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  • Advice You - What's on Your Meeting Agenda?

    Conducting great meetings depends on several activities that occur before, during, and after each event. To help you establish the conditions for success and attain the very best results, this article lists essential tips on using meeting notices, agendas, and summaries.

    Use Meeting Notices to Alert Your Attendees

    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
    Meeting notices act as an "early warning system" for your participants. You should use them regularly and give recipients plenty of lead time -- for example, at least a week. Avoid surprising people with a last-minute summons that disrupts their entire day. Be sure your meeting notice includes all key information:

    1
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ) Meeting date

    2) Starting and ending times

    3) Purpose and objectives

    4) List of participants

    5) Location with directions or access instructions, and

    6) Proposed agenda

    That way, everyone will know exactly what to expect, what to do, what their time commitment is, and what's in it for them!

    Do All Meetings Nee
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    d an Agenda?

    You may be wondering whether an agenda is absolutely necessary. The answer is, it depends!

    An agenda provides structure; however:

    * the fewer the people involved

    * the fewer the topics you'll have to discuss

    * the longer the time you have available, and

    * the lower your expectations are...

    ...the
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    less you'll need structure to get something done. If, say, you're just going out for a long lunch with a few people to toss around some ideas on a single topic, and you have no real expectations for what you need to accomplish, then you probably don't need an agenda.

    Conversely, if you:

    * involve more people

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

    Combination pro
    discuss more subjects

    * in a compressed time frame

    * with some very specific expectations for the outcome...

    ...then an agenda is an indispensable tool to help people focus on achieving the desired results. Agendas not only prepare attendees for what to expect, they also keep the meeting focused, and make the summ
    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
    arizing aspects much easier.

    A sample meeting notice and agenda appear below:

    =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=


    Meeting Notice & Agenda

    =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=


    Date: Thursday, May 17, 2007

    Time: 9:00 a.m. to 2:00 p.m. PST (a working lunch will be provided). For remote attendees, start a
    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
    11:00 CST, Noon EST, and 5:00 p.m. UTC.

    Purpose & Objectives: The Human Resources Department requests your participation to explore the personnel development needs of the company's centers of excellence in 2007-08. Based on the findings from this session, we will schedule follow-up events to fine-tune our planning
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    process.

    Requested Participants: Representatives from the following centers are asked to attend (or participate remotely via live Web seminar conferencing):

    * Marketing/Sales

    * Customer Service

    * Product Development

    * Quality Assurance

    * Order Fulfillment

    * Publications & Media Design

    * Information Technology
    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


    * Training & Development

    Location: The Cranberry Building, 246 South St., Room B18. Please park in the visitor area behind the building. You will receive parking validations at the meeting. Overnight accommodations and shuttle transportation will be arranged for participants flying in from other locations.

    Remote
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    Access Instructions: For those participating via Web seminar, use the standard company Web seminar link and access meeting #123456. You can listen using voice over IP (VoIP), or call the bridge line at +01-555-555-1212 and use access code 54545#. You will see all electronic slide presentations and can interact with
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    the on-site meeting attendees through a Web seminar facilitator.

    Proposed Agenda:

    1. Overview and agenda review by the VP of Operations (30 min.)

    2. Strategic Planning presentation (30 min.)

    3. Brainstorming breakout sessions, with facilitators (90 min.)

    4. Working lunch and reporting back to the main group (90
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    min.)

    5. Discussion, wrap up, and a review of the next steps (60 min.)

    Handouts will be available on the server 48 hours prior to the meeting. The meeting summary and recorded Web seminar will be available 48 hours afterward.

    RSVP Requested: Please reply no later than April 19, 2007 with the names and contact info
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    rmation for the representatives from your group who will be attending, either on-site or remotely.

    -------------------------------------------------


    So, What about the Meeting Summary?

    The agenda and summary are the two anchor points for the whole meeting process. They represent the beginning (here's what we a
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    m to do) and the end (here's what we did do).

    To create a summary, you simply go down the agenda topics, record the key points, decisions, and action items, and voila! You have a summary. It's really not that hard, but it does take a little time and discipline.

    The summary helps ensure that the valuable time people
    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
    spend in meetings will not be wasted, as the recorded ideas can proceed to drive future actions and decisions.

    A sample meeting summary appears below:

    =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=


    Meeting Summary

    =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=


    This is a summary of the Strategic Planning & Brainstorming meeti
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ng held on May 17, 2007. The Human Resources Dept. called the meeting to explore the personnel development needs of the company's centers of excellence in 2007-08. The following representatives participated...

    Based on the findings from this session, we will schedule at least two follow-up events to fine-tune our pl
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    anning process.

    Summary:

    * The meeting began with the overview and agenda review by the VP of Operations, followed by the Strategic Planning presentation given by the executive planning committee.

    * The brainstorming breakout sessions surfaced a total of 47 major objectives from the centers of excellence, as follo
    .

    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
    ws...

    * During the wrap-up and review session, 15 key action items emerged that Human Resources has agreed to investigate before the next scheduled planning session, as follows...

    * Next Meeting Date: The next meeting will occur on the morning of June 14, 2007 from 9:00-12:00 PST. Further information about that eve
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    nt is forthcoming.

    -------------------------------------------------


    In conclusion, meeting notices, agendas, and summaries encourage participants to contribute in an enthusiastic and meaningful way. They provide a robust structure that can compensate for any other aspects of meetings that are less than perfect


    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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