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Answers - Resilience
I. INTRODUCTION
The term resilience, which is of frequent use in the psychotherapy area, has recently started being used in the corporate field.
In fact, this term came up in our language as a technical term, with the following meaning:
“The power that certain materials –mainly metals- have of resuming its’ original form or shape after a strong level of pressure or compression".
Obviously, this is not the concept that we are going to use all along the present article, but the one that refers to “human resistance to stress, changes and pressures and the capability of recovery”.
Within this framework, we define Human Resilience as:
“The ability and capability of certain individuals to strengthen themselves and bounce back a
The term resilience, which is of frequent use in the psychotherapy area, has recently started being used in the corporate field.
In fact, this term came up in our language as a technical term, with the following meaning:
“The power that certain materials –mainly metals- have of resuming its’ original form or shape after a strong level of pressure or compression".
Obviously, this is not the concept that we are going to use all along the present article, but the one that refers to “human resistance to stress, changes and pressures and the capability of recovery”.
Within this framework, we define Human Resilience as:
“The ability and capability of certain individuals to strengthen themselves and bounce back a
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
fter several situations of strong stress and change”.
Seen this way, there is no ethical judgment about this capability or competence, it is neither right nor ethically wrong, it exists or not and, if it doesn’t, it is really convenient to develop it.
We can also talk about Resilience in companies, which we define as: “The ability to absorb large amounts of disruptive change without a significant fall in their productivity and the ability to immediately regain its’ equilibrium”.
Recent studies have demonstrated that an individual’s resilience level –that is to say, how far has this competence been developed- is which determines his/her failure level at situations of extreme change and stress. This level is widely superior t
Seen this way, there is no ethical judgment about this capability or competence, it is neither right nor ethically wrong, it exists or not and, if it doesn’t, it is really convenient to develop it.
We can also talk about Resilience in companies, which we define as: “The ability to absorb large amounts of disruptive change without a significant fall in their productivity and the ability to immediately regain its’ equilibrium”.
Recent studies have demonstrated that an individual’s resilience level –that is to say, how far has this competence been developed- is which determines his/her failure level at situations of extreme change and stress. This level is widely superior t
; 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
o the results we may obtain, based only in education, training and experience.
Resilience has been considered and studied by several authors, from different angles. They cover as from the causes why certain people can overcome and recover from the horror of Concentration Camps, from cancer –being able to live with and cope with this illness-, as from corporate decisions, made in ambiguous and stressing environments produced by permanent changes.
However, some of these views sometimes face specific aspects in a partial way, strongly focusing on certain characteristics, which can result in a limitation to see totality. This is why several really deep studies, due to their analytical cut, center in a certain aspect, losing globa
Resilience has been considered and studied by several authors, from different angles. They cover as from the causes why certain people can overcome and recover from the horror of Concentration Camps, from cancer –being able to live with and cope with this illness-, as from corporate decisions, made in ambiguous and stressing environments produced by permanent changes.
However, some of these views sometimes face specific aspects in a partial way, strongly focusing on certain characteristics, which can result in a limitation to see totality. This is why several really deep studies, due to their analytical cut, center in a certain aspect, losing globa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
l view.
We will, therefore, try to hereby offer a systemic view to permit us visualize the parts, without losing the global view.
II. BUILDING BLOCKS
Resilience has four strong Pillars, or Building Blocks:
1) The existence of future objectives:
So as to face crisis, adversity, permanent change, stress caused by certain situations, we must have objectives and results to be obtained.
Those who are not able to view any future goal will let themselves be defeated.
Nietzche, in a famous phrase, said: “those who have something to live FOR are capable of standing almost any HOW”.
It is often said that human beings need certain degree of balance in their lives, but this is not completely true. Human beings need to face challeng
We will, therefore, try to hereby offer a systemic view to permit us visualize the parts, without losing the global view.
II. BUILDING BLOCKS
Resilience has four strong Pillars, or Building Blocks:
1) The existence of future objectives:
So as to face crisis, adversity, permanent change, stress caused by certain situations, we must have objectives and results to be obtained.
Those who are not able to view any future goal will let themselves be defeated.
Nietzche, in a famous phrase, said: “those who have something to live FOR are capable of standing almost any HOW”.
