Main Subject - Business

I think about communication when things go wrong and often forget about sharing what is hap

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

pening in business if I am on a good road. The problem is that communication within the org

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

Examples of combination products may in

nization should be constant and not treated as an inconvenience. I am more than guilty when

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

it comes to staff meetings and I would rather duck out than face long boring talks. I tune

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

ut and think about my day rather than thinking about the company in general. By doing this,

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

Combination pro

I was finding myself out of the loop so to speak and not really knowing the underpinnings o

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

the problems the company was facing. I also was not aware of how and why we were winning b

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

usiness either. The only time I was interested is when I wanted to bring a problem to the t

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

ble and get a resolution. Does any of this sound familiar?

Somehow we need to chan

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

e the mindset of employees and make staff meetings useful and to the point. This will mean

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

reating an agenda ahead of the meeting (by at least one or two days) plus time allowances f

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

Following aspects would a

r items on that agenda. The agenda needs to be enforced by the meeting leader so that long

dd to the challenges in developing combination products:

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

iscussions are kept within a time limit. If further discussions are needed, a subsequent me

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

ting can be set to get deeper into the subject. There is no need to involve everyone in som

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

e items.

A staff meeting should address wins as well as losses plus any changes to

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

processes and results of action items from the previous meeting. This means if there was an

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

Professional from academic institutions, pharmaceutical industries, health care indust

off line discussion to resolve a problem, the resolution should be brought forward and if n

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

cessary, a vote to accept the solution.

The whole point is to direct discussions

.

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

hat keep the business going and keep the staff interested at the same time. I still dislike

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

Companies that provide selfless information through particip

staff meetings, however, I do enjoy knowing what is going on without all the boring details

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 - Who Hates Boring Meetings?

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