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E-Folder - Are You Managing Your Work Habits?
Have you noticed that someone else always seems to get the good assignments at work? Do you often have something to say but get drowned out by others louder and more boisterous than you? Do you find yourself being very busy but not making much progress on the things that really matter? Are you constantly struggling with missed expectations with your boss? Could you use some simple techniques to get your work life – and perhaps your life in general – on a sustained track toward long lasting
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
productivity, growth, and happiness?
So much of what makes our work life challenging is beyond our control. Yet so many of the things we could do to make our work life more enjoyable and rewarding are totally within the sphere of influence of each one of us. The good news is they don’t require anyone else to make them work for you, nor do you have to learn to use any tools you don’t already know. And you can start today! One caution however, is that you must to learn to incorporate all o
So much of what makes our work life challenging is beyond our control. Yet so many of the things we could do to make our work life more enjoyable and rewarding are totally within the sphere of influence of each one of us. The good news is they don’t require anyone else to make them work for you, nor do you have to learn to use any tools you don’t already know. And you can start today! One caution however, is that you must to learn to incorporate all o
; 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
f these ideas into your daily work habit. If they become habits, and not just a task list to throw out when complete, then you have the opportunity to realize long term benefits.
1. Be Prepared. No, not like a scout armed with tools to survive in the wilderness. Imagine you are invited to a meeting with a bunch of other people at work to discuss the Doppler project. The problem is you’ve never heard of the Doppler project and you are pretty sure none of your co-workers have either. What
1. Be Prepared. No, not like a scout armed with tools to survive in the wilderness. Imagine you are invited to a meeting with a bunch of other people at work to discuss the Doppler project. The problem is you’ve never heard of the Doppler project and you are pretty sure none of your co-workers have either. What
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
do you do? You all show up at the meeting with empty note pads and curious expressions. Then the boss explains the project and asks people in the room their opinion about how to proceed. When you are all unprepared and shooting from the hip, the loudest person often gets all the attention. But what if you did just a small bit of research before the meeting? You found out that the Doppler project had to do with a new Brazilian market expansion initiative for your company.
What if you did
What if you did
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
some more research and listed some useful facts about the Brazilian market, current distribution channels and market acceptance for your products, before the meeting? So much information is available online now that this part is easy. Keep it very simple and short – like one page - because you don’t know much more than the name and scope of the project at this point. Now you show up at that meeting and when the boss asks your opinion about how to proceed you can hand out a brief sheet of u
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
eful facts to everyone there as a basic starting point. What happens with that research? In truth, it does not matter. What matters is that you have communicated clearly to the boss and everyone else in the room that you are interested in this project and you have proactively taken steps to learn and share that learning with the team. Who wouldn’t want you on the project?
2. Be Alert. Stay tuned to new developments in your industry as they unfold in the media, or as you hear about them
2. Be Alert. Stay tuned to new developments in your industry as they unfold in the media, or as you hear about them
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
in the cafeteria, or on the golf course. Evaluate each new development in the context of your company, your job, and your customers. This helps you to be proactive in making changes and suggestions that would help the new change to be successful. Too many people keep their heads down choosing to remain oblivious of new developments going on around them. At some point they find themselves so out of step with what’s going on in their job and their company that a huge adjustment – sometimes
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
not a positive one – is needed to get them back on track.
3. Know your customer. Recognize that you have internal customers – people in your company who depend on your work, and external customers – people who pay your company for the product or service you provide. Focus first on the external customer – or the “real” customer. The one who pays the bills will have far greater influence on you and your company’s future. Every job in the company has a direct or indirect effect on your cust
3. Know your customer. Recognize that you have internal customers – people in your company who depend on your work, and external customers – people who pay your company for the product or service you provide. Focus first on the external customer – or the “real” customer. The one who pays the bills will have far greater influence on you and your company’s future. Every job in the company has a direct or indirect effect on your cust
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mers. Find out how your customers experience what you produce in your daily work. Does it make their life easier? Are they satisfied with it? Are they frustrated at having to call your hotline for help over and over again?
These issues are not simply related to the product itself. Challenging billing processes, service and support, lack of communication, and countless other issues will have as much of an effect on the customer as a poorly performing product. What specific changes can you
These issues are not simply related to the product itself. Challenging billing processes, service and support, lack of communication, and countless other issues will have as much of an effect on the customer as a poorly performing product. What specific changes can you
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
make in your work and what you produce that will benefit your customers, even in small ways? Make them and test them again.
4. Define the schedule. Often times missed expectations are the result of unclear objectives or a lack of communication about the specific work effort that will be required to accomplish a project successfully. Without any input from you, your boss will simply dictate a target date and expect you will deliver. To prevent this, you’re better off if you can create e
4. Define the schedule. Often times missed expectations are the result of unclear objectives or a lack of communication about the specific work effort that will be required to accomplish a project successfully. Without any input from you, your boss will simply dictate a target date and expect you will deliver. To prevent this, you’re better off if you can create e
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
en a simple high level outline of the key activities, deliverables, and milestones to accomplish the task. Then your boss is more likely to adjust the schedule to a date that is more realistic, and that will produce better results for everyone.
