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In numerous programs I’ve conducted on performance appraisals, with Human Resource people (who are responsible for developing and implementing programs) and with line managers (who actually conduct the rev

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

iews) are often foggy about performance appraisal procedures. Here are some frequently asked questions.

Questions asked by HRD Professionals:

1. What are the essential ingredients of an effe

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

Examples of combination products may in

tive performance appraisal program?

A successful program must meet the following requirements:

It fits the organization, rather than ‘one size fits all’.
It must be communicated t

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

all involved.

It must be sold to those who will conduct the appraisals.

It provides training and ongoing resources to managers.

It establishes controls and rewards to reinfor

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

e implementation.

2. Can I use other’s forms and procedures or must I develop a whole new program?

You certainly can see what other organizations are doing in relation to performance

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

Combination pro

ppraisals. However, I say adapt appropriately not adopt totally. What works for a large financial institution may not work in a family owned business. Use other programs as a guide, not a boilerplate.

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

et input from your line managers as well as employees regarding forms and procedures – they are the ones who ultimately will be the users.

3. Why do managers generally dislike performance appraisal pr

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

grams?

Many managers are not convinced that the program is a good one or that positive results will be gained. Also, they are not properly trained to conduct the reviews. They hesitate to e honest f

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

r fear that subordinates will resent them and believe the review will be an unpleasant experience that might cause more harm than good. (This may be right if the program has not been properly planned and

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

mplemented.)

4 How much training is required and how should it be done?

Training must include three factors: basic HR information, performance appraisal skills and motivation to implement the pro

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

ram. Ideally it should be done in multiple sessions spread out over a period of time with small groups for proper discussion and practice. Some of the key topics could be how to clarify what’s expected;

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

Following aspects would a

ow to conduct an effective review; how to rate fairly, etc.

Questions asked by Line Managers:

1. Why do most subordinates dislike performance appraisals?

Because it is often an unpleasant

dd to the challenges in developing combination products:

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

xperience! Some common problems cited are:

Expectations and outcomes are not clear.
Fear to disagree with the boss and that it will be held against them.
Criticism is used m

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

re often than praise.

Bosses are defensive when challenged by subordinates.

Bosses aren’t prepared.

2. How can I be sure I’m making a fair appraisal?

First of all,

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

sk for input from others who are in a position to evaluate the performance of the person. Next, be sure that neither the ‘halo effect’ (a positive opinion of the individual) not the ‘horns effect’ (a nega

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

ive opinion of the person) influences the appraisal. Also be sure that the appraisal is not based just on the most recent events.

3. How can I get the person involved so I’m not doing all the talking?

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

Professional from academic institutions, pharmaceutical industries, health care indust

/i>

To encourage dialogue during the review, you can ask such questions as: What went well this past year? What problems did you encounter? What are some key goals for the coming year? What areas do you w

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

nt to improve or develop? How can I best help you to achieve these goals?

4. How should I end the review particularly if the person is not doing a good job?

Always end on a positive note. First,

.

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

hank the person for some specific good work done the past year. By recognizing achievements you create the motivation to achieve even more. Then move on to the area that needs improvement. Say something l

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

Companies that provide selfless information through particip

ke, “I’m glad we had a chance to talk about your performance and how we can work together to improve it. I’m sure that together we can achieve positive results.”

Don’t just appraise but raise performance

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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Digg It - Performance Appraisals: Questions for Smarties and Dummies

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