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  • Advice You - Renegotiate Deadlines - How To Do It To Lighten Your Workloads!

    A couple of my trainers have just come back from facilitating a Team Leader soft skills management course and gave me a great example to use for this week's Quick Tip!

    Here's the question that was asked from the course
    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
    :

    "I feel really uncomfortable when my boss sets me a deadline and then half way through the piece of work I know that I can never meet the deadline set. I feel awkward and stupid going back to ask for more time and I j
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    st end up coming out with a list of excuses

    - how can I approach this better?"

    This is a great question!

    A lot of us think that our boss will frown upon us by going back and asking for more time so instead we get all st
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    essed out about the work and put in even more hours than the 10 hour day we were working in the first place!

    Never make excuses with your boss. No-one likes to hear excuses, especially your boss!

    Instead, renegotiating
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    a deadline is all about making a subtle trade off.

    The position you need to get to is when you are "purchasing" more time from your boss in return for giving him/her something.

    I know that sounds odd but hear me out.

    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ou need to persuade your boss to "sell" you more time in exchange for value received.

    You have really got to make it clear to your boss what the additional time will buy. Here's an example:

    "We really want to do a thoro
    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
    gh and well prepared proposal here, I'm going to need an extra 2 days Bill. I don't think it will do us any good to try and rush it and end up neglecting a, b and c"

    Do you see how more effective that is than just sayin
    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
    g "We need more time"?

    Another important thing to note is that you should view the shift in the deadline as a simple alteration rather than a crisis - be careful with HOW you say it.

    Also, offer your boss alternatives
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nd solutions. Make sure you always offer them choices.

    Here's a great example:

    "I can get the first proposal done by next Tuesday, with full costings and case studies by Thursday and the whole project completed by the
    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
    ollowing Monday"

    Here is another...

    "If I put back doing xyz I can get a and b to you for Friday"

    So what happens if your boss pushes back?

    Your boss might come back with...

    "I need this work completing by the deadline
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi


    When responding to these types of statements always try to spin the situation around and mention things like:

    1. The boss wants the best possible job completed doesn't he/she?

    2. You take great pride in doing an exce
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    llent job

    3. You do not want to cut corners now because it will save time down the line

    4. You will not be comfortable with the results if you rush it

    5. ...and if you're not comfortable then your boss will not be comf
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    rtable

    Here's an example:

    BOSS

    "I really do need that proposal by Friday Sean"

    SEAN

    "I would love to have it completed by Friday as well "BOSS", you know I take great pride in finishing a job to the standards that w
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    set and on time. On this occasion to get the job completed by Friday will mean that I will have to cut corners though and I will feel really uncomfortable with that and I am positive that you will feel the same if we go
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    down that route. If you can give me until Tuesday morning, I will have the proposal complete plus I will be able to do a detailed costings breakdown in addition to what we had planned"

    Let's bisect my reply above along
    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
    with the hidden messages it gives to my boss:

    "I would love to have it completed too"

    - means that I want it completed as much as you by Friday.

    "I take great pride..."

    - I set really high standards because I do not wa
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    t to let you down

    "I would feel uncomfortable..."

    - My standards would not be met if I rush it for Friday.

    "Cut corners.... you will feel the same too"

    - Surely you do not want a sub standard job because you have very
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    high standards the same as me.

    "If you give me until Tuesday morning..."

    - I am offering a solution and date when I know that IT WILL be up to our very high standards

    "Provide detailed costings in addition..."

    - I am o
    .

    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
    fering an additional piece of work that will add value to the proposal

    Then go on to ask your boss whether they are comfortable with it - but let them make the decision. If they are happy with a sub standard job then t
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ey have made that decision and have to live by that.

    Always think about the quality of work if the job is rushed, the pay off for the delay and what you will both look like if the job is not up to the required standard


    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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