Main Subject - Business

Some managers think of performance appraisal meetings and recollections of torn Achilles' heels or root canals immediately surface. They're sort of "been there, don't want to go

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

again" situations. The more it can be put off, the better.

Study after study shows that both managers and employees are very dissatisfied with performance appraisals and of

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

Examples of combination products may in

ten view them as a necessary evil to get over with quickly. Here are seven strategies to turn performance management from a nightmare into a sweet, or at least tolerable, dream.

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

1. Prepare for the appraisal meeting. Give yourself adequate time to review an employee?s file, complete an evaluation of their performance and outline topi

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

cs for the session. It?s also a good idea to note some talking points and do a mental walk-through of the meeting.

The employee also needs to prepare in advance. Ask the per

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

Combination pro

son to assess his or her performance. Suggest that she also jot down concerns, questions and opinions regarding her work and suggestions for improving it.

2. Explai

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

n the reason for the meeting. When you begin the appraisal session, state the purpose of the meeting in straightforward terms. No matter how often employees have been

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

through appraisals, they may not understand how their work is being judged, why it is being evaluated or what the performance appraisal is for. Reassure the employee that your r

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

ole as manager is to help them succeed in their job and identify areas of strength and areas that need improvement.

3. Remain positive. Avoid using judgmen

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

tal phrases and words like "poor performance" or "weakness." You are there, however, to suggest ways that an employee can improve their work and discuss causes of below-average

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

performance. Express your concerns in concrete terms and use detailed examples.

4. Ask questions. Your discussion should be guided by open and closed quest

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

Following aspects would a

ioning techniques. Closed questions, which tend to elicit a "yes" or "no" response, require specific answers. Open questions encourage a general discussion and usually begin wit

dd to the challenges in developing combination products:

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

h "could," "would," "how," "what" or "why." Use open questions at the beginning of the appraisal to stimulate discussion and closed questions at the end to summarize.

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

G>5. Foster productive and open communication. In general, when you reflect the employee?s thoughts, they feel understood and acknowledged. But be prepared for negati

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

ve reactions. When you talk with an employee about poor performance or inappropriate behavior, they may deny, blame, fall silent, respond abusively or display an emotional outbu

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

rst, such as crying. If the appraisal session deteriorates, terminate it and reschedule the meeting.

6. Suggest improvements. During the appraisal, discuss

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

Professional from academic institutions, pharmaceutical industries, health care indust

any areas in need of improvement and offer specific, realistic and concrete suggestions and solutions. Be prepared to sell your improvement suggestions to the employee - they ma

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

y not be receptive to your ideas. Together you and the employee should develop a plan to correct any problems.

7. Close the interview. Summarize the major

.

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

points and be sure to end on a positive, encouraging and upbeat note - even when the employee is very troubled or deficient. If you can?t provide the employee with immediate fee

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

Companies that provide selfless information through particip

dback, follow up as soon as you can and finalize the appraisal in a timely fashion.

Work SMARTER, not harder. Make sure your performance appraisal meetings get RESULTS.

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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