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You don't have to be on a stage to be a public speaker. Your platform may be a meeting room. How you present yourself when chairi

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

ng a meeting determines whether or not you are perceived as a leader. Here are some tips to keep in mind when it's your turn to t

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

Examples of combination products may in

ke charge.

Know why you are holding the meeting. What outcomes are you trying to achieve? This will keep you focused and purpose

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

ul.

Clarify your role as chair. How do the participants perceive you? Did you call the meeting? Do participants report to you? I

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

you're the boss, people may be scared to speak their minds .If you're not the boss, what do people expect from you as the chair?

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

Combination pro

Set a positive tone early in the meeting. Greet people before you sit down. Break the ice with some light humor to relax the gro

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

up. People are often tentative and guarded during the first few minutes. Provide coffee if appropriate. People bond around food 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

d drink.

Provide a written agenda on a handout or flip chart. The agenda keeps the meeting on track. Let the group know the time

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

frame and guidelines for working together. "We have only forty minutes today. I will update you on the customer service situation

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

and then I'd like us to brainstorm some solutions to the challenges we face."

Start on time. Don't wait for stragglers. If you

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

egin and end on time, you'll condition people to be prompt.

Create interest with an enticing title. Instead of a management topi

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

c about "Business Etiquette" title it "What's Rudeness Costing You?"

Appoint a person to take minutes so that you can later revi

dd to the challenges in developing combination products:

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

w discussions that took place and the decisions that were made.

Manage the group dynamics. Don't let one person dominate. Ask fo

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

other opinions. If some people are silent, draw them out by asking for their thoughts.

Handle conflicts impartially. Encourage

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ooperation by clarifying what people have said and then asking the participants to propose solutions. Heated arguments may requ

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

re a timeout in which group members take a short break and return when they've cooled off.

Assign a timekeeper if time is a majo

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

r constraint.

Give a short summary or recap before going on to the next area. Be sure people understand what the group has agree

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

to.

End with an action step...Meetings fail because people aren't held accountable. Summarize the action steps the group member

.

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

are to take and attach a time frame to each action. The only way to get commitment is to assign a deadline.

By following these

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

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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