Advice You - Business

It’s easy to say it's only a job. And the monetary compensation of a job is certainly a means to an end. If this is not enough and you are stressed by one-too-many seemingly perplexing and frustrating moments at work, consider these possibilities.

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

1. Make sure other areas of your life are fulfilling, e.g. family, social life, physical activity, spirituality, community, etc.

When things aren't going well in more than one area of your life it's like trying to balance on a tight rope w

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

Examples of combination products may in

hile standing on one foot. Build up your satisfaction in other areas of your life, so you don't have to pick up that other foot and head for a fall.

2. Change the viewing or the doing. (Source of phrase: Bill O'Han

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

on, Author of 'Do One Thing Different: Ten Simple Ways to Change Your Life.')

How can the situation be reframed or viewed so that you can live with it OR how can you DO something about the situation?

Not in the job that y

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

ou want? What can you learn from it that you haven't noticed yet? Interview a colleague to get a perspective (change the viewing) OR find another assignment (change the doing).

3. No More Excuses.

If you find yourself saying, 'If

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

Combination pro

nly he/she/they/the company would _______,' determine what you are going to do if he/she/they/the company doesn't________.

4. Employ the Gandhi Method.

At some point we all have probably been on the receiving end of this old manag

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

ement tactic. We raise an issue only to get assigned the task to deal with it. But then, what is so bad about that? I say pre-empt those management tricksters and assign it to yourself, employing what I call the *Gandhi method.*

Be the change you

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

want to see in the world. – Mahatma Gandhi

5. Get It Taken Care Of.

If Point 4 isn't working, get that need met somewhere else. What I call a “sideways” approach, can work. If you can take all your focus off of the current

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

hot spot,” you create room for movement or new ideas. (Bonus tip: Don’t get hung up on identifying the one-perfect step. Just take some step in the general right direction.) Examples:

Seek challenge by taking a class, volunteering, etc.

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

li>Seek advice for dealing with toxic relationships on the web, through books, etc.

Not feeling appreciated? Ask family and friends for encouraging feedback.

6. Having Buddies Is Good.

Build or maintain an active ne

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

work of friends, family members, and colleagues to make sure you have enough support and objective perspectives to help you cope.

7. Interview people who appear to be enjoying their work.

Sometimes it helps to hear from someone wh

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

Following aspects would a

o seems to be doing just fine. Seek those people out. It only takes one new idea or perspective to re-energize or inspire you. You’ll want to find out what has allowed some people you respect and admire to work/live in your organization.

8.

dd to the challenges in developing combination products:

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

Research interesting jobs or create your own job (really?).

Many companies have an internal job posting mechanism. Check it out regularly. Even if you don't feel you meet the requirements of the job, if it looks interesting, interview the pe

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

son in charge to learn more about that type of work.

Another option -- while meeting the expectations of your current assignment, start doing things that interest you and clearly add value to your company.

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

While running a manufacturing project, I began working with teams in the areas of valuing diversity, respectful treatment in the workplace, and career/skill development. This evolved into a full time assignment for me.

9. Darn, I’m Good!
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
ng>

There was a point in my corporate career when I was required to document how I was qualified for my current assignment. I really resented having to do that, but after investing over 20 hours on this task, and compiling a 1-inch thick file, I realiz
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
d how much I had to offer, whether I was with my current employer or not. That helped me to feel not so vulnerable.

10. Sit with the Discomfort.

What do you do when you have tweaked your situation
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to a point of exhaustion, put your best into exploring other options or making your environment better and there is still a noticeable, more-than-annoying dissatisfaction? Maybe it is time to just sit with it. Contrary to what you might think, I don’t me
.

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
n, “give up.”

A Final Note…

If you find that no amount of tweaking of your current job, career, or situation seems to be working, know that you are not alone and this is a
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
perfectly normal part of the career development cycle. It might just mean that you’ve outgrown your current situation and are ready for a new challenge.

Copyright 2004-2006, Mary C. Schaefer, all rights reserved

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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