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Just Other Articles - Nine Ways to Contribute to Project Team Success
The world of work has changed. It used to be that most of us worked as a part of a process, whether on an assembly line, managing interactions with Customers, or any one of a thousand other processes. Processes are ongoing, repeatable and n
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
ever have an ending.
While there will always be some jobs and tasks which are process focused, most work now is a project or has a project component to it. Any task that has a distinct beginning and ending, or follows a specific life cycle
While there will always be some jobs and tasks which are process focused, most work now is a project or has a project component to it. Any task that has a distinct beginning and ending, or follows a specific life cycle
; 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
s a project. Examples include: planning a company meeting, writing a new brochure, implementing the new software system, etc.
If the nature of our work has changed, it is important to think about some of the skills that will help us succeed
If the nature of our work has changed, it is important to think about some of the skills that will help us succeed
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
in this different world. Here are nine ways you can contribute more effectively to make the projects you work on more successful, regardless of your specific role.
1. Understand the end goal. Since a project has a defined ending, i
1. Understand the end goal. Since a project has a defined ending, i
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
is important that each contributor to the effort knows the desired end result. Stephen Covey teaches to “begin with the end in mind.” This is clearly important to project team members. By understanding the desired result, you can make bet
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
er individual decisions and reduce confusion and re-work.
2. Identify clear roles. Each person is an important piece in the overall project puzzle. Know your role and the roles of others. If you are a project leader, take the time
2. Identify clear roles. Each person is an important piece in the overall project puzzle. Know your role and the roles of others. If you are a project leader, take the time
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
to clarify these roles for everyone. If you aren’t a leader, ask until you really understand how you can best contribute.
3. Collaborate. Project work is often fluid and free flowing. Once you understand your role and the roles of
3. Collaborate. Project work is often fluid and free flowing. Once you understand your role and the roles of
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
thers you are in a position to collaborate with them more successfully. This collaboration isn’t just a nice thing for you to do. It is imperative to the ultimate success of the project. Look for ways and be willing to collaborate.
4.
4.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Recognize interdependencies. The bigger the project, the more linked and interdependent are the people and the tasks. Certain steps need to be done before others can be completed. If you see only your small piece of the project, you ma
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
not realize how you finishing two days sooner might have a huge impact on several other things staying on track. Conversely if you fall two days behind on one of your tasks, the effects on the end results could be much longer delays. You a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
en’t an island. Your work products, decisions and efforts affect many others. Recognize and work with the interdependencies between you and the others involved in the project.
5. Ask questions. Projects can be complex. Don’t be af
5. Ask questions. Projects can be complex. Don’t be af
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
raid to ask questions to know more about any of the things mentioned above.
6. Communicate. Asking questions is communicating, but so is giving updates. Checking in with others. Coordinating schedules. If you are a project leader
6. Communicate. Asking questions is communicating, but so is giving updates. Checking in with others. Coordinating schedules. If you are a project leader
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
he importance of communication can’t be overstated. If you are any team member other than the leader, communication is just as important. You can’t leave it to the leader. Check in with others. Get their input. Find out when the pieces yo
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
u will need will be completed. Update people on your progress. Communicate!
7. Break it down. Take the big project steps and break them down into definable tasks that you can get your hands around. By breaking the tasks down the w
7. Break it down. Take the big project steps and break them down into definable tasks that you can get your hands around. By breaking the tasks down the w
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
rk won’t feel so daunting, you will find the interdependencies and you will be able to stay on track much more successfully. How do you eat an elephant? One bite at a time. Break down the overall project, and your individual steps into bit
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
sized pieces.
8. Look at the past. If a version of this project has been done in the past, look for the lessons learned to improve your results this time. Think too about other projects you have been involved in. Even if the proje
8. Look at the past. If a version of this project has been done in the past, look for the lessons learned to improve your results this time. Think too about other projects you have been involved in. Even if the proje
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
ct was smaller or larger and the goals were very different, there are likely lessons you learned that you can apply – things you did well that you would want to repeat… and things you could have done better that you can correct on this projec
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
.
9. Look to the future. Take a little time to document the best practices and ideas that work for you during the project. Whether this is a formal task for everyone on the project, or just your own notes to help you to continuously
9. Look to the future. Take a little time to document the best practices and ideas that work for you during the project. Whether this is a formal task for everyone on the project, or just your own notes to help you to continuously
.
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
improve, investing a little time now will make your contributions to all future projects more valuable and efficient.
There are many more ways you can contribute to great project success. Take these nine ideas as a starting point – as a ch
There are many more ways you can contribute to great project success. Take these nine ideas as a starting point – as a ch
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
cklist of things you can do, regardless of the role you play. Taking action on these ideas will help you feel more confident and successful in your role on the project team, and will help the project’s goals be reached much more successfully
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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