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    Introduction

    There were two incidents, which inspired me to write this write-up, “When Expectations are not clear”. Sometime back, I had this interaction with a CEO of one of the most famous company in Bangalore, in his words, “it is impossible to give clear-cut job responsibilities and job specifications to an employee”. Second incident was an e-mail from one of my friend from Noida, stating, “Sanjeev, I expected a lot fr
    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
    om you but you failed”. Well, having expectations are important and equally important is to communicate it properly.

    Why Expectations?

    Before I start expecting anything from others, I must be clear as what I am expecting from myself. Those, who have no expectations from themselves, have no right to expect anything from others. So, just ask your self:

    - What are your expectations from yourself?

    - Where do you see yoursel
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    f in next 5-7 yrs?

    - How you wish to be remembered by your family members, your friends, your sub-ordinates and your colleagues?

    Expectations in Relations

    Imagine, if you don’t know, what are the expectations of:

    - Your parents
    - Your Children
    - Your gurus/teachers/faculties
    - Your Students
    - Your Spouse

    Your Friends, family members and people around you Don’t presume things? Don’t think that everyb
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    dy knows everything? If there are no expectations, there will be no challenge, no passion, no motivation, nothing. That is where, I mentioned, that “Silence is a crime”

    Expectations in Profession/work-place

    - How often do you appraise your employees/team-members?
    - What are your expectations from your employees/team-members?
    - What are the parameters to measure their performance?
    - Have you communicated t
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    o them?
    - What will be the consequences, if they fail?
    - What will be the rewards, if they exceed the expected level?

    If you are not having any expectations, how you are going to appraise, your employees? Yes, you are going to be biased, because you don’t have set standards. The role of a CEO, HR Manager is like a director of a movie; choreographer of a stage show, where there is a defined role for each characte
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    r, each participant.

    Setting expectations initiates the process. Managers need to sit down with each employee and clearly define what's expected of them. Management consultant, Kenneth Philips, states that when expectations are not clear, employees may not be in sync with their job's current demands and priorities. Setting expectations is not a once and done activity. Jobs change.

    Priorities change. Resources change. Mana
    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
    ers need to revise and set new expectations throughout the year. Setting expectations revolves around the following three areas:

    1. Key job responsibilities
    2. Performance factors and standards
    3. Goals

    Why is a setting expectation important? Quite simply, this process can be the cornerstone of improving the motivational climate within your sphere of responsibility. If your employees know what is expected of 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
    hem, it allows them to focus on results and to monitor themselves against the set standards. Environments in which expectations are not clear, or change from week to week, seldom create high-performing work groups.

    Three Principles that Drive Expectations

    The three principles that should drive expectations are clarity, relevance, and simplicity.

    1. Clarity

    Expectations should focus on outcomes, not activities. In other
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    words, you achieve clarity when you identify the expected results rather than the method for achieving them. Managers often make the mistake of attempting to direct the process that an employee will use rather than being clear about results. The advantage of identifying the outcome is that you, the manager, focus only on the goal; after all, the employee will develop the method for achieving the desired results.

    Defining t
    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
    e objective often requires some thought on the part of the manager because it is easy to fall into the "activities trap." While developing a strategic plan for a department or division is a worthy activity, it does not represent an outcome. In the activities trap, developing a plan is the goal, rather than increasing your market share.

    2. Relevance

    The principle of relevance helps define the "why" of the assignment. If yo
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ur employees have a full understanding of the project's importance, they can make adjustments as unanticipated factors crop up within the process. They probably also will be more committed to the result because they can see more easily how it fits into the big picture and how their efforts impact the company.

    This understanding typically is accomplished through dialogue between the manager and subordinate, which allows for
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    a more thorough review of the situation and for feedback and discussion. This process builds good will with the employee and sets the stage for additional responsibilities.

    3. Simplicity.

    Simplicity creates a sense of grounding for employees as they endeavor to carry out assignments. If managers identify the work in simple, straightforward terms, employees will find it much easier to follow through on managers' wishes. T
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    accomplish this, a manager must identify the key message in a fashion that the employee can embrace.

    Now What?

    After setting expectations, the manager should maintain a level of discipline and consistency that can be applied in all situations. The next steps involve monitoring, providing feedback, and, finally, either rewards or consequences depending on the level of achievement. This four-step model can be applied in mo
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    st managerial situations that involve goal achievement.

    1. Monitoring

    Monitoring is the follow-up that the manager provides after expectations have been set. It can take many forms, from a formal status-review meeting to a casual conversation in the hallway.

    Regardless of the form, monitoring is the component that indicates that the project or assignment is important to you as a manager and that you are keenly interested
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    in its outcome. It enables you to assess the progress and assist if unexpected roadblocks emerge.

    2. Feedback

    Feedback is the process of coaching subordinates as they complete their goals.

    During this time it is important to focus on progress, any additional resources that may be required to meet the timeline, and the subordinate's view of the project. It is key to allow employees to debrief their experience during this
    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
    phase. As the manager, you will be in a better position to evaluate not only their progress on this project, but also what future assignments they may be able to undertake.

    3. Rewards and Consequences

    The reward or consequences phase involves either positive or negative reinforcement, depending on the outcome and the process.

    Certainly, you want to reward a positive outcome. Rewards can take a number of forms, but regard
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    less of the type, they should be timely, specific, and relevant to the employee. Consequences also should be timely and specific while focusing on how the employee can improve performance. While giving negative feedback often is uncomfortable for many managers, on-the-job behavior is shaped by both circumstances and consequences. If there is no downside to poor performance, it is difficult for managers to raise the performa
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nce bar for any of their subordinates.

    This approach has the advantage of simplicity and—if consistently followed—will yield results for managers as they try to do more with less. While it may appear time-consuming at first glance, the alternatives create more rework and missed deadlines and often are far more expensive in time and resources.

    Conclusion

    Having expectations, Setting expectations is important and equally i
    .

    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
    portant is to communicate them. If you are having expectations, you are having parameters to measure those expectations, you are the judge, you appraised the person, but you failed to communicate to that person, what is the use of such expectations?

    Have expectations from your self. Have Expectations from people around you. In case of self-expectations, write it properly, and in case of having expectations from others, com
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    municate it properly. Just because, we are not having clear-cut expectations, we are having high-attrition rate at corporate level and broken families at personal level. True, I may fail. I may not be able to live up-to the level of your expectations but then I will know the margin of failure.

    Looking forward to your comments and feedback Have a great time and yes, pleaseee pleaseee do take care of your good self.

    Regards


    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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