It is often said that human beings need certain degree of balance in their lives, but this is not completely true. Human beings need to face challeng
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
es for the sake of their survival, development and maturity; and the tension that is produced -between what they have achieved and what has yet to be achieved or the gap between what something is and what it should really be- is what allows them to develop their potential.
At the corporate level, this base also includes the possibility to develop the capability to visualize objectives to be achieved, however complex and ambiguous the market can be. Once this competence has been completely developed, dangerous situations start to be considered as true opportunities.
2) Facing Reality:
This second building block consists of accepting the reality of my situation and that of my company. This does not mean we are simply speaking
At the corporate level, this base also includes the possibility to develop the capability to visualize objectives to be achieved, however complex and ambiguous the market can be. Once this competence has been completely developed, dangerous situations start to be considered as true opportunities.
2) Facing Reality:
This second building block consists of accepting the reality of my situation and that of my company. This does not mean we are simply speaking
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
of an optimistic condition; optimism is always necessary, as long as it does not produce a reality distortion.
In individuals, as well as in companies, there must be a clear difference between Present, Past and Future, which are connected but, at the same time, clearly different.
Past Present Future
The existence of future objectives makes the process of facing and accepting reality easier -no matter how difficult and complex reality may seem; on the contrary, the man –the team, the company- that is not able to view any future goal will be defeated by the present time problems.
When the future disconnects itself from the present, and possible objectives are not viewed, there is a tendency to regression, to look
In individuals, as well as in companies, there must be a clear difference between Present, Past and Future, which are connected but, at the same time, clearly different.
Past Present Future
The existence of future objectives makes the process of facing and accepting reality easier -no matter how difficult and complex reality may seem; on the contrary, the man –the team, the company- that is not able to view any future goal will be defeated by the present time problems.
When the future disconnects itself from the present, and possible objectives are not viewed, there is a tendency to regression, to look
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
backwards to the past as a way to contribute to pacify the present and all its’ fears, making it seem less real. But, abandoning the present may also mean losing the meaning of life.
People who have this condition, that is to say, a certain resilience level, are realistic; they possess a clear vision of their present and especially of those parts of reality that are really important in order to live.
I understand and accept my situation today. This also happens in companies, where efforts are doubled to keep searching for niches that will enable a successful progress, instead of giving up and not fighting for survival.
3) Searching for sense:
This third column is based on the value sys
Past Future
Present
People who have this condition, that is to say, a certain resilience level, are realistic; they possess a clear vision of their present and especially of those parts of reality that are really important in order to live.
I understand and accept my situation today. This also happens in companies, where efforts are doubled to keep searching for niches that will enable a successful progress, instead of giving up and not fighting for survival.
3) Searching for sense:
This third column is based on the value sys
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
tem.
It consists of the ability to see reality and, from there, find a sense in terrible things, not considering yourself a victim: “Why is this happening to me?”, “What’s happening to my company?”, “Why is this happening?”
People who have developed the competence of resilience “create -through suffering, stress and change- positive elements that can have a meaning for themselves and the others.”
The same happens with resilient companies: they do not think “Why me?” but “Why not me, too?” and they start building values that make recovery possible.
Being able to find a meaning for things –“values”- does not mean that these values will last for ever; this circumstance carries the need of establishing a feedback process that r
It consists of the ability to see reality and, from there, find a sense in terrible things, not considering yourself a victim: “Why is this happening to me?”, “What’s happening to my company?”, “Why is this happening?”
People who have developed the competence of resilience “create -through suffering, stress and change- positive elements that can have a meaning for themselves and the others.”
The same happens with resilient companies: they do not think “Why me?” but “Why not me, too?” and they start building values that make recovery possible.
Being able to find a meaning for things –“values”- does not mean that these values will last for ever; this circumstance carries the need of establishing a feedback process that r
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
eally sustains and strengthens the permanence of the established values.
4) The ability to perform things with elements at hand:
This last column is the one that establishes the relationship between today (reality) and tomorrow (objectives) and, in serious situations of important change and/or deep crises, it enables the existence of a degree of invention capability and flexibility to improvise solutions for one or several changes, using the tools that are available at the moment. Consequently, it permits the development of the process that makes the way from “Today’s reality” to the future that shows us the new objectives of “Tomorrow” and its’ performance with the tools we already have.
