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Why do we human beings complicate things? Is it that we don’t believe that simple things work. Fr

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

om years of working with leaders at all levels and many different sectors here are the simple yet

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

Examples of combination products may in

powerful steps you must take if you want to be a brilliant leader.

* Know your people – not just

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

as cogs in a machine - but also as people. The more you know the more you can do to assist them d

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

o even better.

* Keep asking people how things are going – what needs improving – what we can do

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

Combination pro

better?

* Decide today to delegate twice as much as you’re currently doing. You’ll see in this w

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

rkshop that you DO have people to delegate to even though it may not seem like it.

* Check peopl

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

e’s understanding of your instructions by asking them to tell you what they have to do. Don’t jus

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

ask, “Do you understand?” They may say “yes” even if they don’t!

* Always get clear in your own

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

mind what you want from projects, meetings, presentations, and appointments. A leader knows what

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

e/she wants and this keeps everyone focused.

* Make the effort to genuinely praise people privat

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

Following aspects would a

ely – and even better - in public.

* Keep people regularly informed – about as much as possible.

dd to the challenges in developing combination products:

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

You’ll see why in more detail during this workshop. Communication can be short and to the point b

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

t people want to know.

* Consult as much as possible. Ask people how they’d do things and whethe

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

r or not they’ve better ideas on how to do what you want.

* Set direction and decide. Make clear

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

what the purpose of the company, department, and project is. Set out some short-term targets and

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

Professional from academic institutions, pharmaceutical industries, health care indust

ome medium term visions then decide.

* When people are not performing well strive not to insult

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

or belittle. Be hard on the problem not on people. If you have to fire someone do it with as much

.

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

dignity and respect as possible.

Yes we should read more and attend more workshops to keep impro

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

Companies that provide selfless information through particip

ing. But what more do you need? Go and do it now!

You can be an even better leader - all success

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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You've worked hard to get your business up and running and you are starting to get a good customer base – so how do you make sure that they do not forget you?

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