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Change is inevitable and it will happen with your help or without it. You may be a traditional person who likes life as it is. But your life has changed all around you since your childhood and it will co

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

ntinue to do so for you, your children and theirs. Of course, you don't have to like it and you can even resist it but you will not stop it. To be an effective manager you must try to understand change

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

Examples of combination products may in

and use the benefits to your and the company's benefit. You have a greater problem than most other people do because you have to overcome your own natural resistance to change and convince the people tha

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

work for you too. Factors which affect our attitude to change

Overcoming the fear of change

The biggest problem with effecting change is the fear that it creates.

· Feeling too old t

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

learn new techniques or technology

· Changes in relationships in the working team

· Fear on being embarrassed in front of others

· Fear of losing promotion opportunities or even their own job

Per

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

Combination pro

onal sense of security

Worries about security caused by mortgage, marriage, divorce, debts, all make people more liable to resist change because any new situation feels less secure than the known si

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

uation.

Habit

If someone has grown up and lived with a lot of change they accept change as normal. There will be more resistance from someone who has done the same job and lived in the same plac

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

for a long time.

Social and cultural beliefs

These will be related to a particular community, class, trade or even work-group where historically they have been the victims of change rather than

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

the beneficiaries.

Past experiences

The world is full of horror stories about the effects of change. Many people have suffered as a result and do not relish going through it all again.

Reduc

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

ng Resistance

Change management is a relatively new management concept and it is a complex subject but the following tips will help. Remember that most of your changes will affect you directly but

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

any will have indirect effects on your group. Let's look at two ways that you can adopt to reduce the negative effects of change.

Be strong and confident

This easy to say, isn't it? Many of the

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

Following aspects would a

new things that we are going to adopt will feel strange and you may be embarrassed or nervous to try them for the first time. Remember the first time you dived into a swimming pool? Just do it. The next

dd to the challenges in developing combination products:

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

ime will be easy.

Empathize

Do you remember this word from a previous module? It means putting yourself in the other person's situation and try to anticipate his concerns. Then you act to inform

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

him or reassure him or whatever is necessary. Major change needs far more consideration and actions.

MAJOR CHANGES

TAKE THE HARD DECISIONS QUICKLY - If change means that people need to

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

e moved or even dismissed then do it as quickly and humanely as you can.

REASSURE THE REST - Once the hard decisions have been made then reassure the rest that they are an important part of the f

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

ture. Remove the fear.

INFORM - Keep people informed about what is going on. You may not be able to tell them everything but tell them what you can. If you don't inform them then the grapevin

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

Professional from academic institutions, pharmaceutical industries, health care indust

will.

INVOLVE - If people feel that they have an involvement in the planned change (part ownership) then they will usually respond positively. If it has been imposed on them then they will

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

have less commitment to making it work.

SELL BENEFITS - If participants see the benefits of change as a way of reducing their problems and not of increasing them then you will be supported.

A ch

.

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

nge strategy is very likely to fail if management:
· Fail to consider people and the threat to their roles and positions
· Fail to consider the difficulty people have in changing their ways

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

Companies that provide selfless information through particip

· Fail to provide effective training so that the new skills can be learned and accepted
· Fail to define the results expected
· Fail to monitor the change and provide guidance as neede

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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