Subjects - Business

Successful business operations depend more and more on the professional management. It is not enough to simply produce a product; the company must produce it effectively and try to minimize the costs as much as possible.

What a manager does and how it is done can

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

be categorized by Henri Fayol's four functions of management: Planning, Organizing, Leading and Controlling. Through these functions managers can be catalysts for change or by definition change agents - "People who act as catalysts and manage the change process

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

Examples of combination products may in

" Whether performing the role of the change agent or not, change is an integral part of a manager's job. Change is "An alteration in people, structure or technology." Change occurs within and around organizations today at an unprecedented speed and complexity.

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

Change poses threats and creates opportunities. The fact that change creates opportunities is reason why managers need to encourage change.

What a manager can change falls distinctively into the three categories stated in the definition of change: people, struc

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

ure, and technology. The manager can make alterations in these areas in an attempt to adapt to or facilitate change. The change of people involves changing attitudes, expectations, perceptions and behavior. These changes are used to help people within organizat

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

Combination pro

ions to work together more effectively. Changing structure relates to job design, job specialization, hierarchy, formalization and all other organizational structural variables. These changes are ones that need to be flexible and not static to be adaptable to c

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

ange. Technological change entails modification of work processes and methods and the introduction of new equipment. Changes in this area have been enormous especially in the areas of computing and communications.

An organization's environment has both specific

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

and general components, or micro and macro environments. The organization also has its own personality or culture. This environment and culture can be the generator of forces for change. Needs from within the organization can stimulate change; these are intern

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

l forces for change. "Of course, the distinction between external and internal forces is blurred because an internally induced change may be prompted by the perception of an external event." Today's organizations are characterized by frequent disruptions to its

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

environment. New strategy, new technology and change in employee mix or attitudes are all internal factors that can create force for change.

The introduction of new equipment or technology can create the need for change within the workplace. The staff will ne

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

d to learn how to use the new equipment and it may affect the duties required of them. Their jobs may have to be redesigned. New company strategies, which may involve the change in management practices, enterprise agreements and industrial relations, will creat

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

Following aspects would a

a vast variety of needs for change. So will the attitudes of the workers. In fact employee attitudes can create the need for new company strategies in the case of job dissatisfaction, poor team spirit, lack of commitment and job insecurity.

External forces af

dd to the challenges in developing combination products:

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

fecting an organization demand change by creating threats and opportunities. The organization it compelled to respond to these threats and opportunities. These external forces are apparent in many of the segments of the organizations external environment. These

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

include political-legal, technological, economic, marketplace and sociocultural dimensions.

The political-legal environment is that which consists of government bodies, pressure groups and laws. It is pertinent for companies to keep abreast of and change in pol

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

itical environment because these changes can have dramatic effect. Change in political environment can see legislation introduced that will not make selling or providing a product feasible or somewhat difficult. There are many political factors and laws that ca

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

affect business. Pricing, competition, fair trade packaging, labeling, advertising, product safety and minimum wages can all affect business. The marketplace is a major contributor to forces for change. These forces are created by changes in customer buying ne

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

Professional from academic institutions, pharmaceutical industries, health care indust

eds, expectations and buying habits. The lifting of import tariffs or market deregulation are other factors. The technical environment is created by developments of new products or processes that affect an organizations opportunities and operations. These advan

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

ements in technology purvey benefits and impel organizations to change.

The first factor to consider for motivating change deals with whether the organization is facing some obvious need for change, such as increasing competition; pressure on prices; changing c

.

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

ustomer needs / expectations; advances in technology; reductions in external funding; or regulatory changes. The actual change does not occur until the force for change exceeds that of the force resisting the change. People who may not necessarily lose from the

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

Companies that provide selfless information through particip

change still contribute to the force resisting change. People inherently resist change because change causes uncertainty and ambiguity. Through good management these uncertainties and ambiguities will be removed and the resistance to change will not be as great

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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Chapter 2 of 3: Changing Payroll Providers Why Change Payroll Providers. What to Look for in a New Payroll Provider. What to Expect When you Change Payroll Providers.

Truth is, like it or not, you won't get far with a new career by spending your time frustrated and angry. It's time for action and only you can do it!

So what is a business strategic plan? Basically it is a combination of what you want your business to be and a roadmap to get. Here’s how to get your company focused, stable and profitable.

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