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Advice You - Project Management - Tips on Creating a Project Culture That Ensures a Foundation for Project Succes
Although sometimes it seems that projects take on a life of their own, the simple fact is that projects don’t manage themselves. It takes the energy and commitment of a number of people to take a project from the initial idea through inception. As more companies embrace the concept of self-directed work-teams that work o
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
n specific projects, project management, will become a more vital element of the workplace. The following checklist will help you create a successful project management office:
• Formulate and outline the project
• Break up the project into manageable tasks
• Keep the project on target and complete it on time
• Formulate and outline the project
• Break up the project into manageable tasks
• Keep the project on target and complete it on time
; 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
Getting Started
The best way to guarantee a project’s success is to start with a strong foundation. Among the questions you should ask when putting together a project kick start:
• Is this something we have done before? If so, what did we learn from the last project?
• Do we have the time and resources to d
The best way to guarantee a project’s success is to start with a strong foundation. Among the questions you should ask when putting together a project kick start:
• Is this something we have done before? If so, what did we learn from the last project?
• Do we have the time and resources to d
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
this project effectively?
• How many people will we need? What sort of expertise should they have?
• Will we need to use outside sources?
• Does top management support the project?
• How long will the project take?
• Once you’ve put together a workable project plan, you need to put an action pla
• How many people will we need? What sort of expertise should they have?
• Will we need to use outside sources?
• Does top management support the project?
• How long will the project take?
• Once you’ve put together a workable project plan, you need to put an action pla
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
together so:
• Decide how many people will be assigned to the project. Assign people on the basis of their experience and expertise.
Make sure you have a commitment from upper management regarding adequate resources (funding, staff, time, etc.). Make sure, too, that you know exactly what upper management expects i
• Decide how many people will be assigned to the project. Assign people on the basis of their experience and expertise.
Make sure you have a commitment from upper management regarding adequate resources (funding, staff, time, etc.). Make sure, too, that you know exactly what upper management expects i
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the way of a given project. Communicate your interpretation of their instructions to your supervisors, and make sure you clear up any questions or confusion before the project begins.
Set up a communication network to ensure that everyone is talking with one another; don’t allow people to work in a vacuum.
Create a sc
Set up a communication network to ensure that everyone is talking with one another; don’t allow people to work in a vacuum.
Create a sc
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
hedule with specific dates by which different elements of the project will be completed. Build-in a few days to allow for unforeseen problems.
Assign someone the task of keeping records of ongoing progress during the project. This information should be shared with everyone who is working on the project.
If no one from
Assign someone the task of keeping records of ongoing progress during the project. This information should be shared with everyone who is working on the project.
If no one from
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
our division has ever worked on this sort of project, consult with people from other departments, or even from other companies (when possible) to get an idea about what to expect.
The Course of the Project
Once the project is under way, there’s a strong tendency to put it on automatic pilot. This makes it harder
The Course of the Project
Once the project is under way, there’s a strong tendency to put it on automatic pilot. This makes it harder
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
to fend off potential difficulties, and it cuts off any creative ideas that could enhance the project. Here are some ways to keep things moving effectively through the project’s duration:
Hold regular meetings. These don’t have to be formal three-hour progress sessions—but they should give project members the opp
Hold regular meetings. These don’t have to be formal three-hour progress sessions—but they should give project members the opp
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
rtunity to share ideas, voice concerns and ask questions of one another. Some of these meetings should include brainstorming sessions, which promote free flow of creative ideas.
Keep written records of meetings. These make people take the sessions more seriously, and they give anyone who’s unable to attend a poin
Keep written records of meetings. These make people take the sessions more seriously, and they give anyone who’s unable to attend a poin
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
of reference from which to work.
Have individual workers provide you with progress reports. These should not be one-sided conversations. Share your ideas, and offer to address the individuals’ concerns and answer questions as well.
Make sure deadlines are being met. Make it clear that anyone who anticipa
Have individual workers provide you with progress reports. These should not be one-sided conversations. Share your ideas, and offer to address the individuals’ concerns and answer questions as well.
Make sure deadlines are being met. Make it clear that anyone who anticipa
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
tes missing a deadline should let you know ASAP; this way, you can adjust schedules, or provide people with additional support staff or other resources.
Keep track of what is being spent on the project. Individuals should provide you with information on how much they spend. Let them know how much money they have
Keep track of what is being spent on the project. Individuals should provide you with information on how much they spend. Let them know how much money they have
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
o work with so they don’t go over budget.
If you’re working with outside contractors or people from other departments, make sure you keep them posted on the progress of the project. You should invite them to at least some of the meetings and brainstorming sessions, and be sure to solicit their opinions.
Solic
If you’re working with outside contractors or people from other departments, make sure you keep them posted on the progress of the project. You should invite them to at least some of the meetings and brainstorming sessions, and be sure to solicit their opinions.
Solic
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
t the opinions of people in the company who aren’t involved with the project. Sometimes a fresh perspective can provide the best ideas.
Keep upper management apprised of the progress you’re making. This way, you can be alerted to any potential red flags (no manager likes surprises).
The Difference Between
Keep upper management apprised of the progress you’re making. This way, you can be alerted to any potential red flags (no manager likes surprises).
The Difference Between
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
Success and Failure
A key factor in the success of the team is its leader. The qualities of a successful project leader include:
• Conscientiousness
• Technical and organizational knowledge
• Honestly/trustworthiness
• Consi
A key factor in the success of the team is its leader. The qualities of a successful project leader include:
• Conscientiousness
• Technical and organizational knowledge
• Honestly/trustworthiness
• Consi
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
tency/predictability
• Resourcefulness
When the Project Is Completed
As the project draws to a close, it’s important to remember that a completed project is not a project that is over. Here are some guidelines for dealing with the project’s completion:
Just before the project is complete, meet with the pro
• Resourcefulness
When the Project Is Completed
As the project draws to a close, it’s important to remember that a completed project is not a project that is over. Here are some guidelines for dealing with the project’s completion:
Just before the project is complete, meet with the pro
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
ject team as a whole (and one-on-one) to make sure all the loose ends are tied before the project is submitted. Make sure everyone is given credit for contributions.
Remember you don’t have to have a glitzy presentation with video and fancy hand-outs—but your presentation should be professional. Make sure you provide ne
Remember you don’t have to have a glitzy presentation with video and fancy hand-outs—but your presentation should be professional. Make sure you provide ne
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t, complete copies of your work to upper management, and make certain your presentation is well-planned and professional. A typed copy sent to the supervisor in an interoffice envelope is not enough.
Be sure to give proper recognition to team members when you present the completed project to upper management. It’s impor
Be sure to give proper recognition to team members when you present the completed project to upper management. It’s impor
.
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
ant to recognize workers in front of their peers, but they deserve recognition “upstairs” as well.
After the project is over and handed in, gather everyone who worked on it and conduct a postmortem: What were the best aspects of the project? The worst? What mistakes were made, and how can you learn from them? Did you bu
After the project is over and handed in, gather everyone who worked on it and conduct a postmortem: What were the best aspects of the project? The worst? What mistakes were made, and how can you learn from them? Did you bu
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
get, enough time and resources? Too much? Not enough? Do you need more of less outside help for the next project? Who has demonstrated expertise that had previously been ignored? How can the entire process be streamlined? Include your outside contractors and consultants in the postmortem and be sure to get their insights
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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