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Strategic management is the process of specifying an organization's objectives, developing policies and plans to achieve these objectives, and allocating resources so as to implemen

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

t the plans. It is the highest level of managerial activity. It is not a task, but a rather a set of managerial skills that ought to be exerted throughout the organization, in a wi

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

Examples of combination products may in

e array of functions.

An organization’s strategy must be appropriate for its resources, environmental circumstances, and core objectives. The process involves matching the company'

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

strategic advantages to the business environment the organization faces. One objective of an overall corporate strategy is to put the organization into a position to carry out its

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

ission effectively and efficiently.

A good corporate strategy should integrate an organization’s goals, policies, and tactics into a cohesive whole, and must be based on business r

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

Combination pro

alities. Business enterprises can fail despite 'excellent' strategy because the world changes in a way they failed to understand. Strategy must connect with vision, purpose and like

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

y future trends.

Strategic management can be seen as a combination of strategy formulation and strategy implementation, but strategy must be closely aligned with purpose.

Strategy

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

formulation involves doing a situation analysis: both internal and external, both micro-environmental and macro-environmental; setting objectives—crafting vision statements (long t

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

rm view of a possible future), mission statements (the role that the organization gives itself in society), overall corporate objectives (both financial and strategic), strategic bu

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

iness unit objectives (both financial and strategic), and tactical objectives; and planning. This three-step strategy formulation process is sometimes described as determining wher

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

you are now, determining where you want to go, and then determining how to get there. These are the essence of strategic planning.

Strategy implementation involves allocation of s

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

Following aspects would a

fficient resources (financial, personnel, time, technology support); establishing a chain of command or some alternative structure (such as cross functional teams); assigning respon

dd to the challenges in developing combination products:

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

ibility of specific tasks or processes to specific individuals or groups; managing the process—monitoring results, comparing to benchmarks and best practices, evaluating the efficac

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

and efficiency of the process, controlling for variances, and making adjustments to the process as necessary. When implementing specific programs, this involves acquiring the requ

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

isite resources, developing the process, training, process testing, documentation, and integration with legacy processes.

Strategy formulation and implementation is an on-going, ne

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

er-ending, integrated process requiring continuous reassessment and reformation. Strategic management is dynamic. It involves a complex pattern of actions and reactions. It is parti

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

Professional from academic institutions, pharmaceutical industries, health care indust

lly planned and partially unplanned. Strategy is both planned and emergent, dynamic, and interactive.

For strategic management to be a success, organizations must not fail to follo

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

the plan. They should be guided by the set of objectives that they have formulated, envisioning a prosperous business. They should strive to understand customers more thoroughly.

.

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

Over-estimation of resource competence and under-estimation of time requirements should be avoided. Employee and senior management commitment should be obtained through keeping co

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

Companies that provide selfless information through particip

munication channels open and healthy. Most crucially, the management should acquire the ability to predict environmental reaction and manage change.

Copyright 2007 Ismael D. Tabij

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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In many organisations, once you have proven your abilities, the next logical step is to move into management. Is this right for you?

Are you getting tired of your part-time bookkeepers? Wouldn’t you rather focus on growing your business? Why not outsource your bookkeeping and accounting functions? Bookkeeping and taxes should not be your top priority, outsource those tasks so you can focus on growing your business.

There is no question that people can speak volumes without uttering a single word. Non-verbal communication, including body language, can be a powerful sales tool if one is able to understand its signals. However, when you realize that the human body can perform over 700,000 unique movements, the idea of comprehending all those signals would seem like an unrealistic endeavor. Do not despair because just having a rudimentary knowledge of some basic signals and gestures could greatly improve your ability to sell.

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