Useful Advices - Business

Stress plays a critical role in life. It can help you accomplish work timely and accurately, promote healthy competition, and force you to evaluat

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

e problems and formulate creative solutions. It can also hamper your ability to effectively perform your job, thereby reducing your chances of pro

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

Examples of combination products may in

motion; interfere with your capacity to sustain relationships; and lead to physical illness. So, how do you find balance? Start by preventing or

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

eliminating stress that is unnecessary.

1. Manage Expectations. Are others clear about what you expect of them? Whether they are vendors, subord

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

inates, or committee members, make sure they understand exactly what you want, and when and how you would like it completed. This will prevent mis

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

Combination pro

understandings for you as well as the other person.

2. Communicate Effectively. Many problems arise due to a lack of or ineffective communication

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

. Don’t focus solely on your verbal and written communication though. Listening is a lost art for most, and one that can stand to be improved. N

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

o matter what your position is, strong communication skills are essential.

3. Let go of control. Are you someone who thinks that no one else can

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

perform even the simplest of tasks as well as you can? If so, you could eliminate a lot of stress by simply learning to let go. Many companies re

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

organized departments into teams several years ago, because they realized that it is a more efficient and effective way to do business. It’s not n

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

ecessary for one person to perform all tasks related to his or her job. In fact, you are more effective when you concentrate on what you do best a

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

Following aspects would a

nd let someone else take care of the rest.

4. Steer Clear of Procrastination. Staying on top of things will reduce stress when the unexpected occ

dd to the challenges in developing combination products:

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

urs. Procrastination often rears its ugly head when you are faced with a task you would rather not do. Instead of putting it off, determine if it

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

would be appropriate to delegate the project or a portion of it to someone else. If not, get it out of the way first.

5. Take regular vacation t

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

ime. They give it to you for a reason. Some companies even require you to take time off. It gives you time to unwind, gain a new perspective, an

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

d become more focused. People who work too many hours without a break find themselves more prone to illness. It’s your body’s way of telling you

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

Professional from academic institutions, pharmaceutical industries, health care indust

that you need to rest.

6. Address problems as they arise. Don’t push issues to the back-burner because you don’t want to face them. Confront pro

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

blems as they arise in order to avoid stress from building up and unleashing itself at an inappropriate time.

7. You can say ‘NO’. Many people ha

.

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

ve difficulty saying no. However, you cannot take on every project, task, and role that gets cast off on you. For projects outside your scope of

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

Companies that provide selfless information through particip

responsibility, consider whether it will help you achieve your career goals. If not, politely decline the offer and move on to something that will

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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Searching for executive jobs used to be a buyer's market. Recruiters or head-hunters in the past called you with offers; companies advertised for job openings, and announcements of new positions would generate multiple interviews.

Most Americans are very concerned about the outsourcing of American corporate jobs and yet if your job has not been outsourced yet chances are you are not worried about it. But let me tell you, you should be because you quite possibly could be next.

CEO’s often call and ask me what the revenues and net profit should be before going public, they seem to think that there is a magic number that qualifies a private company into becoming a public company.

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