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Useful Advices - It Is Not Done Yet!
You mean to tell me another time extension is needed to get this done. Haven’t you already had two extensions and increased budget for this project asks the president.
Yes we have and there have been all kinds of problems that have come up, we are not getting the support from the other departments or executives and the team is not pulling together ret
Yes we have and there have been all kinds of problems that have come up, we are not getting the support from the other departments or executives and the team is not pulling together ret
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
orts the manager.
Have you ever delegated a project and found yourself in somewhat the same situation? Many leaders do and ask what they could do differently to avoid this?
We will cover six steps that will help one delegate more effectively to the right person for the right reason and get their total buy-in to the project. The steps have been proven
Have you ever delegated a project and found yourself in somewhat the same situation? Many leaders do and ask what they could do differently to avoid this?
We will cover six steps that will help one delegate more effectively to the right person for the right reason and get their total buy-in to the project. The steps have been proven
; 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
effective by successful Fortune 100 Executives from around the world. 1..
In my last article, Frenzied Time Management we discussed six absolutes for top performance. It separated the idea of motivation from the deeper concept of willpower. Today we’ll take that idea into delegation and how to get more than just a job done, instead, let’s create a ne
In my last article, Frenzied Time Management we discussed six absolutes for top performance. It separated the idea of motivation from the deeper concept of willpower. Today we’ll take that idea into delegation and how to get more than just a job done, instead, let’s create a ne
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
leader!
6 Steps to Project Buy-in:
1. Visualize the Outcome: If we direct someone to pickup the litter on the ground and put it into the trash can, we accomplish a task. The worker may view it as a task and part of their job, but are they motivated much less inspired. On the other hand, let’s create a vision of how the grounds could look like a we
6 Steps to Project Buy-in:
1. Visualize the Outcome: If we direct someone to pickup the litter on the ground and put it into the trash can, we accomplish a task. The worker may view it as a task and part of their job, but are they motivated much less inspired. On the other hand, let’s create a vision of how the grounds could look like a we
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ll groomed park and how that will make the employee feel. Especially if they have a choice in how it is accomplished.
As we look at larger projects, new product introductions, corporate expansions or a completely new division, we may find it so huge that it is difficult to get one’s hands around it much less our minds. In these cases one needs to have
As we look at larger projects, new product introductions, corporate expansions or a completely new division, we may find it so huge that it is difficult to get one’s hands around it much less our minds. In these cases one needs to have
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 candidate break down the total vision into bite size parts so that they can start to visualize and relate to the project. The next step is combining the parts once more for a clear vision. Now the candidate can complete the next five steps.
2. Lay out the Obstacles: Far too often the hurdles and obstacles that we know will come up are glazed over
2. Lay out the Obstacles: Far too often the hurdles and obstacles that we know will come up are glazed over
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
n delegation. These later pop up on the unsuspecting candidate and immobilize some. For sure it causes delays, panic and tension.
By having the candidate take the vision in step one and layout all the obstacles they can anticipate, they have a balanced picture. They now mentally determine if they are up to the task and avoid setting themselves up fo
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
r failure.
This also helps them plan how to overcome these potential obstacles and turn them into opportunities if possible. If this sounds similar to Outcome Based Thinking, it is.
We also need to deal with the personal side of obstacles as well. What personal issues or changes might this project cause for the candidate? What will they have to chang
This also helps them plan how to overcome these potential obstacles and turn them into opportunities if possible. If this sounds similar to Outcome Based Thinking, it is.
We also need to deal with the personal side of obstacles as well. What personal issues or changes might this project cause for the candidate? What will they have to chang
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
? What will it cost them personally? What would they do instead of this project if given the choice? Why?
3. Create a Commitment: There is a difference between being motivated to do something and committed to doing something. Many managers use incentives such as trips, bonuses and awards to motivate and get results. Often these work well for the short
3. Create a Commitment: There is a difference between being motivated to do something and committed to doing something. Many managers use incentives such as trips, bonuses and awards to motivate and get results. Often these work well for the short
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
term and for a percentage of the group.
But we want long term commitment, not just short term motivation. We need the candidates head and heart into the project! So how might we do this?
