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One of the tasks that come with being a leader is setting goals. Goals for ourselves, to be sure, but often we need set goals for our groups/teams or the larger organization. Wh

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

ile we may instinctively know that we should include people in the creation of goals they will be working to achieve, too often the press of time and the lure of expediency leaves

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

Examples of combination products may in

leaders setting the goals, and simply sharing them with those charged with achieving them.

The Four Reasons

There are four significant reasons why we need to get others

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

involved in creating of the group’s goals. Any one of these are reason enough to create a conversation about the goals rather than creating a PowerPoint presentation with the goa

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

ls already formulated.

• To gain Agreement. There are actually two agreements you want to gain.

1. Agreement on what the goal actually is.

2. Agreement that the goal is

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

Combination pro

worthwhile and beneficial.

Once you have these agreements you will increase the clarity of the goal for everyone. Goal clarity in itself has a very positive impact on ultimate

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

goal achievement. With agreement you will increase focus on the goal as well. Take the time to create both of these agreements and you have a stronger chance of achieving the ne

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

t item . . .

• To create Engagement. Notice I said engagement not buy-in. I know we all talk about wanting people to “buy-in” to our ideas and plans. And, given the cho

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

ice between having people who are “bought-in” vs. people who didn’t care or disagree, I choose the former. But engagement is more than “buy-in.” When people are engaged in an id

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

ea they are committed to it. They feel ownership for it. They have thrown more than their hat into the ring, they have thrown their heart in too. Once people are engaged in the

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

goal you can capture what comes next . . .

• To set Collective Consciousness. Have you ever noticed that after you buy a new car, you see “your” car everywhere? The rea

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

Following aspects would a

son this occurs isn’t because thousands of people followed your lead to buy the same car you did. It happens because of your Reticular Activating System. Our Reticular Activatin

dd to the challenges in developing combination products:

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

g System works as a filter helps us notice things we are focusing on or are interested in. Once people are fully engaged in a goal their subconscious mind goes to work and the Re

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

ticular Activating System helps. People will begin to see things that will be resources, methods or clues to achieving the goal. Sparks will fly between people on the team and p

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

ogress may be achieved faster than could be logically expected.

• To manifest Synergy. We have people work together because we know that together we can achieve more than

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

we can separately. This is the definition of synergy. If you prepare your goals in a vacuum and present them to the group the chance for you to achieve team synergies is virtua

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

Professional from academic institutions, pharmaceutical industries, health care indust

lly nil. The whole point of a group working towards a goal together is to gain synergy. If you want it, you have to let people help create the specific goals they will be direct

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

ly involved in achieving.

Getting others involved in the creation of the goals is more than just a good idea. It is more than just the right thing to do. It is the most importa

.

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

nt step you can take to improve the likelihood that a goal that is set, is reached.

So when you have a goal to be achieved with the help of others, keep these four reasons in min

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

Companies that provide selfless information through particip

d and make the time to create the massive benefits described here.

That time and effort is the best insurance policy you can buy to improve the chance your goals will be achieved

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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My starting point was how to draw on 25 years of experience in which I have helped thousands of people to their own career success, and make this knowledge freely available to anyone and everyone who could use it. I believe that if people are given the right information and helped to reach their own conclusions; they can make an outstanding success of their careers. I wasn’t planning on writing much about business start-up or self-employment yet as I got busy with this project something happened.

There are so many business opportunities to get into these days. There are no limits because there are many new things to sell and re sell. There is always the food industry. One can sell small time as in homemade goodies being sold to mostly friends and referrals or one can go big time and open up a franchise of say McDonald's or Burger King.

There are a number of options to consider when acquiring and using credit cards for business. They include the intended use of the credit cards, approval processes for employees who are authorized to use the credit cards for business purposes, and the reporting requirements for the credit cards.

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