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Digg It - Project Management Confidence
If you have been doing project management for a while, your confidence has probably gotten an occasional shaking. And the resulting lack of confiden
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
ce hurts you, but it also hurts your team members who need you to be confident and not self-conscious. You’re their leader after all, and they want
; 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
ou to have a strong plan, vision, self-esteem and the confidence to lead.
Obsessing over our personal and organizational shortcomings traps us. We
Obsessing over our personal and organizational shortcomings traps us. We
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ay think it is for our own good – to help us truly learn from our past mistakes. But it can spiral downward into embarrassment and shame. And if you
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
find this happening to you, the best advice is to turn it around early. Take the lessons learned with you, but shed the excess baggage of self-doubt
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Sounds easy. But there certainly is not a quick fix. I have seen many project managers leave this challenging career path for non-management jobs f
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
r this reason. The fix requires having a consecutive series of successful projects to eventually construct a pillar of success.
Often it is an accu
Often it is an accu
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
ulation of shame-inducing situations that results in the loss of confidence. Maybe you have had a series of death-march projects. Set yourself up fo
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
success by getting all of these easy things down first, and then you will be in a better place to handle the harder project problems:
Keep your
Keep your
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
word. It feels good to be considered reliable. So be careful about what you commit to, but then take your commitment (even the really small ones
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
very seriously. A promise is a promise.
Be on time. Show your self-discipline to yourself and others. It’s a healthy habit that keeps you c
Be on time. Show your self-discipline to yourself and others. It’s a healthy habit that keeps you c
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
alm. Start on your way early and break the habit of always trying to squeeze in “one more thing” before leaving. It will be there when you get back
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
nd aren’t hurried.
Be honest, even when it hurts. Stick to the facts. Lying ends up being a bother and you also can get caught, leaving you
Be honest, even when it hurts. Stick to the facts. Lying ends up being a bother and you also can get caught, leaving you
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
gain with the feeling of shame. Step up to the critical conversations to say the things that are hard to tell.
Cut the gossip. If you have e
Cut the gossip. If you have e
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
er walked up to hear comments made behind your back, you know that can be hard to forgive and forget. Don’t do it to others. It give you shame even
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
f you aren’t caught. Focus on meaningful talk which will help you accomplish an aim.
Fall on the sword early. If you have bad news to tell,
Fall on the sword early. If you have bad news to tell,
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
he receiver usually appreciates hearing it sooner (when they have time to help) rather than later.
If the damage is already done and you find yours
If the damage is already done and you find yours
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lf in an embarrassing situation, you can still maintain your confidence if you find a way to recover gracefully. Sometimes this takes real creativit
.
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
, but there is almost always a way.
And finally, don’t avoid the people you made a mishap in front of – avoidance will leave you feeling further as
And finally, don’t avoid the people you made a mishap in front of – avoidance will leave you feeling further as
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
amed. The shame will wear off with faster with quick re-exposure to the people involved. So seek these people back out and re-open the communication
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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