III. SYSTEM THINKING AND RESILIENCE
4) The ability to perform things with elements at hand:
This last column is the one that establishes the relationship between today (reality) and tomorrow (objectives) and, in serious situations of important change and/or deep crises, it enables the existence of a degree of invention capability and flexibility to improvise solutions for one or several changes, using the tools that are available at the moment. Consequently, it permits the development of the process that makes the way from “Today’s reality” to the future that shows us the new objectives of “Tomorrow” and its’ performance with the tools we already have.
III. SYSTEM THINKING AND RESILIENCE
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
DEVELOPMENT PROCESS
Considering the process of RESILIENCE within system thinking allows us to understand not only how this process merges into the Company’s Strategy, but also which are the steps that its’ implementation will require.
This process, developed both at personal as well as corporate level, has a constant flow between TODAY’s reality and TOMORROW’s objectives, and it enables -by means of permanent feedback- the maintenance of values and its’ adjustment, in order to successfully cover the gap between the actual reality and the expected objective.
This process is constantly being adjusted through analysis and understanding of the environment that will state the speed of the adjustment to the change.
The process st
Considering the process of RESILIENCE within system thinking allows us to understand not only how this process merges into the Company’s Strategy, but also which are the steps that its’ implementation will require.
This process, developed both at personal as well as corporate level, has a constant flow between TODAY’s reality and TOMORROW’s objectives, and it enables -by means of permanent feedback- the maintenance of values and its’ adjustment, in order to successfully cover the gap between the actual reality and the expected objective.
This process is constantly being adjusted through analysis and understanding of the environment that will state the speed of the adjustment to the change.
The process st
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rts with:
A) Where we want to be -Tomorrow-: Which are the objectives we want to achieve. As Covey says, “We must start, having an objective in mind". It is essential to develop the capability to visualize the existing opportunities in an uncertain future, despite the ambiguous present.
B) How we will know we have reached that desired future: It is necessary to establish a feedback system strongly connected to our value system, which will allow us to measure the success obtained in the way towards the achievement of objectives, as well as to reinforce the Value System.
C) Where we are today: One of the main stages is to have an accurate knowledge of our reality. This will enable us to know our Strengths, Opportunities, Weakn
A) Where we want to be -Tomorrow-: Which are the objectives we want to achieve. As Covey says, “We must start, having an objective in mind". It is essential to develop the capability to visualize the existing opportunities in an uncertain future, despite the ambiguous present.
B) How we will know we have reached that desired future: It is necessary to establish a feedback system strongly connected to our value system, which will allow us to measure the success obtained in the way towards the achievement of objectives, as well as to reinforce the Value System.
C) Where we are today: One of the main stages is to have an accurate knowledge of our reality. This will enable us to know our Strengths, Opportunities, Weakn
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
esses and Threats.
D) The Process: "The ability to perform things with elements at hand ": We should plan the way that will enable us to establish an Implementation and Follow-up Model by means of a correct performance, in order to achieve the Proposed Objectives, having only the available Tools.
E) The Scenario -Environment-: It is always changing, ambiguous and complex, which obliges us to analyze it constantly, in order to make the necessary adjustments.
IV. REQUIRED ABILITIES
The process of development of the competence of resilience means having and developing certain main abilities or characteristics to its’ entire potential. These abilities, which appear at the personal level, as well as at the corporate one, mean th
D) The Process: "The ability to perform things with elements at hand ": We should plan the way that will enable us to establish an Implementation and Follow-up Model by means of a correct performance, in order to achieve the Proposed Objectives, having only the available Tools.
E) The Scenario -Environment-: It is always changing, ambiguous and complex, which obliges us to analyze it constantly, in order to make the necessary adjustments.
IV. REQUIRED ABILITIES
The process of development of the competence of resilience means having and developing certain main abilities or characteristics to its’ entire potential. These abilities, which appear at the personal level, as well as at the corporate one, mean th
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
at the individual/company is:
1. Positive: Resilient individuals (or companies) have the ability to efficiently identify opportunities in turbulent environments and simultaneously have the confidence to believe they can be successful.
2. Concentrated: Resilient individuals (or companies) have a clear vision of what they want to reach and use this objective as their personal star that will guide them whenever -at some stage of the process- they feel disoriented or uncertain.
