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Here are 20 of the tips that we at WorldGAMES use when training others to tra

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

in:

Always use a simple frame-up that sets tight rules for the t

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

Examples of combination products may in

raining

Acknowledge participants and draw out their

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

> benefits for the training (not yours)

Get participant b

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

y-in to rules and benefits

Seek to influence with integri

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

Combination pro

Walk your talk

If you do not know

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

something ... say so

Care about participants and show it

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

Ask plenty of questions

Listen, watch

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

and get a feel for where your audience are at - constantly

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

Draw out participants' experience - collectively the group knows more than

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

you

Honor participants' experience of the activity - do n

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

Following aspects would a

ot tell them what they felt

Paint pictures, use metaphors

dd to the challenges in developing combination products:

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

and war stories and keep them short and relevant

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

e a coach, guide and facilitator rather than a preacher or teacher

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

Accept that participants will see the world differently - honor the

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

ir model of the world

Appeal to all learning styles whene

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

Professional from academic institutions, pharmaceutical industries, health care indust

er possible (visual, auditory and kinaesthetic)

Handle ho

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

t issues - avoid them at your peril

Be cautious with humo

.

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

r - it is easy to offend

Involve the whole group at all t

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

Companies that provide selfless information through particip

imes

Be yourself

Be open

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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