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A leader’s role is to focus on those areas of operation where he or she can deliver the greatest value and this requires h

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

uge shifts in perspective of the role. Leaders differ from managers in terms of accountability.

Whilst a leader i

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

Examples of combination products may in

accountable for the strategic growth of the organisation and the delivery of results, a manager is more responsible of de

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

ivery of shorter-term results through people.

These are, of course, generalisations and roles vary.

Developing others

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

/b> through delegation is a great way to grow skills and confidence in your workforce. Through utilising the viewpoints o

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

Combination pro

others, you create the variety of solutions which might well escape you, from your own experienced, though single perspec

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

ive.

As well as radically improving the quality of your workforce, the leader who works in this way also does much

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

more for their own focus. If a job can be done at the lowest possible cost level, true with some training and on the job

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

coaching, then that frees you up for the role you're being paid for too.

Your Q2 time (see 'The Seven Habits of Highly

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

Effective People' - Stephen Covey) multiplies and you can start to use your own creative skills in the bigger f

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

amework.

To grow and develop your business or organisation. Safe in the knowledge that you have great people arou

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

Following aspects would a

d you and they are realising their own potential too.

An exercise to consider!

Make a list of those thing

dd to the challenges in developing combination products:

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

you currently do, yet someone else could do.

Decide to give up 20% of your role to others within your organis

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

tion within a defined timescale (1 – 3 months). 50% within a year. Value your time for what your strengths can uniquely

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

provide.

Check out your own, personal ‘nice-to-do’s’ rather than ‘need-to-do’s’. I.e. is it something you are choosi

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

g to do because you like doing it ahead of it being important enough?

Review how the extra time can be best us

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

Professional from academic institutions, pharmaceutical industries, health care indust

d to deliver the more challenging parts of your role – especially regarding future goals and visions.

S

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

ot check that you are also enabling others to develop and remember that they may well require clarity and coaching

.

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

n new activities to start with.

Doing the 'stuff' you do, rather than achieving your true worth, is escapism

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

Companies that provide selfless information through particip

it is finding things to 'do' rather than thinking, creating, challenging and firing yourself up.

So it's time to step up

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 - Delegation for Business Leaders - How Letting Go Works

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