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Just about anyone can explain what they know, or demonstrate how to

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

do a skill that they've learned. And both of these can be, at time

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

Examples of combination products may in

, effective ways of teaching. But these are not the only ways to te

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

ch. And for many students, these are not the most effective ways to

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

learn.

Certified trainers know how to teach the same topic several

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

Combination pro

different ways so that their point gets across to all of the studen

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

s, not just a few. They know how to recognize when students are hav

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

ng trouble with the topic, and they know how to help the students t

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

at need extra help. They are also very good at designing group work

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

and hands-on projects, as well as practical problem-solving situati

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

ns. These are all very effective methods of teaching that are often

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

Following aspects would a

ignored by trainers who have not attended a Train the Trainer train

dd to the challenges in developing combination products:

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

ng workshop.

Other skills that certified trainers have which uncer

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

ified trainers usually don't:

• scheduling breaks after appropriat

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

learning “chunks”
• getting diverse groups of students to wo

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

k together cooperatively and productively
• scheduling in tim

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

Professional from academic institutions, pharmaceutical industries, health care indust

for getting off the topic a little, as often happens in a class

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

> • keeping the students on track, when necessary
• ensuring

.

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

that students treat each other with respect
• ensuring that o

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

Companies that provide selfless information through particip

ten ignored and overlooked students get equal learning opportunitie

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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