Useful Advices - Business

Soon large corporate clients will be asking you if indeed you will be able to manage incase of a

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

Bird Flu Pandemic. They will want to know if indeed your company will still be around to supply

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

Examples of combination products may in

them in the event there is a Bird Flu Pandemic? What will you tell them? Are you even sure you

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

ill be around? Have you got a plan? You might wish to start thinking of one now. Meanwhile here

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

is a sample letter response you can send back in case you are blind sided by such a readiness in

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

Combination pro

uiry to such a question from a Corporate Client; Sample Response to Bird Flu Pandemic Inquiries

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

Subject: Bird Flu Pandemic Readiness

Thank you for your inquiry dated; (date) regarding our re

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

diness to handle a Bird Flu Pandemic has been considered and we have our plan in place, there fo

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

re there should be no disruptions in our services or deliver of products to your company.

We re

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

ognize the Bird Flu Pandemic is a serious issue, and have been working to correct the problem fo

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

r (amount of time). Plans are already in place and will be completed by: (will be in place by da

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

Following aspects would a

te). We are firmly committed to providing you our product(s) and service(s) without disruption c

dd to the challenges in developing combination products:

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

used by a Bird Flu Pandemic, and (have) (will have by date) people and resources in place to add

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

ress the coming of the Bird Flu Pandemic.

We (are already Bird Flu Pandemic ready) (will be Bir

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

Flu Pandemic ready ) in the following key areas of our business:

Area __________________ Date

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

Ready_________________

Example:

Business Management

Production planning

Plant operations

D

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

Professional from academic institutions, pharmaceutical industries, health care indust

stribution and Delivery

Please call us with any concerns or questions.

------- ------- -------

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

- -------- --------

This should provide you with the proper timely response to the inquiry for

.

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

our dedication to seeing the Bird Flu Pandemic thru, but you still need to develop an outline an

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

Companies that provide selfless information through particip

d a plan of how you are going to deal with all a Bird Flu Pandemic. Consider all of this in 2006

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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Money is hard to come by these days but if you have the will to really make it through then it is still very possible to make money and to make even more as each day goes by. The problem lies if you do not know where to start much more if your problem is the fact that you do not have money to begin with. How can you put up a business or invest in something when you do not have capital to begin with? Money can be found.

Networking is a productive activity. But to benefit the productivity to its full extent you should network the way you would organize other activities... ...Think for this last example about dating someone, and you communicate about mutual interests. The better the match, the more of a chance that both agree in a next step.

Vigilance is the watchword for monitoring security of the network services, as they are vulnerable to sudden attacks. Companies can set-up adequate services for detection and response but such an establishment often costs a bomb

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Useful Advices - Responding to Bird Flu Pandemic Readiness From Customers

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