Main Subject - Business

What is the culture in your organization? When mistakes are made what is the fi

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

rst question asked? "Who's to blame?" or "What can we learn from this?"

If the f

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

Examples of combination products may in

rst question is "who is to blame," you may be creating a culture of fear and int

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

midation. The result of this culture is to stifle creativity and progressive thin

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

ing while fostering an environment where everyone plays the C.Y.A. (Cover Your A

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

Combination pro

__) game.

Failure to learn from mistakes results in crisis management because eit

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

her no decisions are made out of fear of making a bad one, or bad decisions are

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

epeated because no one knows the correct response.

However, when you foster an

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

nvironment where mistakes are seen as opportunities to learn rather than point f

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

ngers the result is better decisions, greater accountability (people are more pr

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

ne to admit an error if they know their head won't be cut off as a result) and c

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

Following aspects would a

ontinual growth and improvement.

Try this approach:

1) Check out the facts (don

dd to the challenges in developing combination products:

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

t go by what others tell you, they may be playing the C.Y.A. game and giving you a

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

very distorted picture.

2) Once the facts are confirmed, talk privately with the

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

individual and give them an opportunity to admit their mistake.

3) Tell the pers

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

n exactly what he or she did wrong and its impact on the organization.

4) Reaffi

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

Professional from academic institutions, pharmaceutical industries, health care indust

rm your confidence in them. After doing that, depending on the situation, pull yo

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

r team together, discuss the mistake and get their ideas on alternative solution

.

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

for future situations.

Following these simple steps will equip your staff with c

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

Companies that provide selfless information through particip

nfidence-and loyalty and those are far better results than fear and the blame game

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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Main Subject - What's in Your Culture?

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