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Many organisations have set up appraisals systems. Those that are most effective include 360 degree feedb

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

ack. So what is 360 degree feedback and how can you start to put it in place?

360 Degree Feedback

The b

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

Examples of combination products may in

sic concept behind 360 feedback is getting views from those that manage you, those in your peer group and

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

hose that you manage. The idea is to get a rounded picture of your performance from a number of different

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

sources in order to build up a picture of your strengths and development needs. In a well designed 360 fe

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

Combination pro

dback process you will also complete your own self assessment.

When you are first faced with the possibil

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

ity of 360 feedback it can be daunting. The reality is very different. You discover:

1. Qualities that y

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

u never even noticed in yourself

2. People are delighted to have the opportunity to contribute to your gr

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

wth

3. You are often your biggest critic and people think much more highly of you than you do

4. Where g

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

eatest benefit will be derived from your personal development activities as you will know where to focus y

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

ur attention

5. You have many more strengths than you have development needs

Setting up 360 Feedback

Th

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

Following aspects would a

ere are a range of options open to you and one consideration will be financial. At the most basic level,

dd to the challenges in developing combination products:

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

ou can send out an e-mail to people. Another alternative is to use software of there is a system in your

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

ompany. There are also options to use technology even if your company does not have its own computer pack

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

ge. A Google search will identify some options.

In terms of those that you ask for feedback:

1. Aim for

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

about 10-15 people

2. Have a range of managers, peers and subordinates

3. Choose some people who you ant

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

Professional from academic institutions, pharmaceutical industries, health care indust

icipate will give you a high rating

4. Choose some people who you will anticipate will give you a low rat

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

ng

5. Choose some people who you are unclear as to how they will rate you

When carrying out your own sel

.

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

assessment:

1. Don’t forget to recognise your strengths

2. Be honest with yourself

3. See weaknesses a

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

Companies that provide selfless information through particip

an opportunity for development

Go on give it a try and see the power of 360 degree feedback for yourself

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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Most of the businesses these days borrow money either in short terms or long terms basis. The majority of cash flow statements illustrate the increase and decrease of the earnings of the short term debt only. It does not report the total amount that are either borrowed or paid. On the other hand, when illustrating a long term debt, the total amount and the reimbursements of the long term debt must be indicated in the cash flow statement on a yearly basis. The figures on these cash flow statements are illustrated on gross not net figures.

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