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Now more than ever you need to take charge of your career! Our work environments are rapidly changing. Lifelong employment is a thing of the past and the thr

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

eat of layoffs loom ahead. Organizations are now flatter with fewer management layers, which results in fewer promotional opportunities. Employees need to do

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

Examples of combination products may in

more with less and become more flexible to quickly learn new skills and adapt to change. As a result employees need to own their development and actively mana

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

ge their career in the midst of change.

Now is a perfect time to assess your career and your development. What do you hope to accomplish in your career? Wha

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

position or role do you aspire to? What specifically do you want to achieve in the next year? Write down your career goal. Here’s one example, “Become qual

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

Combination pro

fied to attain a management position by the end of the year.”

How are you going to achieve your career goal? To best accomplish your goal, create a written d

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

evelopment plan. Your development plan should include development objectives, measures, development activities, and a timeline.

Development Objectives

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

Ask yourself, “What knowledge, skills, or abilities do I need to develop to reach my goal?” Say, for example, you aspire to a management position. If so, th

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

n you need to determine the skills required of managers and identify those skills that you need to develop. Look at several sources of feedback on your skills

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

. Solicit feedback from your supervisor, review past performance evaluations, and complete a skills assessment.

Select one to three development objectives to

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

work on this coming year and write them down. For example, 1) develop project management skills, 2) develop leadership skills, and 3) develop and improve my a

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

Following aspects would a

ility to cope with change.

Measures

For each development objective, identify how you will measure it. Ask yourself this question, “How will I know th

dd to the challenges in developing combination products:

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

at I’ve been successful?” Your measures should be specific, measurable and realistic. Let’s say you want to increase your effectiveness in building support f

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

r your ideas. Your measure might be to influence at least three of your peers to accept your ideas.

Development Activities

Which learning activities

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

ill help you to develop your skills? These can include a whole host of activities, including reading books, listening to audiotapes or CDs, taking a class, sh

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

adowing someone on the job, interviewing an expert, working with a mentor, taking on challenging projects, etc. Shadowing and projects are great learning vehi

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

Professional from academic institutions, pharmaceutical industries, health care indust

les. Research shows that people learn best by observing experts and by taking on “stretch” assignments. Identify several activities to help you develop the s

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

ecific skills you’ve identified.

Timeframe

Finally, identify a completion date for each development activity. Make sure you choose a timeframe that i

.

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

s realistic for you.

A written development plan will provide a framework and focus for your development. By following your plan to develop yourself, you’re s

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

Companies that provide selfless information through particip

gnificantly more likely to achieve your career goal. Ultimately, your development and your career are up to you, so take the time to focus on your development

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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