3. Flexible: Resilient individuals (or companies) act effectively and with a wide margin in the use of both internal and external resources, developing their creativity and establishing strategies to respond to changes.
4. Organized: Resilient individual
1. Positive: Resilient individuals (or companies) have the ability to efficiently identify opportunities in turbulent environments and simultaneously have the confidence to believe they can be successful.
2. Concentrated: Resilient individuals (or companies) have a clear vision of what they want to reach and use this objective as their personal star that will guide them whenever -at some stage of the process- they feel disoriented or uncertain.
3. Flexible: Resilient individuals (or companies) act effectively and with a wide margin in the use of both internal and external resources, developing their creativity and establishing strategies to respond to changes.
4. Organized: Resilient individual
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
s (or companies) use a structured (organized) approach to handle ambiguity and thus plan and coordinate effectively the implementation of strategies.
5. Proactive: Resilient individuals (or companies) carry out actions when they face uncertainty; they adapt themselves to risks, they measure them and adjust to them, instead of looking for comfort.
6. Adaptable: The development of resilience in persons and companies is not a process of stable and linear growth. Each individual and company have their own speed for change, which is -in any of both cases- the result of their capacity to adapt themselves to new situations with minimum dysfunctional behavior.
The rhythm within which one can recover and adapt to the new scenario aft
5. Proactive: Resilient individuals (or companies) carry out actions when they face uncertainty; they adapt themselves to risks, they measure them and adjust to them, instead of looking for comfort.
6. Adaptable: The development of resilience in persons and companies is not a process of stable and linear growth. Each individual and company have their own speed for change, which is -in any of both cases- the result of their capacity to adapt themselves to new situations with minimum dysfunctional behavior.
The rhythm within which one can recover and adapt to the new scenario aft
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
er the confusion created by uncertainty will be stated by the development level of the competence of resilience; this is the most important factor to increase change speed.
The greater the development of the competence of resilience is, the faster the adjustment to new scenarios/situations and the recovery from uncertainty will take place.
V. THE ROLLERCOASTER OF CHANGE
However, if this process is not faced as a whole, if we do not observe its’ development carefully, if we do not put into practice a permanent feedback model or do not see the reality that surrounds us -which produces new changes from a critical point of view-, we could cause retreats that will affect the development of our resilience potentials.
We can draw
V. THE ROLLERCOASTER OF CHANGE
However, if this process is not faced as a whole, if we do not observe its’ development carefully, if we do not put into practice a permanent feedback model or do not see the reality that surrounds us -which produces new changes from a critical point of view-, we could cause retreats that will affect the development of our resilience potentials.
We can draw
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
his retreat possibility, the existence of peaks or valleys, using the so called Rollercoaster of Change. There we see the change cycle, which is developed throughout several stages of depression or euphoria, actives or passives, which -if correctly accompanied- end up in acceptance and commitment:
THE ROLLERCOASTER OF CHANGE
When faced, the change process, the situation ambiguity, uncertainty and stress, usually produce a shock, which ends up in immediate paralysis.
When resilience capacity has not been developed, denial takes place immediately after; the current situation, is not accepted, it is denied as if it were not a part of my reality.
The first step to a positive affirmation is accepting that the situation exists an
THE ROLLERCOASTER OF CHANGE
When faced, the change process, the situation ambiguity, uncertainty and stress, usually produce a shock, which ends up in immediate paralysis.
When resilience capacity has not been developed, denial takes place immediately after; the current situation, is not accepted, it is denied as if it were not a part of my reality.
The first step to a positive affirmation is accepting that the situation exists an
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
d that I am involved in it; this state initially causes an anger effect and then a victim feeling –“Why me?”, “What should I do?, Fall into depression?”.
As we advance in maturity and growth, we reach rationalization: we are not victims but are not part of reality either, or we do not seek to advance to the fulfillment of the objectives that will allow us to overcome the situation.
This is one of the most dangerous stages, as through rationalization we can end up in a quasi-autism condition, which will move us away from reality.
Finally, we reach the end; resilience potentials have been developed and individuals (or companies) reach acceptance and consequent commitment to face reality and move to the stage of fulfilling obje
As we advance in maturity and growth, we reach rationalization: we are not victims but are not part of reality either, or we do not seek to advance to the fulfillment of the objectives that will allow us to overcome the situation.
