it your standard to always drop the bad feelings, and get on with business.

9. A leader stands in

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

their own space and allows other to do the same
Leaders understand their own ability to influence any situation they come into contact with, and they accept that

.

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

responsibility. They respect all others, acknowledging that we all have purpose in being here, and that no one of us is greater than another.

10. Don’t take

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

Companies that provide selfless information through particip

ork or yourself too seriously
There will be times when things go wrong, when work piles up or needs to be re-done, and stuff happens. So why not enjoy it anyways

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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