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Main Subject - When Change Is In the Wind...Heads Up!
In these days of takeovers and mergers, of downsizings and lean management, chances are that you are going to be caught in a job upheaval at least once in your career. Probably more than once!
Change in the wind may come like an invigorating breeze on a hot humid night. For instance, your boss is promoted to a new job and you have to get used
Change in the wind may come like an invigorating breeze on a hot humid night. For instance, your boss is promoted to a new job and you have to get used
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
to reporting to someone new, who turns out to be even better. But change also can come as a spark before the forest fire, when an outside takeover of your company leads to unexpected layoffs, outsourcing, and redefinition of the company itself.
But whatever the situation, once you’ve got a new job or a new boss or a new company, you must realize
But whatever the situation, once you’ve got a new job or a new boss or a new company, you must realize
; 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
you have to change. That’s survival lesson number one. The worst thing you can do is cling to the old ways of doing things or to ignore what’s happening right before your eyes. To deal effectively with change, you need to pay attention to four stages of workplace transition.
Stage 1. Something’s Up: What To Do Before The Change.
If
Stage 1. Something’s Up: What To Do Before The Change.
If
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
you’re lucky, you’ll have some advance warning and time to prepare. Sometimes you simply have the uneasy feeling that something is up. There might be lots of hushed conversations or closed-door meetings. Top management might seem especially busy and inaccessible. Or the rumor mill is running high.
If you sense something is happening, get out
If you sense something is happening, get out
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
there and keep informed. Don’t stay buried behind your desk or in your office. Be visible inside and outside your company. Just because you’re doing a good job, don’t assume you’ll be taken care of. While you’re gathering information within your own company, keep your antennae up and ears perked for news of openings in your field. Pass the 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
rd discreetly among professional colleagues that you’re thinking of trying something new. You may not need to or want to change jobs, but it’s important that you know what’s out there.
As soon as you know something definite, plan how you are going to manage yourself. The change, no matter how big or how small, will affect you personally. By ac
As soon as you know something definite, plan how you are going to manage yourself. The change, no matter how big or how small, will affect you personally. By ac
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
knowledging your feelings of anxiety, frustration or loss, you can get beyond the initial shock more quickly, start thinking more sensibly about your career options and move on.
Stage 2. Getting Acquainted: The First Couple of Months.
In the first weeks of the transition, take extra care to be visible, productive, and open to change
Stage 2. Getting Acquainted: The First Couple of Months.
In the first weeks of the transition, take extra care to be visible, productive, and open to change
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
. This is not a good time to go on vacation for two weeks. Ask yourself: Is there professional opportunity here? Or, should I now begin looking elsewhere? How can you decide whether to put your energy into making a go of it or to start letting go?
First, do more research. If there is new ownership, learn all you can about that corporate cult
First, do more research. If there is new ownership, learn all you can about that corporate cult
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ure. Study past, as well as, current reports in the business press. Ask people what it’s like to work there. If you’re used to a regimented, bureaucratic company and the new owner has an entrepreneurial approach you may be in for big changes. However, if you have a flexible, go-get-em personality, you might find it exhilarating.
If you have a
If you have a
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
new boss, find out how she was perceived in her previous job. Pick up the phone and ask around to find someone who knows her work. If it’s a restructuring, try to understand the reasons behind it. What is the company dealing with now, that it wasn’t dealing with in the past? What goals is it trying to accomplish in the reorganization? In wh
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t way can you contribute to these new goals?
Put yourself in your boss’s shoes. What are the key problems that need to be solved right now? Are you part of the problem or are you part of the solution? Are there things you could be doing right now to come out ahead of the game? If you choose to stay, it’s up to you to get on with the program,
Put yourself in your boss’s shoes. What are the key problems that need to be solved right now? Are you part of the problem or are you part of the solution? Are there things you could be doing right now to come out ahead of the game? If you choose to stay, it’s up to you to get on with the program,
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
and to show your new boss how indispensable you really are. Do it as soon as you can. If you hang back it might get harder. Take the initiative. Ask for a meeting to discuss your background, to provide an update on your projects, and to find out about the new goals for your team, department or division. You need to be perceived as adding valu
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
e not just taking up space.
Stage 3. Settled In: The Six Month Benchmark.
Now that the dust has settled, it’s the time to gauge your career health. If you’re working with a new boss or new owners or are in a totally different area, ask yourself: Do I feel like an active participant or am I on the sidelines looking in? Have I gott
Stage 3. Settled In: The Six Month Benchmark.
Now that the dust has settled, it’s the time to gauge your career health. If you’re working with a new boss or new owners or are in a totally different area, ask yourself: Do I feel like an active participant or am I on the sidelines looking in? Have I gott
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
en reassuring comments or positive feedback? If you are in the dark, take the risk and request a meeting with your boss to discuss your performance.
You need to be direct. Say, “I’ve been working hard to cooperate and adjust to the changes, but I’ve been wondering, how am I doing from your point of view? And what’s the next six months going to
You need to be direct. Say, “I’ve been working hard to cooperate and adjust to the changes, but I’ve been wondering, how am I doing from your point of view? And what’s the next six months going to
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
look like?”
You may get an indirect response such as: “You’re doing fine, keep up the hard work”; or “Let’s set a time to discuss this further.” However, don’t be satisfied with an evasive or avoidance answer. Performance feedback is essential during times of organizational transition. If all the signs are looking good, you can start breathin
You may get an indirect response such as: “You’re doing fine, keep up the hard work”; or “Let’s set a time to discuss this further.” However, don’t be satisfied with an evasive or avoidance answer. Performance feedback is essential during times of organizational transition. If all the signs are looking good, you can start breathin
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
a sign of relief. But don’t let your guard down completely. The next six months are also very important.
Stage 4. A Year After: Is The Coast Clear?
By the time you’re a year or more into a major change in your organization, it’s reasonable to wonder: Has my work life settled down at last? Am I home free? After a year, if not b
Stage 4. A Year After: Is The Coast Clear?
By the time you’re a year or more into a major change in your organization, it’s reasonable to wonder: Has my work life settled down at last? Am I home free? After a year, if not 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
efore, take time out from your normal routine and evaluate what’s been going on.
Has the sense of crisis passed? Do you see a gradual shift to a more smoothly run ship? Is your area still moving in the new direction, even if there has been an occasionally glitch? Is your new boss fitting into the company and working well with her staff and su
Has the sense of crisis passed? Do you see a gradual shift to a more smoothly run ship? Is your area still moving in the new direction, even if there has been an occasionally glitch? Is your new boss fitting into the company and working well with her staff and su
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
periors? If this is the case, great! You’ve come through the storms of change and now are going on to calmer times, at least for the short term, - long term who knows?
Or is the atmosphere still very hectic despite many attempts to try to fix what’s not working? Or, is everything on hold again for the nth time waiting for someone to make the
Or is the atmosphere still very hectic despite many attempts to try to fix what’s not working? Or, is everything on hold again for the nth time waiting for someone to make the
.
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
decision to move ahead? Or do you feel that your workload does not seem to be easing up? In fact, it’s getting worse. Sad to say, sometimes things never calm down especially in troubled industries or rapidly changing ones.
If this is your scenario, you may decide that you need a break from the relentless change. You can try to find a calmer
If this is your scenario, you may decide that you need a break from the relentless change. You can try to find a calmer
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
port within your company or you may need to seriously consider finding a new job all together. Taking control of one’s career sometimes means making some very hard decisions. But once a decision is made and action is taken, then you can get on with your life. Isn’t that what professional empowerment is all about---taking charge of one’s destiny
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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