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I had never really heard the term MOU until a few months ago and now I can fathom how I can do con

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

tracts without them. A MOU (Memorandum of Understanding) will help you get working on contracts mu

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

Examples of combination products may in

ch quicker.

Here is how a MOU will work for you.

Set a meeting with a potential client.<

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

/li>

Come to an agreement with the client during the meeting.

Put the items of agre

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

ement into an MOU and have both of your sign the MOU

You now have an agreement that w

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

Combination pro

ll allow you to start doing some preliminary work without either of you backing out of the tempora

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

ry agreement. You might ask what goes into a MOU. Here are some of the items that you should consi

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

der:

The official name of each company for the terms of the agreement
The purpo

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

se of the agreement - what the general agreement is about - a summary in as few words as possible.

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

Reference information - how it relates to the agreement - date, time, or other informa

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

ion.

A clear, concise statement of the problem with any background information you feel

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

Following aspects would a

is important.

A brief description of the scope of the agreement - should be fairly spec

dd to the challenges in developing combination products:

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

ific as to what the work will be.

A list of the understandings, agreements, support and

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

resource needs plus the responsibilities of each of the parties signing the MOU.

Stat

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

e the contracting period for the MOU.

State the monetary and performance requirements -

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

do not get overly detailed as that will be spelled out in a more detailed contract later in the pr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ocess. You should also include a termination clause that benefits all parties.

State how

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

performance will be measured.

Include the date the MOU becomes effective.

.

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 final step is to have all parties sign the MOU. The MOU is one of the easiest agreement

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

Companies that provide selfless information through particip

s to put in place and help you get to work much quicker while you wait for the final contract.

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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