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If I had $1.00 every time I heard someone say “ I don’t like change or, change makes me uncomfortable” I’d be a millionaire. Some people thrive on change – they love it and even create more of it. Others v

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

iew change with anxiety and resistance. So often, we don’t associate potential, excitement and wonder with change. Instead, we react to it; we try to control it; we create situations and problems to avoid

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

Examples of combination products may in

dealing with it. We experience change daily in many forms – the clothes we wear, the food we eat, the conversations we have, traffic patterns, the WEATHER.

While change is a constant in life, some changes

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

(mergers and acquisitions, downsizing, reorganizations, job relocations, promotions, divorces, marriages, war) affect our lives on a bigger scale with impact on multiple areas of our business and personal

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

lives.

One of my clients has been in business for eighteen years. Up until five years ago, her business was thriving. In the period of one year; her client base was reduced by 50%, dramatically affecting

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

Combination pro

her net income and her entire life! The timing couldn’t have been worse. She had just purchased a new home, a new car, and tickets for an Alaskan holiday. It felt like the rug had been pulled out from und

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

er her with so many changes happening all at once! Being in transition (the process or an instance of changing one form, activity, state, or place to another) brought up uncertainty, confusion, anxiety and

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

the “F” word. FEAR. Big Time! Re-evaluating her values, life purpose, and needs helped her to identify new business directions and goals with greater clarity and confidence. Five years later, it’s a whole

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

new ball game with plenty of home runs.

Creating a Defensive Strategy

If you’re facing (or anticipating) one change of several changes, these tips will help you navigate through transition and hel

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

p you land on your feet:

1. Acknowledge what’s happening. Get real about your situation and eliminate denial. Identify what you can control and/or influence to gain perspective in devising a strate

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

gy for action.

2. Invite collaboration. Brainstorming is an excellent resource for pooling knowledge by gathering other points of view for creative problem solving.

3. Ramp up self-care. Ta

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

Following aspects would a

king good care of yourself physically, mentally, emotionally, and spiritually is a key factor in staying strong and focused. Establishing some daily routines/habits provides consistency and a sense of cont

dd to the challenges in developing combination products:

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

rol. (exercise schedules, morning and evening routines).

4. Need to vent and/or have someone just listen? Build a support team of family, friends, colleagues and or professionals who will hear you

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

with objectivity and encouragement. Sometimes we just need to be heard!

5. Interrupt and replace negative self-talk. Fear tends to view situations through a narrow lens with an emphasis on problema

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

ic thinking and worse case scenarios. Take charge of your attitude. Instead of focusing on the worst, expect the best.

6. Be engaged in pleasurable or stimulating activities. Lighten up and take ti

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

me to relax with friends and family.

7. Recall a past experience you successfully transitioned. How did you do it? What can you take from your past success to use in future experiences? Drawing fro

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

Professional from academic institutions, pharmaceutical industries, health care indust

m personal history builds confidence and stirs the creative juices.

8. Be curious. Ask yourself – “How does this situation compel me to grow? What can I learn about myself, my life from this change

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

? What opportunities does this change offer me? What can I take from this experience to improve myself/my life? Use what you discover to move you forward.

9. See yourself in the future, at the othe

.

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

r side of the transition. Create a vivid picture in your mind of how you see your life. Incorporate this image as part of your daily routine (see #3) and use this picture to pull you forward through your t

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

Companies that provide selfless information through particip

ransition.

No matter what is happening in your life, the one power you always retain is how you choose to view yourself and your situation. It’s your life; make it the best!

Copyright 2003, Lorraine Cohe

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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DVD vending machines are just one of the many types of unusual vending machines making their way over from Japan. In Japan, many products are available from vending machines.

What is the best way to find accounting services in your area? Whenever I look for any service, there are certain processes I go through. Though services may vary, many of the strategies I use to find different ones are pretty much identical. The best thing you can do when seeking accounting services in your area is to do your homework. Do some research so that you know what your options are inside the scope of what exactly you want and at what price you want to get it. Finding an accounting service is really no different than finding any other service in your area. Here are some tips that may even help you do just that.

I was talking to someone a few weeks ago, and explained that I thought our decision-making process should be based on three inner criteria: intellect, intuition and emotion.

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