Digg It - Business

Recent studies have shown that industrial supervisors are working at less than 60 % of their potential. Basic management skills training is guaranteed to change all this and at such little cost

Introduction

One of the world’s most memor

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

able quotes is from Shakespeare's Hamlet - to be or not to be is all about a decision. It is a dramatic example of someone dealing with a critical decision. Freely making and executing a decision is at the very essence of human life.

Only hum

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

Examples of combination products may in

n beings have the developed capacity of assessing situations and making considered decisions, which includes evaluating the consequences of decisions before going ahead and executing them. It has been could be said that decision making is centra

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

to good management and is one of the key functions of all managers at all levels.

The 3 basic approaches

There are three basic approaches for decision making, which are:

1 Delay

This is the approach of inaction. It is amazing

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

that many people will work so hard to avoid a decision. For example, you can keep keeping the decision under constant review, passing it back and fore to your boss or simply leave it until it becomes forgotten or results in a crisis. Managers

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

Combination pro

hat use this approach often survive but they are never respected. This type of manager is a costly liability to the organization.

2 Instant decisions

This is the intuition or John Wayne / Sylvester Stallone style and it can be impressi

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

e and certainly gets results. Of course, there are times in emergencies that you need to make very fast decisions but they should never be instant. Instant decisions will:

• Use best hunches instead of rational thought powers

• Ignore potenti

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

ally damaging side effects and consequences

• Give the impression that all decisions have the same importance

3 The professional approach

The professional This approach is based on sound decision making processes using logical steps an

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

an effective thinking process. You may need you to revaluate your current methods and to change your habits but it is the only way to consistently succeed in making valid decisions and performing as an effective manager. Of course, this app

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

oach will not guarantee that you make the right decision every time but your success rate will go up dramatically. So I hope that you agree that we should reject approaches 1 and 2 and commit ourselves to the professional approach, which is al

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

o known as the rational analysis decision method making.

Attitude

Take a positive approach to decision making Don’t scowl or look disinterested when you are asked for a decision as that will hardly inspire confidence.

Don't avoid d

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

Following aspects would a

ecisions

If you demonstrate a negative approach to your team they may stop asking you for decisions and the results will be chaos. Always respond positively even if you are unable to give a final decision there and then.

Make decisions!

dd to the challenges in developing combination products:

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

/B>

Your team has the right to expect you to make decisions or they may stop asking you for them and this will result in chaos. Sometimes you have to make the decision not to make a decision. At least you have made a decision and people will

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

espect you if you have valid reasons. So use this as an effective opportunity for involving people and getting their understanding. You need to explain " why " because the decision may affect him much more than it does you.

Types of decision

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

s

There are three types of decisions that you will need to manage, which. These are: • Autocratic - you make the decision alone and accept full responsibility

• Consultative - you request help usually from your boss

• Group - you allo

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

your group to fully participate in the decision

The majority of your decisions will be autocratic but on occasions you will have need to consult someone else.

However, it is important to think about how to use the three types of decision. For

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

Professional from academic institutions, pharmaceutical industries, health care indust

example, if you consult too much your superiors will begin to wonder why they need you. On the other hand it would be foolish to make important decisions that are outside your level of expertise or have consequences that affect others outside yo

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

ur own group without some consultation. Group decisions have more limited use but it can be useful to have the input of everyone sometimes. However, the final decision must be yours so be careful that you don’t overuse this type of decision as

.

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

you must not delegate your authority to the group.

Decision before the decision

The first step is to understand what is involved in the decision and why it needs to be taken. This is often called the decision before the decision. For e

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

Companies that provide selfless information through particip

ample, you may find that someone has over reacted and that a decision is not really necessary. So you decide not to make a decision. Sounds obvious but so many managers miss this first step and get themselves into all sorts of unnecessary messes

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Digg It - Decision Making

Related Articles: