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I Advice - 9 Keys to Business Success
1. Time management: What is Important….???
Urgent vs Important
List all of your daily tasks. Label them as:
U for Urgent: They must be done very soon
N-U for Non-urgent: No pressing time problem, these may be long term situations
And also:
I for Important: They will make a difference one year from now
N-I for Non-Important: Not signific
Urgent vs Important
List all of your daily tasks. Label them as:
U for Urgent: They must be done very soon
N-U for Non-urgent: No pressing time problem, these may be long term situations
And also:
I for Important: They will make a difference one year from now
N-I for Non-Important: Not signific
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
ant to long term goals and success
If this issue is both Urgent and Important (I&U), then you need to be working on this item and getting it done.
If the issue is Urgent but not Important (N-I&U), then it can wait.
If the issue is Non-Important and Non-Urgent(N-I&N-U), it should not be on your list.
If the issue is Important but not Urgent
If this issue is both Urgent and Important (I&U), then you need to be working on this item and getting it done.
If the issue is Urgent but not Important (N-I&U), then it can wait.
If the issue is Non-Important and Non-Urgent(N-I&N-U), it should not be on your list.
If the issue is Important but not Urgent
; 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
(I&N-U), then you will need to work on it, letting only Important/Urgent issues take a higher priority.
If you have a supervisor or coach get clarification on which issues are Important and Urgent.
Determine your most productive time of day. Early AM, Mid AM, Late AM, Early PM, Mid PM, Later PM, Evening PM. Schedule your most productive times as u
If you have a supervisor or coach get clarification on which issues are Important and Urgent.
Determine your most productive time of day. Early AM, Mid AM, Late AM, Early PM, Mid PM, Later PM, Evening PM. Schedule your most productive times as u
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
n-disturbed (as possible) time for working on the Important issues, especially the Urgent/Important issues.
2. Focus: Controlling distractions and staying present
Besides managing your most productive work times, you must manage your mind’s focus.
List all distractions and, if any are important, schedule time to work of these.
Remove any v
2. Focus: Controlling distractions and staying present
Besides managing your most productive work times, you must manage your mind’s focus.
List all distractions and, if any are important, schedule time to work of these.
Remove any v
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
isual or auditory distractions from your work space, for critical/urgent work.
Limit noxious fragrances.
Get reasonably comfortable furniture with proper lighting.
Control telephone and “drop-in” distractions.
If you work at home, hopefully you can control your kids, spouse, family/friends, and pets.
Reward yourself for successful completion of
Limit noxious fragrances.
Get reasonably comfortable furniture with proper lighting.
Control telephone and “drop-in” distractions.
If you work at home, hopefully you can control your kids, spouse, family/friends, and pets.
Reward yourself for successful completion of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
major projects/issues
Do not use too much caffeine/stimulants.
3. Communication: Most important tool in business
A.) Learn to really listen (observe non-verbal cues) Do not work on your response until you understand and clarify what is being asked or stated.
B.) Ask clarifying questions
C.) Restate what you heard and get agreement on your
Do not use too much caffeine/stimulants.
3. Communication: Most important tool in business
A.) Learn to really listen (observe non-verbal cues) Do not work on your response until you understand and clarify what is being asked or stated.
B.) Ask clarifying questions
C.) Restate what you heard and get agreement on your
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
understanding of issues
D.) Set goal to accomplish positive movement on this goal/issue and get agreement from all parties. It is also good to make sure that everyone understands their role and their value to the project. Clarify the benefits and rewards for accomplishing the goal.
Speak in the First person using “I” statements… Avoid accusations
D.) Set goal to accomplish positive movement on this goal/issue and get agreement from all parties. It is also good to make sure that everyone understands their role and their value to the project. Clarify the benefits and rewards for accomplishing the goal.
Speak in the First person using “I” statements… Avoid accusations
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
or negative personal comments.
4. Leadership: Leading the horse to water…
Someone must take the lead and the responsibility for the project. A leader will bring together the required people with the talents, knowledge, and experience to create the desired successful results. Make sure that everyone understands their role in project and agree
4. Leadership: Leading the horse to water…
Someone must take the lead and the responsibility for the project. A leader will bring together the required people with the talents, knowledge, and experience to create the desired successful results. Make sure that everyone understands their role in project and agree
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s to their responsibility. A great leader will give their team room to accomplish their tasks and be open to inviting questions and offering supportive information or advice. An effective leader will role up their sleeves and help out other team members, while fulfilling their responsibilities in a timely way. Leaders set a “good” example and give 10
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
0%.
