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Advice You - Meetings: Planning a Group Session
CHARACTERISTICS OF AN EFFECTIVE FACILITATOR: As chairperson, focus on the meeting’s goals and object
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
ives throughout the meeting. Most everything you say should serve that purpose. A written agenda and
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
visual aids serve as reference points and help to reinforce your purpose. You will make your greate
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
t contribution by asking questions. Questions help to stimulate thinking, navigate the direction of
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the discussion, and sidetrack irrelevant issues. Specific questions might be: “Where would that idea
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lead — What are the consequences?” and “Is this line of discussion consistent with our objectives?”
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
IMPORTANT FACTORS IN PLANNING MEETINGS--VISUAL AIDS: Visual aids, such as flipcharts and transparen
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
cies help you establish a context for the meeting and have a longer lasting effect that just oral pr
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
sentation. When you rely solely on oral communication, it is estimated that 80 percent of a message
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
is often misinterpreted or forgotten entirely soon after its conclusion.
IMPORTANT FACTORS IN PLANN
IMPORTANT FACTORS IN PLANN
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
NG A MEETING--SEATING: Seating arrangements affect the tone and participation in meetings. The chair
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
person should be in a central position to facilitate governance of the meeting most effectively. In
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
small meetings the manager should sit at the head of the table, and in meetings with 12 or more part
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
cipants, in the center on the side. Seating around a rectangular or round table, or semi-circle arra
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ngement, where all participants can have eye contact is generally best. For problem-solving and idea
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
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
generating meetings, this seating arrangement promotes a team-like atmosphere.
IMPORTANT FACTORS IN
IMPORTANT FACTORS IN
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
PLANNING A MEETING--ENVIRONMENT: The physical environment of a meeting weighs heavy on its outcome.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Plan ahead to make this impact positive. For example, try to locate the meeting in a well-ventilate
.
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
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
room, where distractions and interruptions are minimal and lighting and room temperature are comfor
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
table. Use a wide table and place it in a central location so participants won’t be cramped or tense
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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