Useful Advices - Business

So many people I worked with said they got more work done at home than in the office. That was because there were so many interruptions in the office. In fact lots of p

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

eople come in early or stay late just to have quiet time to work. One way to have that same quiet time during the day is to manage interruptions. Look for ways to creat

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

Examples of combination products may in

a “Power hour” of work time. Maybe this will allow you to get home earlier!

1. Email – shut off the audible alarm for email in your computer. Plan to check ema

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

il two or three times a day. Allot time in your schedule for answering important email. Use a good spam filter and delete unnecessary email.

2. Telephone – Use

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

oice mail message to let people know you will return their call at a particular time during the day. Let people who answer the phone for you know that you can not be int

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

Combination pro

errupted. Give them specific instructions about what constitutes and emergency.

3. Staff – Help the staff to understand the reason you cannot be interrupted. Gi

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 them a time at which they can get their questions and issues answered. Use a “Do Not Disturb” sign on your door or some other signal so that staff understands you are

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

not to be interrupted.

4. Colleagues – Use “Do Not Disturb” sign on door. Explain to colleagues that you are unreachable between certain hours. Be clear when th

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

y can talk with you. Set firm boundaries when people come in to “chat” with no clear business purpose.

5. Boss – This one is tricky. If you are working on a par

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

ticular client matter, tell the manager about your deadline and the implications if you don’t get the work done. If your deadline comes from the boss make a trade off of

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

a later deadline to accommodate the interruption.

6. Internet – Be careful about being drawn in by the Internet. Doing some research on the net can lead to distr

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

Following aspects would a

ctions like shopping or looking at interesting sites that are unrelated to your current project. The Internet can be a huge interruption while at the same time a necessi

dd to the challenges in developing combination products:

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

ty.

7. Other project – Sometimes when you are working on one project something you need to do on another pops into your head. Getting up to do the other can be a

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

way of procrastinating. If you don’t want to work on the project at hand something else that really does have to be done can be enticing. An example for me would be whe

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

n I am working on a project and suddenly realize my plants need watering. Watering the plants at that moment is a big interruption. A way to deal with it is to make a n

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

te in my calendar to do it at another time.

8. Idea Flash – Funny how you can pause to think about something you are working on and suddenly you get a great idea

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

Professional from academic institutions, pharmaceutical industries, health care indust

about something else. If you have an idea notebook write it down and move on. No special notebook? Write it down somewhere so you can come back to it once you finish.

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

9. Messy office – A messy office can drain you of energy. Make sure the place you are working is relatively clear of unessential materials before you start worki

.

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

ng. Schedule a cleaning time on your calendar.

10. Hunger, need cigarette, bathroom – Take care of these needs before you begin your work. Any one of these can

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

Companies that provide selfless information through particip

se up a whole morning because you pass other team members on your way to get food, a cigarette or to use the facilities and that can lead to conversation and distractions

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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