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Main Subject - Read This Or One Day The MD's Presentation Could Flop Because Of You!
Musa's gets an email Monday morning from Sarah - MD's Personal Assistant. It's about the much expected presentation on a new company strategy which the MD is scheduled to deliver next Monday. Sarah's email ends with the words: "I am confident you will ensure this very important presentation goes without a hitch. Thanks in advance".
Musa Dele Anicho is Training Manager in t
Musa Dele Anicho is Training Manager in t
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
he eastern branch of a large corporate multinational. Apart from providing needs-based training for the site staff/managers, his job involves coordinating briefings/presentations etc that have a way of occurring at short notice - with the key actor often being a top man, for example in this case, Mr. Samuel Okocha, the Managing Director.
Musa grimaces as he reads the last line of
Musa grimaces as he reads the last line of
; 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
Sarah's email but seeing in it a tacit "warning" immediately sets out to make all necessary arrangements. It is the first time since becoming Training Manager that he would be personally responsible for preparations towards the MD's presentation.
By the end of the week his boss had contacted him more than 10 times about preparations and each time Musa had told him all was set. I
By the end of the week his boss had contacted him more than 10 times about preparations and each time Musa had told him all was set. I
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
deed, "as far as he could see" everything was set.
a. He had copied the PowerPoint Presentation to the Toshiba Satellite laptop supplied by the IT department and test run it over and over again - with speakers/projector.
b. He had double-checked the lighting in the Training room to be used and ensured the seating arrangement would not prevent people seeing the projector screen.
a. He had copied the PowerPoint Presentation to the Toshiba Satellite laptop supplied by the IT department and test run it over and over again - with speakers/projector.
b. He had double-checked the lighting in the Training room to be used and ensured the seating arrangement would not prevent people seeing the projector screen.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
c. Refreshments had been booked and all other routine arrangements made. All was set!
BUT why then - after all this work by Musa, did the following unfortunate event have to occur? And how did Musa via quick thinking eventually save the day - and himself?
It's 10.00 am Monday morning and Mr. Okocha(the MD) is on the 3rd slide of his presentation with all staff and Manage
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
rs in the eastern branch listening with rapt attention to the high profile presentation with serious expressions on their faces.
The MD just finished giving an overview of the new strategy and then says "Let me now move to the most important part of my presentation which is: The breakdown of our new Corporate Strategy including the Action Plan for its implementation".
He clicks
The MD just finished giving an overview of the new strategy and then says "Let me now move to the most important part of my presentation which is: The breakdown of our new Corporate Strategy including the Action Plan for its implementation".
He clicks
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
n the mouse but nothing happens(Musa's heart misses a beat). The MD clicks again, this time twice, thrice..yet still nothing happens - A frown now appears on his forehead(Musa on his part is already beginning to sweat even though the room is fully airconditioned).
The MD grunts a bit inaudibly saying "Sorry I think there's a problem" and looks around as if asking for some
The MD grunts a bit inaudibly saying "Sorry I think there's a problem" and looks around as if asking for some
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
help. Musa's boss, Mr. Lateef scowls deeply at Musa and motions with his eyes for him to do something!
Musa gets up, his mind racing, and walks with shaky legs towards the MD, who with characteristic calmness at this point casually carries on with his presentation using the printed paper version he had brought with him as a reference (Lesson: Anytime you have to give a PC pre
Musa gets up, his mind racing, and walks with shaky legs towards the MD, who with characteristic calmness at this point casually carries on with his presentation using the printed paper version he had brought with him as a reference (Lesson: Anytime you have to give a PC pre
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
sentation, endeavour to carry a printed copy (printed version) with you as a backup. Technology is reliable but not error-free: Anything can happen, so be prepared!)
He realises he must find a very quick solution that will enable the MD deliver this important information to the large audience in a way that ensures they all get a sound understanding of the subject. He forces h
He realises he must find a very quick solution that will enable the MD deliver this important information to the large audience in a way that ensures they all get a sound understanding of the subject. He forces h
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
mself to calm down and think (even as one teasing voice tells him "There goes your career down the drain -all that hard work from all those years gone!").
Musa suddenly remembers that while preparing for the MD's presentation, he had taken pains to save a backup copy of the PowerPoint Presentation on his PC desktop in his office. An idea occurs to him, and he bolts from the hall
Musa suddenly remembers that while preparing for the MD's presentation, he had taken pains to save a backup copy of the PowerPoint Presentation on his PC desktop in his office. An idea occurs to him, and he bolts from the hall
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
and up to his office in the Training block in seconds.