5. Managing: Your team and yourself
Good managers know what motivates the members of their team and keeps these motivations as incentives to encourage their personnel. Good managers make clear the focus or directions that they want their personnel to move. They negotiate production timelines that are reasonable and agreed upon. They crea
5. Managing: Your team and yourself
Good managers know what motivates the members of their team and keeps these motivations as incentives to encourage their personnel. Good managers make clear the focus or directions that they want their personnel to move. They negotiate production timelines that are reasonable and agreed upon. They crea
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
te a defined process for checking in on progress and help support their personnel as needed. They encourage their team in supportive ways that allow creativity and positive recognition of results.
6. Positive Mental Attitude (PMA): 'Can do…"
Projects can be difficult or even turn negative, but a PMA will often help both individuals and the t
6. Positive Mental Attitude (PMA): 'Can do…"
Projects can be difficult or even turn negative, but a PMA will often help both individuals and the t
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
eam. Breeding success with positive thoughts, actions, and comments will help to keep things moving. Focused/dwelling on the negative and what is not working should be kept to a minimum. Regular reviews of positive long term goals and affirming that the success of these goals is in process will greatly aid the process.
7. Self-care
Positive
7. Self-care
Positive
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
self-care is essential to long-term success and good quality of life. Financial success may not be enough of a reward if you’ve sacrificed your health or relationships. A balance of work and recreation needs to be found. Self-care also looks at an individual’s ability to make time for eating well, physical exercise/activity, relaxation/stress managem
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
ent, and spiritual or aesthetic development. (These self-care activities will actually save you time and energy in the long run. If you do not believe me, contact me and I will give examples, including one of an Executive Vice President I coached who found that making time for these gave him better focus, increased his productivity, and improved the
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
quality of his life.)
8. Knowledge: Training, education, experience
Life Long Learning helps to build business and personal success. An ongoing quest for knowledge not only keeps you young, it will give you greater value in the world of business. I am not just saying that you should keep up with developments in your field or profession. I am
8. Knowledge: Training, education, experience
Life Long Learning helps to build business and personal success. An ongoing quest for knowledge not only keeps you young, it will give you greater value in the world of business. I am not just saying that you should keep up with developments in your field or profession. I am
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
suggesting that you continue to broaden your education and experience in areas of investing, management development, leadership, even in entrepreneurial skills.
Keeping your mind sharp by learning new things (any new things) will keep your brain exercised, healthy, and younger. If you do not use it, you may lose it!
9. Support, Mentoring or Coa
Keeping your mind sharp by learning new things (any new things) will keep your brain exercised, healthy, and younger. If you do not use it, you may lose it!
9. Support, Mentoring or Coa
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
ching: What, Where, When, Why, Who
Make sure you know who you can turn to for coaching, mentoring or support. You also need to know when you do not know and so know when you need assistance. Mentors can support you with their past experience. Professional coaches can be objective and are paid to get you the specific information sources that you
Make sure you know who you can turn to for coaching, mentoring or support. You also need to know when you do not know and so know when you need assistance. Mentors can support you with their past experience. Professional coaches can be objective and are paid to get you the specific information sources that you
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
require. They are not doing you a favor, they are really “there” for you. Finding the “right” coach that matches your requirements can take some investigation. You can start by asking for referrals from people you know and trust, but this decision will be made by you. You will also need to ask, “are “you” coachable?” Are you willing to get the assist
.
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
ance and use it, or are you just looking for someone to tell you how smart you are? If that is what you need, then you will be wasting your time and money. If you find a coach that lets you off easy and just pats you on your back, then you may be with the wrong coach.
It requires effort and success in all 9 of these areas. If you are good at 1 or 2
It requires effort and success in all 9 of these areas. If you are good at 1 or 2
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
or 3 of these areas already, then good for you, but do not make assumptions. Keep developing in all 9 areas. If you need help or assistance in any of these areas or if you think they do not have relevance for you, then look deeper because you may be in denial and keeping yourself from your goals and success.
Along the way, take good care of yourself
Along the way, take good care of yourself
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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