Main Subject - Business

Every meeting is a laboratory where you can observe and learn important things about the people who attend. In fact, you can use meetings to identify p

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

eople who merit being promoted into leadership positions. Watch for:

Is it planned?

Effective leaders always begin with clearly defined goals and the

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

Examples of combination products may in

n prepare plans for achieving them. They have the courage to set a direction and then make changes as new information becomes available. They communi

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

cate with candor knowing that people perform at their best when they know what is expected. Thus, did the person who called this meeting prepare an a

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

genda? Was the agenda distributed before the meeting? Did the agenda tell you everything that you needed to know to work effectively in the meeting?

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

Combination pro

If so, this serves as a positive indication of effective leadership planning.

Is it efficient?

A meeting is the culminating step in a larger process.

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

It begins by setting goals and preparing an agenda. Then the chairperson should have contacted key participants to inform them of their roles in the

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

meeting, told everyone how to prepare for the meeting, and alerted people who may be asked to accept responsibility for action items. All of this wo

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

rk before the meeting assures that the meeting will progress smoothly, efficiently, and effectively. So, how is the meeting going? Is there evidence

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

of this attention to detail?

Is it logical?

Pay attention to what people say during a meeting. Do their ideas contribute toward achieving the goals?

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

f so, this shows that they're working as part of a team to help find solutions. Do their ideas build upon what others just said? If so, this shows that

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

Following aspects would a

they're paying attention to the dialogue. Do their ideas demonstrate originality, creativity, and knowledge? If so, this shows they’re working hard

dd to the challenges in developing combination products:

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

to add value. Effective leaders possess strong analytical thinking skills.

Is it helpful?

Evaluate the comments and behavior during a meeting. Are th

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

e participants working to support each other? Are people contributing to the safe environment that is essential for open creative thinking? Are peopl

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

e adding high-value contributions (instead of stories or jokes that distract everyone)? Note that chronic unproductive behavior betrays either fear,

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

a lack of effective work skills, or misunderstood expectations. People who perform poorly in meetings may need constructive coaching.

Is it controll

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed?

Leadership involves more than watching people talk. Thus, observe the dynamics of the meeting process. Is the chairperson leading everybody throug

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

h methodical steps that take them to a result? Is the meeting being conducted in such a way that the participants feel that it is a fair process? Is

.

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 chairperson helping others perform at their best so that the group can produce an outstanding result?

Someone who excels in the above areas should

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

Companies that provide selfless information through particip

be considered for leadership positions. This explains why most executives consider a person’s ability to lead meetings when selecting future leaders

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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