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In this article I will first describe and will clarify the term management. After that the political process will be depicted. The purpose of this article is to discuss the management as a part of the political process.

The Concise English Dictionary includes the definition of politics as 'prudent and

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

sagacious as well as crafty, scheming and artful'. This implies politics as having both well meaning characteristics in addition to another more sinister side. Political processes tend to take place in democracies where no single body has absolute power. To determine the best way forward groups of i

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

Examples of combination products may in

dividuals with differing views compete to have their ideas adopted as policy. The political process consists of constructive debate and argument between these groups followed by some form of voting system to identify which view has the majority support. During this process it is inevitable that other

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

forms of pressure will be brought to bear apart from just simple academic argument. For example allegiances are often formed behind the scenes on a "if you scratch my back I'll scratch yours" basis. This interpretation of a 'political process' is supported by Kakabadse in Armstrong who states that 'p

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

olitics is a process, that of influencing individuals and groups of people to your point of view, where you cannot rely on authority'. He also goes on to discuss the role of politics in organisations where he states " political behavior in an organization could be desirable or undesirable". Armstron

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

Combination pro

also points out how politics can be destructive in an organisation, mentioning behaviour such as secret meetings and hidden decisions as well as excessive and counter-productive lobbying. On the other hand he also illustrates the legitimate use of politics and presents a case where a personnel dire

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

tor set about influencing people indirectly to get a proposal accepted at a board meeting knowing there would be opposition.

With respect to management there have been many definitions put foreword over the years. Fayol in Martin whose work on management dates back to 1916, saw management as an activ

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

ity. He identified five aspects to it; planning, organising, commanding, coordinating and controlling. More recently in 1941 Follet in Sturdy states it as being 'the art of getting things done through people'. The benefits of this definition as suggested by Sturdy are that it suggests the concept o

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

management as an art by combining the idea of achieving something tangible, whilst involving the human dimension. On the other hand he also critiques this definition as he says it lacks rational techniques, does not include non human resources, the management of consumers or any political aspects to

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

management.

Child describes the definition of management as being a muddle but refers to it as having three interrelated aspects; an activity, an ideology and an elite social grouping. Here we are beginning to see evidence of a change in viewpoint of what management is thought to entail. It is perc

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

ived to be less focussed on control, although Collins states 'this does not mean that control is no longer part of management's role'.

It is not until we look at later definitions, for example by Watson, that we see a political content. He maps management as 'SAMP', Science, Art, Magic and Politics

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

Following aspects would a

. In this definition we are seeing politics as part of management activity in which he acknowledges that in order to be a successful manager an individual has to know how to "play the game" in order to achieve his objectives.

Personal experience of political process

From the above definitions of man

dd to the challenges in developing combination products:

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

gement it is clear that earlier concepts did not include any political element or take on board any human motivational factors. However more recent writers on management do clearly acknowledge a political element. Andrews records these different eras of management thinking, from scientific manageme

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

t to the more recent guru theory. Handy in his work suggests that all organisations can be mapped onto four different types of culture. These cultures still include ones of a scientific management background as well as the more modern view of guru theory. He identifies four organisational cultures, w

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

hich he labels as role, power, task and person. However by examining each of these in turn I intend to show through personal experience that political processes are taking place in each of them. In the following paragraphs I will argue that no matter which organisational culture is adopted there is

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

lways a political element to the management within the organisation.

When I first graduated I worked for Vickers Shipbuilding and Engineering Limited (VSEL). VSEL's main activity was building submarines for the nuclear deterrent. It was a very traditional British engineering company with a 'role' ori

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

Professional from academic institutions, pharmaceutical industries, health care indust

nted culture. This combination of industry sector and organisational culture matches the model of Handy , who predicts that long product life cycles and monopolies often adopt a 'role' type of culture. Having worked for the company for several months and completed my initial task, the next project w

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

as delayed for several months. In order to keep busy I suggested a temporary move to another department, where I knew they were short staffed and had a large amount of work outstanding. This suggestion however was not met with any enthusiasm by my line manager, in fact quite the opposite. It was perc

.

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

ived as a threat and I was literally shouted down with the statement that this was 'the most stupid idea and what was I thinking of'. I then spent the next few months at my desk with nothing to do spending most of my time reading the newspaper, until I finally resigned in frustration. With hindsight

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

Companies that provide selfless information through particip

I concluded that my department manager was an empire builder who wanted to maximise the size of his department for personal gain. In this instance his approach was to the detriment of the company as a whole since it was clearly resulting in large amounts of inefficiency and the loss of skilled labour

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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Listening Means Peace, Sheng jen is the Chinese word for wise person. It literally means “one who listens.” Joanna Rogers Macy, a peace activist, said listening is “the most powerful tool in peacemaking and any other kind of social change work.” I wonder what would have happened if students, teachers, and parents were really listening in Columbine? Someone, somewhere missed the distress signals that the two young killers were sending out.

Female managers are often criticized for not adhering to a hierarchical management structure within organisations and becoming too attached to individual employees. In the eyes of many traditionalists, any form of sentimentality makes poor business sense....but is attachment always bad for business?

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