He tries to copy the file to a 1.44MB floppy disk, but gets an error message: "not enough disk space!" The file is 1.65MB! He curses under his breadth, checks his watch: now almost 2 minutes since the MD stopped using the PC.
Some more thinking leads him to recall that right-clicking on a file in Windows XP and highli
He tries to copy the file to a 1.44MB floppy disk, but gets an error message: "not enough disk space!" The file is 1.65MB! He curses under his breadth, checks his watch: now almost 2 minutes since the MD stopped using the PC.
Some more thinking leads him to recall that right-clicking on a file in Windows XP and highli
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
ghting the "Send To" shortcut menu item brings up a short cut menu item called "Compressed(zipped) folder". This useful feature is an alternative for when one does not have utilities like Winzip, Winrar or other file compression software on their PCs. Typically compression of up to 40% is achievable with this Windows XP version(Why not try using it now and see what you get?).
He
He
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
ight clicks the Power Point file, and applies the command. The resulting compressed .zip file easily copies to the floppy. He sprints out of his office and back into the hall where everyone turns to look at him as re-enters. He avoids his boss' glare and walks to the Laptop, heart pounding, barely hearing the MD's voice.
With the PC projector lights still switched off, he copi
With the PC projector lights still switched off, he copi
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
es the zipped file to the desktop and right clicks on it.
a. He then clicks on the "Extract All.." shortcut menu item to bring up a "Compressed (Zipped) files extraction Wizard" welcome screen.
b. He clicks "Next" twice and watches as the wizard copies a folder containing the powerpoint file to the desktop.
c. He clicks "finish" and the folder (by default setting) automatic
a. He then clicks on the "Extract All.." shortcut menu item to bring up a "Compressed (Zipped) files extraction Wizard" welcome screen.
b. He clicks "Next" twice and watches as the wizard copies a folder containing the powerpoint file to the desktop.
c. He clicks "finish" and the folder (by default setting) automatic
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
ally opens to reveal the uncompressed PowerPoint Presentation.
He quickly launches the presentation and clicks through slides 1 to 3, then holding his breath clicks to continue. There is a short delay, then the 4th slide appears! He clicks again, and the 5th appears, till all 10 slides are complete.
Musa looks up at his boss whose piercing gaze he has felt on him all the
He quickly launches the presentation and clicks through slides 1 to 3, then holding his breath clicks to continue. There is a short delay, then the 4th slide appears! He clicks again, and the 5th appears, till all 10 slides are complete.
Musa looks up at his boss whose piercing gaze he has felt on him all the
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
hile and nods to indicate all is well. He puts on the Projector lights to reveal the 4th slide at which the MD turns and says "Ah, looks like we can continue!". The presentation continues smoothly to the end. Musa looks at his watch: It had taken 3 minutes!
After the presentation, some of Musa's colleagues asked him what happened. He had no answer for them as he had checked the b
After the presentation, some of Musa's colleagues asked him what happened. He had no answer for them as he had checked the b
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
ad copy again and again and could simply not explain what had caused it to go bad or "corrupt" at the transition to slide 3. It could have been the power glitch during the test run he did - but he could not be certain.
He did tell them two things however:
a. First was that keeping a back up copy of the file on his PC(and close to the presentation venue) made it possible f
He did tell them two things however:
a. First was that keeping a back up copy of the file on his PC(and close to the presentation venue) made it possible f
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
or him to replace the bad one - in time.
b. Secondly, knowing about the Windows XP file compression utility enabled him get around the twin problems of the file being too large to fit on a disk + his not having WinZip installed on his PC.
One could argue that he could have used a Flash pen, but what if he did not own one, or could not find anyone who did or even worse(and quite
b. Secondly, knowing about the Windows XP file compression utility enabled him get around the twin problems of the file being too large to fit on a disk + his not having WinZip installed on his PC.
One could argue that he could have used a Flash pen, but what if he did not own one, or could not find anyone who did or even worse(and quite
.
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
ossible), what if the flash pen went bad or missing at that point when he needed it? Things like this have a way of happening, so one is better off considering all possibilites and preparing for them.
The most important message here is that you need to take time to acquire new/relevant knowledge and skills to enable you become more productive and efficient on your job. The
The most important message here is that you need to take time to acquire new/relevant knowledge and skills to enable you become more productive and efficient on your job. The
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
little things you can learn about technology available in your office to get more done in less time, will set you apart from the crowd and make you look good more often. The quote below, in our opinion summarises it well:
"The illiterate of the 21st Century will not be those who cannot read or write. They will be those who cannot learn, un-learn and re-learn" - Alain Tofl
"The illiterate of the 21st Century will not be those who cannot read or write. They will be those who cannot learn, un-learn and re-learn" - Alain Tofl
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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