This is one of the most dangerous stages, as through rationalization we can end up in a quasi-autism condition, which will move us away from reality.
Finally, we reach the end; resilience potentials have been developed and individuals (or companies) reach acceptance and consequent commitment to face reality and move to the stage of fulfilling obje
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ctives.
It is only by means of an adequate coaching and a feedback model that will allow us see the real situation, that we will be able to complete the cycle effectively and prevent the fall or retreat to the previous stage.
RESILIENCE - THE HOLISTIC VISION
HOW TO IMPLEMENT THE PROCESS OF RESILIENCE DEVELOPMENT IN YOUR COMPANY
A successful implementation is not necessarily a highly complex process, but it requires its’ several parts to be correctly installed, always having the holistic vision in mind.
In order to develop it correctly, so that its’ employees and the company -as a whole- can start a growth of their resilience potentials -at the individual level as well as the corporate one- the following steps should be co
It is only by means of an adequate coaching and a feedback model that will allow us see the real situation, that we will be able to complete the cycle effectively and prevent the fall or retreat to the previous stage.
RESILIENCE - THE HOLISTIC VISION
HOW TO IMPLEMENT THE PROCESS OF RESILIENCE DEVELOPMENT IN YOUR COMPANY
A successful implementation is not necessarily a highly complex process, but it requires its’ several parts to be correctly installed, always having the holistic vision in mind.
In order to develop it correctly, so that its’ employees and the company -as a whole- can start a growth of their resilience potentials -at the individual level as well as the corporate one- the following steps should be co
.
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
nsidered:
ORGANIZATIONAL DIAGNOSIS
1) Conducting a previous meeting in order to show the whole process, its’ main stages, critical success factors, feedback system and persons to be involved.
2) Performing an adequate Organizational Diagnosis, which will make the assessment of the current reality possible.
3) Establishing and/or reaffirming the value system.
4) Defining the business’ future objectives.
5) Determining roles and responsibilities of those involved in the process’ implementation.
6) Designing the implementation and follow-up model and the corresponding tools.
IMPLEMENTATION
1) Training participants in the development of the REQUIRED ABILITIES and in the implementation of the tools which have been tailor-ma
ORGANIZATIONAL DIAGNOSIS
1) Conducting a previous meeting in order to show the whole process, its’ main stages, critical success factors, feedback system and persons to be involved.
2) Performing an adequate Organizational Diagnosis, which will make the assessment of the current reality possible.
3) Establishing and/or reaffirming the value system.
4) Defining the business’ future objectives.
5) Determining roles and responsibilities of those involved in the process’ implementation.
6) Designing the implementation and follow-up model and the corresponding tools.
IMPLEMENTATION
1) Training participants in the development of the REQUIRED ABILITIES and in the implementation of the tools which have been tailor-ma
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
de for the Organization’s needs.
2) Verifying the obtaining of feedback by assessing results and advance.
3) Analyzing alternatives and suggesting new ways, according to obtained results, keeping a permanent look on the surrounding Environment.
4) Supporting the adjustment to the new situation, when required.
5) Implementing a model of permanent support.
BIBLIOGRAPHY
* Carnegie, Dale.
* Conner, Daryl R.
* Coutu, Diane L.
* Covey, Stephen R.
* Frankl, Victor
* Gundry, L. - La Mantia, L.
* Haines, Stephen G.
* Melillo, Aldo - Su?rez Ojeda, Elbio N?stor
*Images could not be included in this format. If you would like to have the full version, please contact us at: ocastello@castello-net.com
2) Verifying the obtaining of feedback by assessing results and advance.
3) Analyzing alternatives and suggesting new ways, according to obtained results, keeping a permanent look on the surrounding Environment.
4) Supporting the adjustment to the new situation, when required.
5) Implementing a model of permanent support.
BIBLIOGRAPHY
* Carnegie, Dale.
* Conner, Daryl R.
* Coutu, Diane L.
* Covey, Stephen R.
* Frankl, Victor
* Gundry, L. - La Mantia, L.
* Haines, Stephen G.
* Melillo, Aldo - Su?rez Ojeda, Elbio N?stor
*Images could not be included in this format. If you would like to have the full version, please contact us at: ocastello@castello-net.com
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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