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There are a number of terms used in identifying the different areas of managerial process. These include leading, executing, supervising, ordering and guiding. But at the heart of the managerial process is the managerial function of directing since it is involved with initiating

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

action. This function of management will put into effect the decisions, plans and programs that have previously been worked out for achieving the goals of the group.

Directing concerns the total manner in which a manager influences actions of subordinates. First, it includes 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

ssuing orders that are clear, complete and within the capabilities of subordinates to accomplish. Assignments have to be defined to allow subordinates to think through the task, determine their level of authority, and allow them to ask questions and make recommendations. Outline

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

s must likewise be provided to be used as guides and bases for evaluation or in building checkpoints. Second, it suggests an incessant training activity in which subordinates are given instructions to enable them to carry out the particular assignment in the existing situation.

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

Remember the line that says "They haven't learned it until they can do it without you." Third, it involves the motivation of workers to meet the expectations of the manager. Let your subordinates do the job; match them to the task; focus on process as well as on product. Fourth

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

Combination pro

it consists of maintaining discipline and rewarding those who perform well. Offer specific examples, provide positive feedback, recognize individual performances, and be sincere through it all.

Briefly stated, directing is the final action of a manager in getting others to effe

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

ct all preparations toward completion. How good are the results that you get from your subordinates? These results must meet three objectives:

1) Output or production - You will require your subordinates to turn out a certain amount of work per day, per week, or per month. It

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

will be expected that this will be done on time, and therefore will meet delivery schedules and project deadlines.

2) Quality and workmanship - This means minimal or zero product defects, service errors or customer complaints.

3) Costs and budget control - Output and quality of

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

work are always restricted by the amount of money the management allows to be spent to carry them out.

Keep in mind that you, as the manager, will always be gauged by your superiors on how well you manage the various resources made available to you to accomplish your own assignme

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

nts. It follows that if you manage each of your resources well, you should get the desired results from your subordinates.

The order in which activities are directed depends upon the manager's own personal traits and the situations involved in direction. More than any other fun

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

tion, the manager will do well to act as an individual and not to try to act the way others act. In saying things, for example, watch your language. Be guided by the wise words of someone who said that "How you say it is every bit as important as what you say - sometimes more im

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

Following aspects would a

portant." Likewise, never act out of anger. Calm yourself; remove yourself; do the right thing. As a caution, remember that familiar adage that goes this way: "Anger, if not restrained, is frequently more harmful than the wrong that provoked it." As a manager, you have to sim

dd to the challenges in developing combination products:

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

ultaneously act as:

- a coach: Take responsibility, be assertive and work with them, not on them.

- a teacher: Give on-going guidance and instructions, follow day-to-day progress and provide feedback.

- a leader: Inspire, motivate and Influence your subordinates so that they

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

will strive willingly and enthusiastically toward the achievement of group goals.

A manager will be involved in various situations calling for different approaches in directing subordinates. If, for example, subordinates are unskilled and require detailed instructions, the mana

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

ger may train them. In research activity, an indulgent and advisory approach may be expedient. Ask for your subordinates' opinions.....and then listen to what they say. Take their ideas seriously; check with them before making a decision that affects them. Do not put to waste

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

ne of the most valuable resources available to you - your subordinates' good ideas. Be accessible. Listen actively; ask follow-up questions; accept bad news as well as good ones. Show that you value an opinion by listening to it, by taking it seriously, and by rewarding it for

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

Professional from academic institutions, pharmaceutical industries, health care indust

its merits. In cases of emergency, the manager may assume a "take charge" role and give short, clear authoritative commands, whereas if action is not critical, a deliberate and analytical attitude may be in order.

Different leadership types have been identified and provide a fra

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

mework for a manager in selecting an approach to directing. However, leadership styles depend upon which set of assumptions about human behavior the manager uses. Motivation must be given to the subordinates. Successful leading of subordinates results from effective motivation.

.

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

They may develop awareness of goals and a degree of confidence that they can be achieved. Proper directing or leading or supervision may not be effective unless motivation is present. Good motivation and good leadership result in success. Try to reflect on this metaphor: "Th

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

Companies that provide selfless information through particip

e keystone takes the pressure from both sides and uses this pressure to build a stronger arch. The sides can be held together only by the keystone, which strengthens, not weakens, the arch." The keystone position is the important role of supervisors and managers in organizations

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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It can be so frustrating to hear “you don’t have enough experience for the job” when you’re only 17. Sometimes employers seem to want it all their way; they want to pay minimum wage to the youngest candidate possible but they want that candidate to be experienced.

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