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  • Main Subject - Five Rules for Negotiating Like A Pro

    No matter whether you are negotiating a raise with your boss, negotiating a vacation schedule with you ex-spouse or negotiating with a seller or buyer on an on-line auction, there are certain rules or principles that will help you set
    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
    tle your disputes. These five Rules will help you resolve your dispute and negotiate like a Pro.

    Rule 1 Focus on the goal. Don’t be distracted by your emotions.

    It is important to check your emotions at the door before trying to neg
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    otiate anything. Emotions such as anger can make one lose control. We have all seen someone who gets red in the face and starts shaking his finger and generally looks as though he could easily have a heart attack. Sometimes that perso
    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 is so mad that he is incoherent. You need to get past that stage if you are going to succeed.

    If you are the one who is angry and upset, you need to focus on what you hope to accomplish and tell yourself that nothing is going to st
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    and in the way of that goal. It really does not matter whether you like the other side or not. Some parties are rude, obnoxious and insulting. Try to get past these insults so you can focus on resolving the dispute. The other side ma
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    y be baiting you so don’t give them the satisfaction of knowing they have gotten to you. If you focus on the goals of the negotiation, it won’t matter whether you like or respect the other party.

    Rule 2 Look forward, not back. The pa
    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
    st is called the past for a reason.

    If one party gets too involved in what has happened in the past, it can be counter-productive. One party in a divorce case, may be so intent on documenting everything the husband has done wrong, th
    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
    at the wife is not even thinking about the goals of the negotiation beyond blaming the husband. You have to figure out a way to get to the present and deal with current issues of custody or visitation. Ask the other party what they wa
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nt now to resolve the dispute.

    Rule 3 You don’t have to be right to settle.

    What are the three words we want to hear the most, even more than “I Love you”? We love to hear those magic words, “You are right”. For some people, this is
    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
    even harder to say than “I love you”. And if you say, “You are absolutely right”, that is even better. When someone says, “It is the principle that counts” or “It is not the money, it’s the principle!” I know that the negotiation is
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    in trouble. That is because the party is making a judgment call that it is more important to be a martyr than settle the case. When someone is obsessed with the principle of a situation, he/she is still emotionally vested in his/her f
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    eelings. Unless you can get beyond those emotions, the dispute is not likely to be resolved. Feeling that you are right can be a heady emotion, but it has no place in the negotiation. If the other side is only interested in being righ
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t, chances are the situation won’t be resolved.

    Rule 4 Know what you want and what the other side wants

    Knowing what you want may seem obvious, but many parties don’t know what they want. They are so angry that they have not even as
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ked themselves how the issue can be resolved. If they don’t know what they want, how can they go about getting it? They may want to hash and rehash the circumstances that got them into this negotiation. Depending on the complexity of
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    the situation, you should have a detailed plan of what you want. In addition to knowing what you want, you also need to know what you are willing to give up to get what you want. Generally you can get what you want if you are willin
    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
    g to pay the price for it. Don’t ever begin a negotiation without knowing what you want.

    Rule 5 Be prepared and do your research

    Once you have an idea what you want, you must do your research and preparation. That could be as simpl
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    e as listing your arguments on a sheet of paper or as complex as doing the research to cost out a request for wage increases. Either way, you need to be prepared. Otherwise, you might make a concession or agreement that you will later
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    regret. You need to know the rationale behind your requests and a good estimate of the costs, including the future costs.

    Nothing is more embarrassing than making a presentation and having someone question the accuracy of your numbe
    .

    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
    rs and having the whole presentation fall apart because the data is confusing, or even worse incorrect. If you are not completely prepared, consider delaying the start of the negotiation. If you go in with little or no information, an
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    d try to wing it, you will regret it later. You cannot be over-prepared. Even if you don’t use everything you prepared, it does not matter. It is important to have as much information and research as possible just in case you need it.


    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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