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    One of the main complaints heard by human resource professionals and team managers has to do with an 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
    voidable and a controllable problem… wasteful meetings. Most business organizations have too many meet
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ings that waste time and drain money. Profits and morale can be severely impacted by poor meeting mana
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ement.

    As a guide to meeting management, great managers can start by asking: Is this meeting really n
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ecessary? And, what are the meeting’s desired outcomes?

    Other good questions include:

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

    Combination pro
    s to attend?

    Who needs to be involved in planning the meeting’s agenda?

    What is the level of formali
    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
    ty necessary for this meeting to be effective?

    Who and what should be on the agenda?

    When and where
    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
    hould this meeting take place? What, if any, equipment will be required for the meeting’s presentation
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    s?

    Besides a copy of the agenda (to all attendees), what information should be prepared and circulate
    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
    prior to the meeting? Will any briefing be required prior to the meeting for participants?

    How will
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    the meeting be recorded?

    Before the meeting, what follow up meetings or activities can be developed f
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    rom this meeting?

    Ten Essential Tips to Meeting Management:

  • 1. Purpose of meeting and act
  • dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    on items: Send to every participant in advance (for comment and preparation.)
  • 2. Agenda – Priorit
  • cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ize – time required for each item
  • 3. Who should attend and for how long are they needed
  • 4. S
  • tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t up of room to accomplish meeting’s goals
  • 5. Running the meeting: chairman, ground rules, time k
  • 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
    eeper, note taking
  • 6. Mid-point review of meeting (everyone participates)
  • 7. Closing: restat
  • ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    outcomes/decisions and establish action plans
  • 8. Schedule follow ups
  • 9. Evaluate Meeting –
  • y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    did it meet objectives and how could have been more effective
  • 10. Circulate notes and the follow
  • .

    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
    p action plans

    Avoid wasting people’s time by having only required participants at the meeting and st
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    aying focused on the agenda. The key may be in good communication before, during and after the meeting


    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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