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Just Other Articles - Executives Returning To Work After Maternity Leave
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
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
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
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
Following aspects would a
do not over stretch yourself:
•Once you have to consider going back to work make sure you are completely r
•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
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
•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
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
•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
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
•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
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
•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
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
•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
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
•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
Companies that provide selfless information through particip
you are being stretched too far.
•Remember that Superwoman is a fictional character and does not exist.
•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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