Useful Advices - Business

They say there are three types of participant on a training course, Prisoner, holiday makers and time wa

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

sters. Prisoners and being held against their will and have been made to go by someone else, usually th

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

Examples of combination products may in

eir manager who wants to look like they are doing something to help. Unfortunately, they can be quite o

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

utward with their displeasure! A comment to define these guys by are “Do I have to be here?” Remember

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

ot to take it personally!

Then you have the time wasters, they are in the training to avoid work mainly

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

Combination pro

or have a chat and a laugh with their mates perhaps they’re disillusioned with their role or whatever,

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

but the reality of it is that they are not there to learn. One way to identify this behaviour is by obs

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

rving apathy to the subject, fooling about, not listening etc.

Finally we have the holiday makers. The

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

se are people who want to be there and are prepared to make the best of it.

Now just before we lavish a

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

ll of our attention on the holiday maker, who really do want to learn! What about the other two categor

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

es? How do we engage them?

Well firstly, you need to find out who’s what on this particular course. R

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

Following aspects would a

emember that individuals that make up the prisoners and the time wasters will only act this way in certa

dd to the challenges in developing combination products:

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

in environments that they find inappropriate to them, they don’t act this way all the time, so be tough

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

on the behaviour and soft on the person.

I’m not going to recommend any touchy feely ways to look for s

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

gnals either. I am simply going to suggest that you ask them outright!

I used this myself quite recent

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

ly to great effect. It’s a really great way to break the ice and start the day and its different from t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he usual “What does everyone want to get out of today…” “a nice lunch!” You know what I mean!

At the

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

tart tell the group about the three categories and ask them to identify themselves.

Once they have done

.

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

this, you as a trainer can ask about ways that you can change their perspective and give them value fro

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

Companies that provide selfless information through particip

m the day.

This promotes an honest and transparent relationship between you and the participants!

Enjo

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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