New technologies, global competition, changing values and lifestyles all mean change has become an accepted way of organizational life. Change is a given and you need to handle it well!

Your role in dealing with change in the workplace is to come out the other side of the change with a positive outcome - regardless of whether yo

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

u’re heading up the change drive or having to cope with navigating the waters of an unwanted change.

Shock, Confusion, Denial, Anxiety and Fear, Hostility, Resistance, Sadness and Stress are common reactions to change. Let's look at how you and your leader can best handle each of them:

Shock: Are you content

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

Examples of combination products may in

ith the status quo? If you are, then when change is sprung upon you it may take some time for the idea to set in that you need to change. You may go into a form of shock and experience distress, disgust, surprise, grief. You may feel paralyzed - like a rabbit in front of headlights. You need time to work through your sense of

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

loss and unease. You may find your performance decreases and you only do the basic work.

Ask your Leader to: Give you emotional first aid - listen and understand your sense of loss. Keep feeding you information and reinforcing why the need for change is important. Allow time for you to come to grips with

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

he situation. When you are ready, encourage you to ask questions.

Confusion: Once you've spent time thinking about the change you are likely to be confused and have many questions. Your mind may jump in a random and chaotic way from one 'what if' question to another. There's probably plenty of rumours and s

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

Combination pro

eculation hitting you right now and you're not quite sure where the truth lays.

Ask your Leader to: Provide you with as much information as possible. Help you to see the bigger picture, yet at the same time keep you focused on short-term goals. Reassure you by taking the time to address issues and concerns

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

of both you the individual and the larger group. Work with you to develop a strategy for next steps. Stay close to the ground so that s/he can quickly address any rumours that fly around

Denial: This is a buffer zone between shock and anxiety. You may find yourself denying that the change will impact on y

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

u. You will look for evidence that the change is unnecessary - whether that's other data or people to confirm that this change shouldn't have to occur.

Ask your Leader to: Not to expect large leaps forward into acceptance. To give you sufficient time to come to grips with the change and its impact on you. H

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

elp you to see that staying in denial is risky - e.g. imagine if you were still using an IBM golf ball typewriter and all your colleagues are using Apple Macs!

Anxiety & Fear: You may now realize that change is inevitable - but the shape of the future may be murky. You might be asking yourself questions lik

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

: "How do I fit into this? Am I capable? Will it work for me?". You may be uncertain who to trust.

Ask your Leader to: Communicate directly, honestly and calmly with you - do not try to whitewash anything. Help you to fully understand how the change will impact on you and what input you can have to the chan

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

e. Work with you to create a brightness of future that you want. Don't make any promises s/he can't keep. Regularly talk to you to help you diminish the impact of the naysayers who may be pulling you down. Be a torch for you that lights your way into the future.

Hostility: Denial is often a solo e

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

Following aspects would a

vent. Once you get to anger it may mean that everyone around you knows about it. You may show your anger by active resistance and attacks on the change process.

Ask your Leader to: Put him/herself in your shoes. Get beneath the surface of the anger - what's causing it. Make sure there are plenty of forums

dd to the challenges in developing combination products:

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

or issues, feelings and concerns to be vented. Legitimize your feelings of anger, but not let you get away with it: e.g. "It's okay to be angry, but it's not okay to shout at others". When you feel that you are listened to, respected and understood your anger will diminish. To not take your anger personally and to not act in a

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

n angry or defensive manner him/herself.

Resistance: Here you'll find yourself saying things like "This won't work. They've tried it before how will this be any different? It'll happen regardless of my input. It probably just means more work for me"

Ask your Leader to: Not ask you to

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

nap out of it or pull yourself together - denying your feelings may only drive them deeper. Continue to provide you with plenty of information and timeframes for when and how the change will take place. Not force advice on you - it may only deepen your resistance. Involve you - the more you feel you have some control over the ch

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

nge the more your resistance will lessen.

Sadness: Feelings of sadness at your loss or perceived loss may occur. Whether you see the change as positive or negative, as you leave behind the familiar past, you may experience some sadness. This is a normal response as it helps you to understand how much you r

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

Professional from academic institutions, pharmaceutical industries, health care indust

eally care about something.

Ask your Leader to: Talk about your feelings and what is causing them. Help you to find ways to manage your feelings and thinking patterns. Make sure you are taking enough time for physical exercise, rest and good nutrition. Help you to get help if your sadness begins to show the

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

symptoms of depression.

Stress: Stress will generally occur when you feel like you have no control over the change. You may find yourself feeling ill. The most harmful kind of stress is social isolation.

Ask your Leader to: Help you to seek out the support you need - whether from family

.

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

, work colleagues, friends or by giving you access to a professional counsellor. Put you in contact with stress reduction resources such as meditation, relaxation tapes, breathing techniques etc.

Dealing with change in the workplace is a fact of life. As you let go of the past, be patient with yourself, tell yours

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

Companies that provide selfless information through particip

lf the truth (if you're sad or worried acknowledge it), stay focused and involved. As you move through the winds of change you will learn much about yourself. As Napoleon Hill is often quoted "Within every adversity is the seed of an equal or greater benefit". Look for your seeds as you are dealing with change in the workplace

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products