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    From the early times of history, any success story is accompanied by a story of empowering. Empowering is used from very early days of kings to the recent Information technology. Initially organizations were more focused on controlling that empowering. Controlling defines the process that enables the employees to have focus on their work by defining rigid process on their actions. It prevents the workforce to divert to other activities or misuse the resources in the organization. Controlling
    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
    also provides more control to the executives in organizational aspects and decision making.

    What is empowering? Empowering is the successful delegation of power. It gives the authority to take decisions. Empowering is the methodology of providing wisdom to take new roles and responsibilities. It classifies employees based on responsibilities and not on designations. It creates a workforce which works for a defined vision of the organization.

    This article provides a new perspective to leaders
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ip by emphasizing the need for empowering and the different methods used for empowering in successful organizations.

    Need for empowering

    During 70s and 80s, organizational Leaders were focused on controlling by implementing a mechanical way of execution. They defined highly streamlined job profile for each and every individual in the organization. This type of approach holds less risk and earns more accountability. In turn the employees’ turnout to be bottle necks in their fields and
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    he leaders faced challenges of sustaining internal synergy with in their groups. Since everything is controlled by strong regulation, everyone is scared to take decisions also.

    This reminds me of an incident in my team. I had to hire a part time tester for completing a pending testing work in my project. I had to convince my supervisor and he has to convince his. It went up to the level of CEO who is responsible for running the company and the final decision had to come from him. There are ar
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    und 200 projects executed under the CEO and it is outrageous for him to take such decisions for all projects.

    Modern business is highly flexible and focus started shifting towards workforce to sustain in the industry. Leaders discovered that success could be achieved by group of efficient people working in harmony. Effective empowering is the key for achieving the harmony among the workforce. Success achieved by that not only change the life of executives but also change the life of every one
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    included in the venture. A collective synergy can be achieved by this kind of execution.

    How can we empower?

    Identify individuals to be empowered. Before we start any venture, identifying the right workforce is very important. It is challenging task to identify the work force that is culturally fit for the endeavor. This is the first and foremost step for empowering. Now a days organization execute different methodologies like cultural test, behavioral interview as a part o
    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
    the recruitment. The reliable way to identify is to work with the team and sort out people who can be empowered by analyzing the basic characters like trust, commitment, skills etc.

    Build trusted relation ship After we identify the right people, next step is it to build a trusted relation ship. Trust is the readiness to take actions based on others words. Trust is a personality trait which can be cultivated with in the team. It can be cultivated by giving a conscious effort on the f
    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
    llowing activities.

    1) Treat every one with respect. 2) Build a blend of emotional and professional relation ship 4) Define a common vision for every one in the organization.

    Sincerity and integrity has lot of relevance in building that kind of relation ship. We should first show the sincerity in words and deeds. We should sincerely define an objective for your subordinates and define a clear path for their growth. We should also evaluate their growth periodically. Any endeavor shoul
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    be accompanied a vision to change the life of every one involved in that.

    Believe your companions Belief is a psychological character that is not discussed in any business management book. Trust will come only with belief. I attended a company wide meeting last year. In that meeting CEO was presenting the visions and achievements of the organization. I can find three types of people attending the group. 1. First group was giving very sarcastic comments after the speech. They thin
    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
    k that the COE is dishonest and could not be trusted. They don’t have any specific reason for those remarks, but they think that these executives are trying to deceive all employees and trying to squeeze the best out of us. I am little surprised to see that the major group are non believers.

    2. Second group is little unsatisfied with the CEO as he has not kept some of his promises for employ satisfaction.

    3. I can see a third group different from the rest of the two. I am see glitters in th
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    eyes, proud in the faces. They are looking graciously towards the CEO. They are very much impressed with the CEO and consider him the role model.

    The first groups are non believers which cannot be empowered as leaders. They always find some thing to criticize and won’t be satisfied by any remuneration. Leaders should not focus on that group.

    The second groups are intelligent group who can be empowered to the different levels. The third groups are already empowered by the CEO.

    The next ste
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    is to work with the second group. Assign mentors who can address their concerns and bring the leaders in them. A bad leader may be wrong ambassador for the venture. It may be that the second group is under a wrong leader who could not convince the right vision to the people.

    It always needs an open mind to believe people .I can strongly say that people who have achieved public victory as a leader are strong believers. As a leader of group, you cannot expect other to believe you if you can’t
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    believe them. If you do not trust any one, no one is going to trust you.

    Understand the responsibility before empowering Empowering is done to take responsibility. It may be a manager role, leader ship role or technically role. We should understand how to execute the job before we empower some one to do that. People always make a mistake of empowering someone with out knowing the details of the work they are going to do. It creates lot of misunderstanding and conflicts in the relatio
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    nship.

    Working down the hierarchy

    Most of people try to please their supervisors in the mercy of their subordinates. They squeeze the subordinate to the maximum and never allow them to grow and visible to the upper hierarchy. They are scared that the smart subordinates may replace them. They won’t be focused on building a great team but only a great reputation. This is what we call working up the hierarchy. In long term they real face will get exposed and they will be pullet out fro
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    the mainstream.

    Working down the hierarchy involves working with the team, understanding the real problems and showing the same commitment as the others in the team. You are a just a part a team who has a different responsibility. Any problems in the team are your problems and you should be with the team to fix it. A true leader is a leader who brings leaders in others. You are the spokesperson for the team and you should be the primary owner.

    Build emotional bond

    This may not be
    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
    ood advice as far as professional atmosphere is concerned. I strongly recommend building emotional bond with the team. First and foremost important thing to do is to listen your team, understand them and empathize on their problem. Most of the leaders call their subordinates to get something done from them. Always spend some time to listen your subordinates and understand their issues, whether it is personal or professional. We should also try to help them in the best possible manner and make
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    n emotional bond.

    Team Retention Real empowering will take at least 6 months. So it is necessary to retain the same team for a period of time. If they are fully empowered, they will do the work for us. We just need to provide the grease to move on and attrition will be comparatively very less. We should not allow the same team to work for a very long time also. It is a balance. It is ideal to define a metrics on how long a person need to work in a team.

    Provide sincere appreciati
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    on. It is now a trend to give appreciation for everything. People started misusing the advantage of appreciation. To get some thing done, people starts with an appreciation node. Insincere appreciation is the worse thing that you can do to anyone. It is guaranteed that one day he or she will know the fact. Before you plan to give an appreciation, ask yourself whether he deserves an appreciation. Once your team found you dishonest, it is very difficult to get back your good image.

    Pla
    .

    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
    the career for your team.

    Along with defining a vision for a venture, proper objective and vision should be defined for each and every one inside the team also. Proper objective involves defining the personal and professional achievement for the next period. Our vision should be road for fulfilling the visions of each and every one involved in the venture.

    Defining goal won’t end the story; we should evaluate periodically to make sure that they have the right focus and right spirit in
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    their commitment. This will give them right motivation to work and achieve the goals . World of Empowering

    In this dynamic work, it is very evident that success could be achieved only through effective empowering. This empowering consists of building a profession and emotional bond, so that culture, vision and success could be accomplished mutually between you and your team. It also builds a group of people working in harmony and friendship which is a long lasting asset for every one


    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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