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--PREPARATION: The purpose of the therapeutic approach is to spark an employee toward improved performance through counse

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

ling. The manager’s goal is to help the employee recognize the existence of a problem, accept the need for change, and fo

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

Examples of combination products may in

rmulate his or her own program for improvement. The manager should critically assess his or her own attitudes and opinion

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

s. It is important to try to eliminate all personal bias and prejudice or at least be aware of any such emotions no matte

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

r how little effect they seem to be having. For the most positive results, the manager should be noncritical or at least

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

Combination pro

noncommittal toward the marginal performer. In addition, the interview should be conducted in private, without interrupti

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

ons, and with adequate time.

--SETTING A COMFORTABLE ATMOSPHERE: The employee should be made to feel relaxed and at ease

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

It is particularly important that no mental anguish is spent in guessing the interview’s purpose. It is not necessary fo

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

r the manager to “build the employee up” with praise about favorable performance but it is desirable that the atmosphere

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

is friendly and constructive.

-- STIMULATING SELF-APPRAISAL: The simplest, most forthright tactic is to explain to the e

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

mployee that there are problem areas. Elicit self-analysis from employees about their jobs, particularly focusing on thos

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

Following aspects would a

e areas where they feel that their performance could be improved. Once employees begin discussing unsatisfactory performa

dd to the challenges in developing combination products:

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

nce — or at least elaborating on problems they are encountering on the job — the manager can pursue the problem areas. As

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

king, rather than telling the employee, becomes the key to an effective discussion. Through these questions, the manager

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

eeps the employees on the subject and gets them to suggest ideas on improving performance.

-- STIMULATING SELF-SUGGESTIO

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

N: Once the employee has begun to make positive suggestions, the manager should encourage exploration of these ideas in d

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

Professional from academic institutions, pharmaceutical industries, health care indust

etail to determine which ones will be most useful for self-improvement. The manager should interfere as little as possibl

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

e in the employee’s self-evaluation. Offering suggestions to the employee will likely negate the whole process. The emplo

.

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

yee’s defense mechanisms are always lingering in the background, and they may surface the minute the manager begins to pr

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

Companies that provide selfless information through particip

ess the employee into following a course of action, thereby defeating the purpose of the therapeutic counseling interview

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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