Useful Advices - Business

One of the biggest challenges female executives and senior managers will face is returning to work after a brea

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

k to learn the new role of being a parent. You are just about there and have learnt the art of multi tasking a

; 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 level you had never thought was possible when a letter drops through the letter box asking when you are comi

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

ng back to work. This may be something that horrifies you or delights you and one thing is sure you will have

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

hallenges ahead. Some of these challenges will be expected, for example arranging good child care or dealing w

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

Combination pro

th the emotional side of leaving baby while you go to work. Others may not be expected for example will your bo

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

ss understand that you can no longer work long hours, will it be presumed that you are no longer serious about

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

our career because you are a mum.

How are you going to make sure that you leave the office on time to pick up

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

baby without a briefcase full of work still to be done? Think of yourself as an elastic band being pulled wi

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

er and wider. If you allow that elastic band to snap it will be useless, you may be able to put it back togeth

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

r again with a knot but it will never be the same again. So here are some tips that may help to make sure you

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

Following aspects would a

do not over stretch yourself:

•Once you have to consider going back to work make sure you are completely r

dd to the challenges in developing combination products:

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

ady.
•Give some serious thought to how you are going to balance career and family. What do you want to ac

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

hieve – what will your new life look like and feel like?
•Who can help you balance career and family and d

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

n’t be afraid to ask for help when you need it?
•Have a set of goals that will give you the life style you

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

are looking for.
•Sit down with your line manager and be clear on what he/she will expect from you going f

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

Professional from academic institutions, pharmaceutical industries, health care indust

orward and explain what you can deliver. Don’t be afraid to document this conversation in case you need to ref

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

r back to it in the future.
•If things start to get on top of you reprioritise to make sure the ‘elastic b

.

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

and’ does not snap.
•Be sure to have someone who will listen to you and support you at times when you feel

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

Companies that provide selfless information through particip

you are being stretched too far.
•Remember that Superwoman is a fictional character and does not exist.

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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Do you collect your customers email addresses? I doubt it. This is a huge mistake! Building an email list of your customers is very valuable. By staying in contact with your customers by email, or mailing to them, you build loyalty and you never let them forget you!

The main reason is to stop any potential lawsuits from happening! But do you know how many individuals I have talked to about this very thing? Many! Do you know what the majority have told me? They have locks and cameras, so they don’t need anymore security than that!

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Useful Advices - Executives Returning To Work After Maternity Leave

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