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A Counsel Interview is a practical approach to dealing with staff problems - and all such situations. Issues rarely solve themselves and therefo

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

re it is essential that managers recognise that a problem exists and then solves it as rapidly as possible, because an unhappy employee will not

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

Examples of combination products may in

be working at optimum performance levels.

Step One: Decide to Hold a Counsel Interview

Where a situation is wrong, and is obviously go

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

ing to get worse, take the positive decision to hold a counsel interview, it is the only way. Face the problem - do not simply hope it will go a

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

way. Prepare for the interview by brushing up on the interviewee’s background. Give the interviewee a general idea of what the interview will be

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

Combination pro

about when arranging the time and place to have it. When that time comes, make certain that the meeting will not be disturbed in any way.

S

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

tep Two: Uncover the Facts

Ask questions to get the other person talking. It may be that the answers to some of the questions are already k

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

nown. That does not matter. What is being looked for is a key, something to unlock and let out the real cause of the worsening problem. Get the

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

person to unburden themselves.

Step Three: Agree the Cause of the Problem

Once the interviewee has admitted there is a problem and give

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

n the details, the counsellor can start to rebuild the situation. Only after such a frank discussion can the real causes of the problem be agree

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

. This agreement is essential to a cure. Without it there is a strong likelihood that it is effects, not causes that are being dealt with.

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

Following aspects would a

Step Four: Allow Interviewees to Speak for Themselves

In any situation like this it is much better for the interviewee to solve their own p

dd to the challenges in developing combination products:

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

roblem. So, let them talk and provide their own suggestions for what should be done. That way they will have a far higher level of commitment to

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

taking action.

Step Five: Decide the Course of Action

The counsellor has to listen to the interviewee’s suggestions for putting the si

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

tuation right. Between them they can then agree what should happen. This is a vital stage. Always establish a programme for the course of action

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

to be taken.

Step Six: End with Positive Agreement

The counsellor and interviewee have thoroughly aired the problem – and agreed what

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

Professional from academic institutions, pharmaceutical industries, health care indust

to do. At the end the interviewee will feel much better. This is partly due to having had the opportunity to talk; and partly due to being able

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

to see an end to the trouble. Make sure that any counsel interview ends up with positive agreement - a commitment from both sides to solving the

.

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

problem.

Summary:

As Managers, you are responsible, primarily, for those reporting to you. Know them well and keep an eye open for a p

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

Companies that provide selfless information through particip

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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