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Advice You - Deadlines Matter, But Only If You Enforce Them
Imagine if your local newspaper didn’t show up one morning because those operating the press at the paper just didn’t make their deadlines? How would you feel? What would happen to those employees the next day? Imagine if all of the local
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
gas stations had bags over the nozzles because the deliver trucks were behind on their deadline and the pumps were empty? How would you feel?
We take for granted that some suppliers we count on always make their deadlines, so why are we n
We take for granted that some suppliers we count on always make their deadlines, so why are we n
; 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
t as expectant for our business deadlines to be met?
Routinely when working with executives reviewing strategic planning objectives, goals and targets, I hear “We’ve not got to that yet.” Over and over. Excuses often follow, and the justi
Routinely when working with executives reviewing strategic planning objectives, goals and targets, I hear “We’ve not got to that yet.” Over and over. Excuses often follow, and the justi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ications invariably are tossed around.
What happened to commitment? What happened to a deadline being a deadline? If leaders are quick to dismiss deadlines and not consider them a true end point, how will anyone else in the organization t
What happened to commitment? What happened to a deadline being a deadline? If leaders are quick to dismiss deadlines and not consider them a true end point, how will anyone else in the organization t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ake targets seriously?
Deadlines are a managerial tool that when enforced requires people to take action or deal with the consequences. One of the reasons businesses get their butts kicked is because the front office has become slack in t
Deadlines are a managerial tool that when enforced requires people to take action or deal with the consequences. One of the reasons businesses get their butts kicked is because the front office has become slack in t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
eir drive for making things happen in a timely manner.
This year for the first time in my life my tax information didn’t get in on time. My accountant called to tell me he was filing for an extension, followed by lame excuses. Did he chec
This year for the first time in my life my tax information didn’t get in on time. My accountant called to tell me he was filing for an extension, followed by lame excuses. Did he chec
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
with me first to see how I felt about this? No. Will he be my accountant after this? Not on your life. Slack attitudes toward deadlines means slack attitudes are acceptable in everything else. I have no room for those people on my team.
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
Deadlines are:
• A managerial tool to establish a date for something to be completed – no excuses.
• A target time frame to keep everyone focused on an accomplishment.
• An opportunity to separate the meaningful commitments from
• A managerial tool to establish a date for something to be completed – no excuses.
• A target time frame to keep everyone focused on an accomplishment.
• An opportunity to separate the meaningful commitments from
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
the hollow promises.
• A way to keep people challenged and moving forward.
• A method of keeping things from dragging on endlessly.
• A way to establish yourself as a leader who plays to win.
How do you know your deadline i
• A way to keep people challenged and moving forward.
• A method of keeping things from dragging on endlessly.
• A way to establish yourself as a leader who plays to win.
How do you know your deadline i
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
realistic?
Deadlines can often be set arbitrarily with a randomly selected date or with a focus of “I have to have it now” because an emergency is driving the deadline. (Said emergency is often caused by something else left undone or not
Deadlines can often be set arbitrarily with a randomly selected date or with a focus of “I have to have it now” because an emergency is driving the deadline. (Said emergency is often caused by something else left undone or not
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
on time.) Deadlines should be set with an expectation of being met. Based either on past history, or a clear understanding of exactly what is required to be accomplished, deadlines should have some input from those expected to execute it.
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
A marketing firm has a distinctive competence of magical deadlines. They can brainstorm with a company all day long and by morning have full prototype printed and ready for review by breakfast the next day. How do they do this? The team 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
sponsible for making this happen understands their hours are more night shift than day shift. They also understand that by meeting such aggressive deadlines they get to work with a company that creates buzz and can charge a premium and pay
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
premium. It’s the understanding of what can be done.
Sometimes you have to make midcourse adjustments to your deadline. The key with such adjustments is the “why” the adjustment is being made? Did you set an unrealistic deadline? Was ther
Sometimes you have to make midcourse adjustments to your deadline. The key with such adjustments is the “why” the adjustment is being made? Did you set an unrealistic deadline? Was ther
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
e a factor you forgot to include? Or, did something happen along the way to shift the target you were going after or the scope of what is being done by that deadline? Midcourse corrections because of oversights and lack of being realistic
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
o begin with could erode the respect people have for your deadlines.
If you are making changes because of now important information coming to light, or changing the scope of the project and want to set a more realistic deadline based on t
If you are making changes because of now important information coming to light, or changing the scope of the project and want to set a more realistic deadline based on t
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
e different tasks being added, then you are making savvy decisions your team will respect.
Deadlines are deadlines
Once deadlines are left to pass without any consequences, the management team soon realizes deadlines are merely suggestio
Deadlines are deadlines
Once deadlines are left to pass without any consequences, the management team soon realizes deadlines are merely suggestio
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ns and can be easily talked around. Next thing you know, opportunity is lost, laziness sets in and getting steamrolled by the competition is no longer feared – it is actually being invited – without even realizing the offer of the invitati
.
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
n; leaving executives to wonder, “How did that happen?”
Look at the deadlines you have on current projects, corrections of previous errors, and strategic initiatives and ask yourself – how seriously are these deadlines being taken? Now lo
Look at the deadlines you have on current projects, corrections of previous errors, and strategic initiatives and ask yourself – how seriously are these deadlines being taken? Now lo
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
k in the mirror and ask the hard question: Why am I letting people ignore my deadlines?
Good leaders understand how to effectively set aggressive deadlines that have reach yet are obtainable. They also understand deadlines get things done
Good leaders understand how to effectively set aggressive deadlines that have reach yet are obtainable. They also understand deadlines get things done
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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