Main Subject - Business

Today’s workplace is very dynamic, sometimes very stressful, and too often n

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

ot very civil. We certainly observe the lack of civility in the workplace w

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

Examples of combination products may in

ith people calling each other names, engaging in personal attacks on each ot

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

her, exhibiting rude and disruptive behaviors and the lack of respect for on

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

e another or ignorance of how behaviors affect others. I believe there is a

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

Combination pro

real desire for the restoration of civility in the workplace.

Your strateg

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

ic thinking business coach offers some tips on how to achieve civility in to

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

day’s workplace.

+ Always respect the value of everyone’s time by showing

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

up for meetings prepared and on time.

+ Keep your cell phone turned off or

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

in silent or vibrate mode whenever possible.

+ Use an appropriate volume

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

of speaking when talking in the office, at meetings or on your cell phone.

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

Following aspects would a

+ Greet everyone with “hello” and a smile.

+ Avoid multi-tasking when you

dd to the challenges in developing combination products:

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

are talking on the phone or on a conference call.

+ Pay attention in meet

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

ings and do not constantly check your personal electronic devices for emails

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

, test messages, etc.

+ Respect someone’s request for a “quiet zone” or “d

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

o not disturb” time.

+ Say please, thank you and/or I am sorry.

+ Commu

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

Professional from academic institutions, pharmaceutical industries, health care indust

nicate in a professional and courteous manner in all forms and at all times

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

+ Respect all people, policies, rules and regulations.

+ Take responsibi

.

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

lity for one’s choices and actions.

+ Accept consequences of one’s inappro

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

Companies that provide selfless information through particip

priate choices and actions.

+ Demonstrate acceptable etiquette and manners

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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