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Does your Work Team have Posted Rules of Team Behavior? If you don’t, it could explain why your work team acts more like the crew from animal house, than your dream team pulling together and crossin

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

g the finish line to the music from Chariots of Fire.

Do you shake your head and wonder “Why can’t everyone just get along and work together?” “Why do I feel like I’m mediating and babysitting ver

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

Examples of combination products may in

es facilitating a self- directed group of business professionals?”

Management is often quick to document small procedural and operational infractions of rules in their business units, while the “wor

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

place bully” is free to roam and terrorize at large with inappropriate communication to both managers and fellow employees. The cost: much higher than any operational infraction with loss of producti

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

ity and good employees to the cancer that is “Negativity in the Workplace”.

The answer may be in the Rule Book or the absence thereof.

Consider that we are a society of rules and most

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

Combination pro

of us do try to follow them. In my Training Seminars, I tell managers it is inappropriate and in some cases actually illegal to tell an employee that “they have an attitude” even if they do have a r

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

otten one, because each of us is entitled to our own attitude.

What is critical is following what I call the CSI formula: No, don’t bring your rotten employee in for an autopsy, though some

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

assure you are sucking the life out of your organization, but do follow and document the evidence of “Unacceptable Team Behavior.”

The problem encountered in business organizations however is that

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

here is often an absence of Posted Rules of the Road for team behavior and communication. Every work team needs those rules, even family teams. Just imagine if for every couple, and in ever family,

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

there were printed rules for how we manage eventual family conflict and WE FOLLOWED THEM .

I was amazed at reading the statistical percentage (in the high 90’s) of psychologists who can predict with

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

uncanny accuracy who will be divorced and not - based on a 15 minute observations of the couple in common dialogue. In essence how they follow the rules of respectful communication, regardless of t

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

Following aspects would a

he issue was the determinant factor.

The following is a small excerpt of rules from various self-directed work teams--- Don’t copy them, but do use them as a springboard for the design of your own T

dd to the challenges in developing combination products:

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

am Rule Book. Remember, without rules; expect flagrant violations, zero enforcement and lack of team synergy.

Sample of Team Work Rules:

1. We are Solution Oriented, Not Problem Focused. W

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

en identifying any problem, we always provide at least 1 solution.

2. We seek to have all of our customers and team members feel “Trusted, Important, Special and Pleased” through respectful verbal a

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

d non-verbal communication.

3. We address any workplace conflict within 24 hours or it did not happen.

4. We look for the good in other people, recognizing if we don’t we’ll never know any good peo

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

le.

5. We refrain from destructive inner-office gossip recognizing the negative impact on our team.

6. We have fun working together and celebrate our accomplishments.

7. We begin each work-da

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

Professional from academic institutions, pharmaceutical industries, health care indust

y with a positive greeting, recognizing the first 15 minutes of the day often sets the team environment.

PS - A License to Lead:

Just as there are Rules of Team Behavior, I’m a proponent tha

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

before Leading Other people there should be a “Driver’s Road Test for New Managers and Supervisors” on the Fundamentals of Business Leadership: I’m betting we just might have some, who need to tak

.

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 test again, but in the long run, we just might have less employee accidents! All new managers ( and some not so new ) should be sent to a course or seminar on How to Manage Others . The questio

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

Companies that provide selfless information through particip

is would you put your 16 year old without training, instruction, simulation and Rules of the Road behind the driver’s seat? So why would you do that with your business. Insist on a License to Lead

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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