Useful Advices - Business

In many organisations, once you have proven your abilities, the next logical step is to move into management. While on the face of it this might a

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

ppear sensible, it is worth consciously deciding if it is right for you. So what are the key questions to ask yourself?

1. What Do You Want?

The

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

Examples of combination products may in

obvious reply is more money. The reality is that money is rarely a huge motivator in the longer term. You might want challenging work, to make a

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

ontribution, to continually grow, to become the technical expert in your field. Will a move into management take you closer to what you want? Tak

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

the time to find out what really matters to you.

2. What Is Life Really Like As A Manager?

You can read books, articles, listen to podcasts or s

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

Combination pro

eakers that will tell you about management. What you need to know is what it is really like. Speak to those in management roles. See if you can

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

hadow some managers for a few days to see what the job is like.

3. What Skills, Knowledge and Personal Attributes Do You Need To Succeed?

Managin

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

is very different to doing. There are a whole set of skills, knowledge and attributes you need to succeed. For example:

• Influencing

• Direct

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

ng

• Taking responsibility

• Motivating

• Delegating

• Problem solving

• Project Management

Take the time to find out about the skills, knowl

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

dge and personal attributes you will need in your organisation, industry or specialism.

4. What Are You Really Great At?

Find out about yourself.

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

Assess your own strengths and get feedback from others. The idea is to get an idea of where you excel. Once you know this you can start to consi

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

Following aspects would a

er if management and you are a good fit.

5. Where Do You Struggle?

Knowing your strengths is vital. Of equal importance is understanding where y

dd to the challenges in developing combination products:

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

u struggle. Assess yourself and get feedback from others. Use this as a basis of personal development planning.

6. Do Your Strengths Greatly Exc

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

ed Your Weaknesses?

Having strong foundations to build on is essential. If you find that your strengths far outweigh your weaknesses you have exc

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

llent foundations to build on.

7. Is The Time Right?

It can be tempting to be lured by the salary increase but ask yourself is the time right to

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

ove to management. Indicators that it might be include:

• Possessing the right qualities

• Having positive feedback

• A desire for a new challe

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

Professional from academic institutions, pharmaceutical industries, health care indust

ge

• Feeling that you have achieved all that you can in a task based role

• A readiness for change

8. What Do I Need To Focus On If The Time Is

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

ot Right?

If you decide that you want to move into management eventually but not at the current time, start to put a development plan in place to:

.

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

• Build your strengths

• Work on your weaker areas

• Get you into a state of readiness

Ask for the help you need to achieve your plan and ultim

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

Companies that provide selfless information through particip

te goal.

Moving into management is a major decision. Treat it as such and you will move into it ready to embrace the challenges and opportunities

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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By understanding the two concepts of processes and resources and how best to use them, you can cause a major upgrade in your level of success.

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Useful Advices - 8 Questions To Ask Yourself Before Moving Into Management

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