Sometimes people are afraid to appear to be questioning the orders of a demanding boss. If all you do is raise questions and produce no answers then that fear may be justified. Most demanding managers will be delighted if you come to them with a wel
Sometimes people are afraid to appear to be questioning the orders of a demanding boss. If all you do is raise questions and produce no answers then that fear may be justified. Most demanding managers will be delighted if you come to them with a wel
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
l thought out plan supported by facts to support your argument for a change in the schedule. You won’t always get your way but you’ll gain a lot of respect.
5. Share the good news. Don’t get bogged down in all the negative things that happen. Sharing good news shifts your orientation to all the great progress that’s being made and opens up new possibilities. As the bearer of good news more people will enjoy hearing from you and share good news of their own. Don’t be afraid to tell anyon
5. Share the good news. Don’t get bogged down in all the negative things that happen. Sharing good news shifts your orientation to all the great progress that’s being made and opens up new possibilities. As the bearer of good news more people will enjoy hearing from you and share good news of their own. Don’t be afraid to tell anyon
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 from top to bottom in the company about the good things that are happening, and make an effort to share any item with no less than three people. Sharing all the good news with just your office mate will do wonders for that person, but will they pass the message on? Empower yourself.
6. Include everyone on your team. People work better when they understand the context in which they are working and how what they do relates to the bigger picture. If they are all informed, then they make
6. Include everyone on your team. People work better when they understand the context in which they are working and how what they do relates to the bigger picture. If they are all informed, then they make
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
nformed decisions and produce more, faster. Avoid the tendency to share good news, best practices, tips and techniques, changes in procedures, etc., with just a few people whom you feel close to. If you can have an influence on the productivity of the entire team, you will emerge as a natural leader and you will become more productive. Why? Everyone else on the team will not only be doing a better job but they will work better with you as you will be seen as a problem solver and someone wh
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
o generously adds value to their work.
7. Ask the right questions. Focus on business outcomes. Let’s say you’re back in that meeting on the Doppler project. Often the questions people ask seem to be focused on the wrong issues, like: “Who’s in charge of the project”, or “Why wasn’t Fred invited to the meeting”, or “Can I get a free trip to Brazil”. If you ask questions about the expected business outcomes you will demonstrate that you are on board, you get it, and that you are focused on
7. Ask the right questions. Focus on business outcomes. Let’s say you’re back in that meeting on the Doppler project. Often the questions people ask seem to be focused on the wrong issues, like: “Who’s in charge of the project”, or “Why wasn’t Fred invited to the meeting”, or “Can I get a free trip to Brazil”. If you ask questions about the expected business outcomes you will demonstrate that you are on board, you get it, and that you are focused on
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
the success of the business first. People also tend to start problem solving or concluding the answer before they fully understand the problem. A little more time framing the problem and planning up front and everyone will have a better understanding. Also, people will think you’re really smart – not with answers, but with the right questions.
8. Answer the right questions. People sometimes ask a question anticipating a certain pre-conceived response. If you can clarify the question and
8. Answer the right questions. People sometimes ask a question anticipating a certain pre-conceived response. If you can clarify the question and
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
answer the correct question you will both learn, and you have steered the issue in the right direction. Also, don’t be too quick to answer all those unimportant questions that are really distractions from the business purpose. If you join in with that you will simply be seen as contributing to the confusion and not focused on the solution and results. This approach will contribute greatly to helping you sort through all the work piling up on your plate, and stay focused on the work that re
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ally matters. If you disappoint people with tasks that don’t matter while exceeding their expectations with those that are paramount, you come out far ahead.
9. Learn from your mistakes. Mistakes will happen, and often. They are valuable lessons about planning and invaluable experiences in navigating the uncertainties of the future. This can only be true if you acknowledge the mistake and take the time to learn from it so you can avoid – and help others to avoid – repeating the problem i
9. Learn from your mistakes. Mistakes will happen, and often. They are valuable lessons about planning and invaluable experiences in navigating the uncertainties of the future. This can only be true if you acknowledge the mistake and take the time to learn from it so you can avoid – and help others to avoid – repeating the problem i
.
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
the future. Come clean with the mistake, with why it happened, with what corrections have been made to avoid similar mistakes in the future, and with the person or people who experience the worst effect of the mistake. In fact, the ‘injured’ parties should be invited to help analyze the situation and provide suggestions on how to correct it. A little humility will go a long way to earning respect and trust from others.
10. Finally, make work fun. You spend most of your waking life workin
10. Finally, make work fun. You spend most of your waking life workin
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
g. You need to be productive and you need to collaborate with lots of other people. We are more innovative when we’re having fun. Keeping the mood light allows us to put problems in their proper perspective and stay focused on the solution and on the future. If you are focused on producing the best results, collaborating, sharing good news, being open and honest about mistakes, developing a deep respect for your co-workers, and tuned to the needs of your customers, you will have fun at work
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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