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E-Folder - A Strategic Approach To Setting & Achieving Your Goals For The New Year
The end of the calendar year or the end of the company’s fiscal year presents an opportune time to review the performance of the past year and to d
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
evelop some solid business goals for the new calendar or fiscal year. Using some strategic thinking, here are a few tips for setting and achieving
; 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
your goals for the new year.
1. Use the power of “Brainstorming” by writing a list of things you'd like to accomplish. After you complete your
1. Use the power of “Brainstorming” by writing a list of things you'd like to accomplish. After you complete your
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
“brainstormed” list, prioritize and decide which things on your list are the most important.
2. Write down your goals and keep them in one central
2. Write down your goals and keep them in one central
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
place that is highly accessible and visible to you. Document any changes you make to your goals.
3. Develop goals that are challenging, yet achi
3. Develop goals that are challenging, yet achi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
evable. Be careful not to make your goals too easy or to difficult to achieve. The consequences of not following this advice is that if you make
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
them too easy, you will feel like you haven't accomplished much and if you make them too difficult, you'll feel defeated?
4. Establish realistic t
4. Establish realistic t
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
ime frames to achieve your goals. Break down each goal into specific tasks and assign yourself a due date for each task so you have a detailed pla
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n with a higher probability of success.
5. Revisit your vision statement and mission statement for your company and use those as your guide for r
5. Revisit your vision statement and mission statement for your company and use those as your guide for r
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
eviewing and selecting your goals for the new year.
Remind yourself of the motivation behind the selected goals.
6. Ensure that your goals meas
6. Ensure that your goals meas
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rable. This is critical if you want to be able to determine if you have really reached your goals.
7. Identify what resources you will need and h
7. Identify what resources you will need and h
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
ow to obtain and use those resources to achieve your goals.
8. Avoid setting yourself up to fail by setting too many goals for the new year. We
8. Avoid setting yourself up to fail by setting too many goals for the new year. We
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
tend to be driven by wanting to get everything done and to be as perfect as possible. Remember, there is a need for “balance in one’s life and tim
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 with family and for “you” is important. Set a reasonable number of goals to achieve in the new year.
9. Identify your goals as short term and l
9. Identify your goals as short term and l
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
ong term goals. Keep these lists separate. My definition of short term goals is something that can be accomplished within 1 year or less. My de
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
finition of long term goals is something that can be accomplished in more than 1 year and usually within 3 to 5 years. It is prudent to not take o
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
n too many long term goals at the same time.
10. Monitor, revise and/or update your goals as necessary. If you do extend or modify a deadline, de
10. Monitor, revise and/or update your goals as necessary. If you do extend or modify a deadline, de
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
velop a new plan on how you will meet that new time frame.? And do not forget to celebrate achieved goals.
If you would like to learn more about
If you would like to learn more about
.
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
using a strategic thinking approach to set and achieve your goals for next year and how a strategic thinking business coach can serve as your guide
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
and facilitator in that process, please contact Glenn Ebersole today through his website at www.businesscoach4u.com or by email at jgecoach@aol.co
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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