Digg It - Business

As in any aspect of life, if you want to get somewhere, you have to know where you are go

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

ing. Otherwise, you get the results you've always gotten and wonder why things never chan

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

Examples of combination products may in

ge.

The same is true when designing training programs. In my field of performance consul

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

ting, I often talk to prospective clients about their past failed training programs. The

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

omment usually sounds like, "Well, we tried that before and it just didn't work." My resp

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

Combination pro

onse is to find out what preparation was done prior to creation and delivery of the train

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

ing.

In most cases, where "training" failed, the reason for the training was not properl

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

y identified and clearly linked to the business requirements. Or, management threw traini

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

g at the problem, without truly assessing and understanding the core problem. Training pr

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

ograms that lack a connection with an established business objective are often doomed bef

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

ore they begin!

Key Questions Prior to Training Development

1. What business problem ar

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

Following aspects would a

e you trying to solve?

2. Will all levels of the organization be included in the process

dd to the challenges in developing combination products:

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

3. What will success look like upon completion of the training program?

4. What obstac

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

les will potentially hinder the implementation of skills learned?

5. What are the conseq

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

uences for those that do not participate in the training?

6. What are the consequences f

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

or those that do not adopt the skills learned?

7. How will you measure success?

If any

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

Professional from academic institutions, pharmaceutical industries, health care indust

f these questions are left unanswered prior to development or design of a training progra

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

m, the door is left open for failure, either in the application of the skills learned, or

.

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

the justification of the training program in the eyes of management. Answer these questi

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

Companies that provide selfless information through particip

ons clearly and everyone will understand what's at stake and recognize successful results

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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