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Advice You - PM Quick Tips - 5 Ways For PM's to Succeed
A few months back I wrote an article about a list which I had started some 10 years ago when I began managing projects. This list is a hodge-podge of things which worked and things which didn't. I've added items as years have years passed, sometimes subtracted and also updated statements to be more relative as I've grown p
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
ersonally and professionally. In that last article I focused specifically on 5 common reasons project managers fail and fall down. Today I'd like to balance that article with 5 ways to succeed. Before beginning I'd like to qualify the 5 ways I've identified.
There are quite literally hundreds if not thousands of ways to s
There are quite literally hundreds if not thousands of ways to s
; 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
ucceed as a project manager. One can look at success from general management practices, team leadership, personal competence, delivery and the entire gambit of the project processes. What I’ve aggregated here are some simple and quick tips which I hope you can carry with you as you go out into the fray to lead and direct y
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
our efforts.
Aristotle wrote “We are what we repeatedly do. Excellence then is not an act but a habit.” Much like project management we have to work to succeed and strive to achieve excellence in everything we do. Failure is easy and requires no effort on our part. Success takes work, drive, effort, motivation and dedic
Aristotle wrote “We are what we repeatedly do. Excellence then is not an act but a habit.” Much like project management we have to work to succeed and strive to achieve excellence in everything we do. Failure is easy and requires no effort on our part. Success takes work, drive, effort, motivation and dedic
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ation. After all if it was easy everybody would be just that. Successful.
1. Plan5-
In project management there are 5 “Ps” you need to stay keenly aware of; Proper Planning Prevents Pitifully Poor Performance (note this is the politically correct version). To start out right you need to create a solid plan. However,
1. Plan5-
In project management there are 5 “Ps” you need to stay keenly aware of; Proper Planning Prevents Pitifully Poor Performance (note this is the politically correct version). To start out right you need to create a solid plan. However,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
proper planning tends to be the first thing to be cast by the wayside under the pressure to deliver your project. Your plan is the roadmap on how you’re going to get to where you want to go. Take the time to develop the best plan you possibly can early on and continually refine it as the project matures. In the end you’ll
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
spend less time stumbling down the road if you know where you’re going and how you want to get there.
2. Develop Alternative Actions-
So you’ve properly planned. What’s next? Those of you who are conspiracy theorists, risk managers or who subscribe to Murphy’s Laws of Combat covet alternative action planning. Mr. Mu
2. Develop Alternative Actions-
So you’ve properly planned. What’s next? Those of you who are conspiracy theorists, risk managers or who subscribe to Murphy’s Laws of Combat covet alternative action planning. Mr. Mu
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
rphy stated the following; “No Op (operation) plan ever survives initial contact.” So be prepared for that highly detailed plan you spent so much time on developing to fall apart right before your very eyes. Nothing can be more disconcerting to a Project Manager than this. However, watch to the surprise of your sponsors a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nd envy of your peers as you reach in your back pocket and invoke your mitigation strategy or fall back plan. Then turn to them and ask “…Ok what’s next.”
3. Set up and maintain the project file-
You’ll remember this one from the 5 ways to fail. Equally so it belongs on the ways to succeed. Project administration whi
3. Set up and maintain the project file-
You’ll remember this one from the 5 ways to fail. Equally so it belongs on the ways to succeed. Project administration whi
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
le the bane of a PMs existence is a pillar for our success. Document everything (charters, scope, changes, issues, stakeholders, risks), seek buy in and confirmation on key actions and decisions in writing. Publish your information to the team and key stakeholders. Keep the file maintained in an area that’s accessible to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
all. I can’t mention how many times I’ve called upon my minutes, action logs and requirements logs to negotiate my way out of a sticky situation. Assuming you’ve documented, published and sought agreement it can save you many a big head ache. In extreme circumstances it might just save your project, perhaps even your care
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
er.
4. Be able to take criticism-
As “A” type professions go Project Management is full of them. This type of personality tends to have strong feelings about opinions. We accept all of them as long as it’s ours or agrees with ours. Most often the last thing we want to hear is criticism or thoughts alternative to what
4. Be able to take criticism-
As “A” type professions go Project Management is full of them. This type of personality tends to have strong feelings about opinions. We accept all of them as long as it’s ours or agrees with ours. Most often the last thing we want to hear is criticism or thoughts alternative to what
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
we have in mind. It’s at this point we need to stop and listen. Criticism should be seen as valuable feedback. As we grow and progress as project managers, criticism can be leveraged as a powerful tool to help read situations. It tells us how we’re presenting ourselves, how others perceive us and the results of our acti
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
ons. So the next time you find yourself on the receiving end of some negative criticism use it as a learning tool. If it’s positive criticism take note and find a way to repeat that action again.
5. Assign “I” to the Problem-
This comes down to the sometimes lost art of leadership. A good way to succeed as a Project
5. Assign “I” to the Problem-
This comes down to the sometimes lost art of leadership. A good way to succeed as a Project
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
Manager is to take ownership and accountability for the project, decisions made and the outcomes of those decisions. As a PM you’re expected to be a leader. Taking accountability will ensure a couple things. First, if it’s your fanny that’s on the line you’ll be highly motivated to ensure that what’s getting done and what’s
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
happening is going well! Second if you take accountability you’ll work hard to stay on top of the issues and plan in advance on how to resolve or avoid them all together. Important leadership note here. Always remember being accountable is more than just lip service. It also means accepting responsibility for the potential
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
failures. This is the lost art of leadership. Have you ever seen a PM who likes to call the shots but with the first sign of trouble bails? They blame the team, technology, the organization or the environment for the failures. Anybody but themselves. Remember being a leader means calling the shots, drawing fire and on occas
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ion receiving it. So go out and lead from the front and not from the rear. Lastly to note when your project succeeds don’t bask in the glory. A good leader understands while they helped get the job done they are ultimately just a servant of the team. It’s the collective outputs of the team that made the success happen. Mak
.
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
e sure they receive the lion share of the praise.
In conclusion, the above are just some highlights and I encourage you to develop lists of your own. Post it on a wall where you can see it, add to it and review it regularly. Best practices in project management come from trial, error, learning from others, capturing them a
In conclusion, the above are just some highlights and I encourage you to develop lists of your own. Post it on a wall where you can see it, add to it and review it regularly. Best practices in project management come from trial, error, learning from others, capturing them a
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
nd putting them in your respective PM tool boxes. Lastly and most importantly, after you create your list share it with others so they too can benefit from your experiences. PMI is quick to point out their view on project management is a continual journey of learning and self improvement. So go out and share your profession
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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