References - Self Improvement

1. Differentiate yourself using a Personal Value Proposition. A PVP a description of how your unique mixture of five key elements creates and/or adds value for an organization and the people

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

in it. A personal examination of these elements reminds you of all the strong, positive things you bring to the table and it points out the gaps you need to close before you can position yo

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

Examples of combination products may in

urself more effectively. Examine each element separately, combine all the data and created a succinct summary of what you have to offer.

The five elements are:

The knowledge you

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

ave about the events and trends in areas critical to or of most interest to your company and clients;

The kinds of internal and external networks that you can tap into to meet corporate

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

/client needs;

Your ability to generate and implement superior solutions to organizational issues and concerns;

The academic, technical, or interpersonal tools you can bring to bea

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

Combination pro

in key situations and; finally,

The personal attributes and strengths you have that sets you apart from others in the organization.

2. Describe yourself in terms of the outcome

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

s you create, not the activities you engage in. Fashion a one-line proclamation, a marketing slogan if you like, that reflects the outcomes you create for your company and its customers.

3.

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

Make it your personal mission to always make others, including your boss, look good. Someone once said, “you can have anything you want; all you have to do is give others what they want.” Wh

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

ile there is the odd exception to be sure, most people are fair and honest—willing to share credit where it’s due. Making others look good sweeps you up in their success and almost guarantee

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

that they will help you enjoy successes of your own.

4. Be a can-do person; take to heart the words of the old song, “the difficult I can do right now; the impossible will take a little wh

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

ile.” Instead of saying “I’ve never done that,” say, “I’ll learn how to do it.” Don’t be afraid of steep learning curves. Remember the organization hired you because you were smart. Look for

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

Following aspects would a

the opportunity in difficulties rather than the difficulties in the opportunities.

5. Develop success from failures. Don’t be afraid to fail or make mistakes. But if you do either take res

dd to the challenges in developing combination products:

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

onsibility—don’t project or rationalize. Admitting a mistake or failure and moving forward is proactive not reactive. Above all, identify and remember the learning opportunities in the situa

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

tion. Forget about everything else and move on.

6. Ask for help. IQ expands exponentially. Together, two people bring four times the intelligence. Super-hero individualism is often counter-

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

roductive.

7. Remember the Pareto principle, or the 80/20 rule as it’s more commonly known. Eighty percent of your effectiveness comes from twenty percent of your activities. Manage your pr

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

iorities and don’t waste time spinning your wheels by engaging unimportant activity.

8. Get yourself in front of an audience. Learn to make effective presentations and make as many as you c

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

Professional from academic institutions, pharmaceutical industries, health care indust

n. Good presentations are the mark of a true professional. You, your ideas and skills receive broader corporate exposure that, in my experience, can result in challenging new assignments, la

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

rger budgets, greater general recognition and even raises and promotions.

9. Develop and use internal and external networks, both formal and informal. People who network well often receive

.

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

nd move information faster, cut through organizational politics more quickly and, create solutions better suited to the needs of their companies. Research in different types of organizations

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

Companies that provide selfless information through particip

shows that those who develop and use networks usually get to serve on more successful teams, receive early promotions more often, get higher compensation, and get better performance reviews

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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