We need to engage the candidate in meaningful conversation. We need to ask them to reflect on their real feelings now that they have a clear vision as well as an und
We need to engage the candidate in meaningful conversation. We need to ask them to reflect on their real feelings now that they have a clear vision as well as an und
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rstanding of the obstacles involved. Can they personally commit with their full head and heart?
I am not against incentives, yet when I talk to top performers that get most of the incentives, they indicate it was something bigger, more of a vision that drove their performance. They often looked at the incentives as the frosting, not the cake.
4. Choi
I am not against incentives, yet when I talk to top performers that get most of the incentives, they indicate it was something bigger, more of a vision that drove their performance. They often looked at the incentives as the frosting, not the cake.
4. Choi
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
ce is Needed: Far too many times I talk to frustrated people that feel they are handicapped by over policing or control from upper management. One capable young lady said, “I wish they would let me make my own mistakes so I could learn faster!” She later left the organization for a position with more responsibility and more freedom of choice.
Often d
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
legation is like child rearing. We are concerned for the child and their abilities and want to protect them from hurt or failure. We overprotect the child, over control and restrict them. Yet, how does a young toddler learn? My two and three year old grandchildren learn by experience. They climb, they try, they fall and they get up and try again. Are t
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
e people we delegate to that much different?
In the book Think and Grow Rich, a story about Andrew Carnegie talks about an executive that had just started with US Steel. He blew a project and it cost US Steel one million dollars. This is 1920 so I would guess that’s about 100 million in today’s money. He reluctantly goes to Mr. Carnegie’s office expec
In the book Think and Grow Rich, a story about Andrew Carnegie talks about an executive that had just started with US Steel. He blew a project and it cost US Steel one million dollars. This is 1920 so I would guess that’s about 100 million in today’s money. He reluctantly goes to Mr. Carnegie’s office expec
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
ting the worst. Fire you? says Mr. Carnegie, We just spent a million dollars training you! He became one of US Steels most productive executives.
Managers need to monitor, support and guide the delegation without policing or dictating. It is a balancing act.
5. Stop Loss: The delegation needs to include the ability for the candidate to determine thei
Managers need to monitor, support and guide the delegation without policing or dictating. It is a balancing act.
5. Stop Loss: The delegation needs to include the ability for the candidate to determine thei
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
own stop loss. Any choice one makes can end up being a wrong choice. How it is handled can make a tremendous difference both long and short term.
The candidate needs to determine when the project is going the wrong way prior to accepting the project. How will they terminate the project if it surpasses the stop loss point? What mechanisms both quanti
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
ative and social will act as trip levers on the project? This needs to be a self-regulated system designed and operated by the candidate.
This may be one of the more difficult points for some mangers in delegating. One needs to be willing to watch, support and advise without crushing the candidate. Remember, the previous steps will tell you if the can
This may be one of the more difficult points for some mangers in delegating. One needs to be willing to watch, support and advise without crushing the candidate. Remember, the previous steps will tell you if the can
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
didate is the right candidate and if they have bought in with both head and heart.
6. Build a Desire: A French philosopher, Antoine De SaintExupery, wrote: If you want to build a ship, don’t drum up your men to go the forest to gather wood, saw it and nail the planks together. Instead, teach them the desire for the sea. 1. What is this project real
6. Build a Desire: A French philosopher, Antoine De SaintExupery, wrote: If you want to build a ship, don’t drum up your men to go the forest to gather wood, saw it and nail the planks together. Instead, teach them the desire for the sea. 1. What is this project real
.
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
y about? How does its vision tie into the organizations objectives and culture? Can this become a mission for the candidate? Is the candidate challenged by the project?
If your candidate for the project is still saying yes and is stomping like a thoroughbred race horse, you have the right person. Like a pro jockey, let the horse run, just support and
If your candidate for the project is still saying yes and is stomping like a thoroughbred race horse, you have the right person. Like a pro jockey, let the horse run, just support and
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
uide them around the track.
For more on management development, sales, customer service or personal development check out our web site at www.BusArc.com or www.Hgoergerassoc.com
References:
1. Heike Bruch – Sumantra Ghoshal, A Bias for Actio
For more on management development, sales, customer service or personal development check out our web site at www.BusArc.com or www.Hgoergerassoc.com
References:
1. Heike Bruch – Sumantra Ghoshal, A Bias for Actio
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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