Useful Advices - Business

Many franchises run successfully with only minor problems between the franchisee and franchisor. But sometimes disputes can arise. What is the best

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

way to handle these disputes?

Most disputes arise primarily because of lack of communication. It is important to keep lines of communication open

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

Examples of combination products may in

at all times so that minor niggles are resolved easily and quickly.

The first point of call is to raise the matter verbally to the franchisor or

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

their representative. Do not make your dispute public or raise any threats at this point. Make sure you raise the matter clearly, politely and in 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

fair manner.

If this approach fails to yield a satisfactory result then it is time to put your position forward in writing direct to the franchiso

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

Combination pro

r. Again try and look at both viewpoints when writing the letter and make sure you send the correspondence by registered post.

In your letter clea

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

rly identify what the problem is, the outcome you are seeking and what you hope to achieve. Make sure you keep a copy of this letter.

It can take

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

anywhere between one and three weeks to get a written response depending on how large an organisation you are dealing with. Be patient as the griev

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

nce will have to be analysed and if possible solutions created.

If this approach fails then now is the time to write to the franchisor to look at

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

appointing a mediator to analyse the problem and find a solution. How this works will be clearly laid out in your franchise agreement. Usually both

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

parties pay half the cost of the mediator.

The mediator will look at your grievances in an unbiased manner and hopefully help to resolve the disp

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

Following aspects would a

ute in a short and timely manner. Many problems that seemed impossible to resolve have been solved very quickly once a mediator has been appointed.

dd to the challenges in developing combination products:

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

The mediator’s role is often not to dictate the solution but rather try and get the franchisee and franchisor talking so that they can reach an am

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

icable solution. If this approach does not work then the mediator might be forced to give their own judgement.

Often the mediator will ask for som

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

e payment upfront and an agreement will need to be signed that deals with how the mediation is to be handled and the relative costs of both the par

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

ties.

Each party will have to bear their own costs for travel arrangements and accommodation. The time and place of the meetings will have to agre

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

Professional from academic institutions, pharmaceutical industries, health care indust

d by the three parties concerned.

Finally if even this approach fails then the only solution left is to seek redress through the courts. This fina

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

l strategy can be extremely expensive and should only be attempted if the funds are there and the franchisee is sure of his or her case.

If the gr

.

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

ievance is not too detrimental to the running of the business then it is perhaps better to give up and resign yourself to the fact that the franchi

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

Companies that provide selfless information through particip

sor has won the argument. Bear in mind that the franchisor invariably tends to have very deep pockets and can drag on the case for a very long time

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.usefuladvices.org.ua/article/19090/usefuladvices-Franchise-Business--How-to-Resolve-Disputes-Successfully.html">Franchise Business - How to Resolve Disputes Successfully</a>

BB link (for phorums):
[url=http://www.usefuladvices.org.ua/article/19090/usefuladvices-Franchise-Business--How-to-Resolve-Disputes-Successfully.html]Franchise Business - How to Resolve Disputes Successfully[/url]

Raincoats are something which protects ourselves from many other climatic conditions other than rain. Many types of raincoats are made for different weather conditions using different fabrics and chemicals. They can be used for protection against snow falling, windcheater, for sailors and also against cold temperature.

When you use a resume, you should use one that specifically targets the job you are applying for. That may mean revising it multiple times, or creating a totally new one. But it also may mean that you get the job because you used a more effective and appropriate resume. For example...

Small Town Entrepreneurship can be profitable -- but you have to follow the written and unwritten rules.

Tags

Links

Useful Advices - Franchise Business - How to Resolve Disputes Successfully

Related Articles: