Advice You - Business

A stakeholder is a person who has a legitimate interest in a company or organisation. Stakehol

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

ders are usually effected by company's decisions and changes. Stakeholders influence decisions

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

Examples of combination products may in

made by company's for example, customers could recommend products and the business would take

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

action accordingly. Some Stakeholders such as Shareholders have a share in the company and wo

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

uld be interested in performance of the company to get a good return on there investment.

Exa

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

Combination pro

ples of Stakeholders

o Managing Director - The Managing director or a company or a organi

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

sation would be interested in how the business performs.

o Employees - A employee would 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

e interested in how well the company is running, they would want to know if the company was su

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

ccessful or not, if the company was not performing the employee could lose there job.

o T

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

rade Unions - A trade union would have a interest in the conditions and their financial back

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

round of the company so they can protect the employees.

o Customers - Customers would hav

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

Following aspects would a

e a interest in the company's products, price and quality not forgetting there future plans.

dd to the challenges in developing combination products:

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

o Local Community - Traffic and deliveries would effect the local community. The local com

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

munity could also be interested in future plans for the company and job vacancies.

o Comp

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

etitors - Competitors would be interested in pricing and quality to place there products accor

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

ingly. For example if Tesco's was selling milk at 39 pence Sainsburys would try to under cut T

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

Professional from academic institutions, pharmaceutical industries, health care indust

esco's so customers would go from Tesco's to Sainsburys to buy there food.

o Suppliers -

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

Suppliers would want to know if a company can afford to pay them on time. Some companies would

.

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

not want to supply certain companies for example, Gucci would not supply Marks and Spensors w

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

Companies that provide selfless information through particip

ith there products because they feel that Marks and Spensors would damage the product identity

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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