Useful Advices - Business

Are you planning your first business meeting and want to ensure you cover all your bases? Don't run around like a crazed wedding planner. Have a strategy and stick to it.

First, set the date and

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

establish the agenda. It's important to prepare the agenda well in advance. You want to ensure everyone has a chance to look it over to get prepared and give you feed back on areas that might need

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

Examples of combination products may in

to be included. In preparing an agenda, envision the purpose of the meeting. How long will it last? How many speakers/presentations will there be? How will the meeting progress? How will you reac

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

your goal for a successful and productive meeting?

Second, set a time for the meeting to begin AND end. It is imperative that you keep the meeting on schedule. You can always go back and revisit

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

unresolved issues as time permits.

Third, find out who needs to be invited to the meeting. Identify people who must be there to accomplish the purpose of the meeting and include people you may n

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

Combination pro

ed to invite because of their status. Make this step easier by setting up a meeting notification procedure whether is by email or regular mail. Attach the agenda to the note so everyone is on the

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

same page from the start. Be specific if there is homework or advance preparation for the attendees. Ask all participants to respond to ensure everyone has received the communication.

Finally, pa

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

attention to the details and logistics. This is where a checklist pays off:

Selecting the room and accommodations

Where is the meeting being held? Is it readily accessible (wheelchairs o

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

r disability access, comfortable room with plenty of sating?

Check the temperature. There is nothing worse to dampen a meeting than a comfortable room.

Identify where the rest rooms are. Locate

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

place where people can store briefcases and luggage should they be traveling to attend.

Make sure there are plenty of seats with room to spread out especially if this is a "working" meeting.

Wi

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

ll you need a translator/s?

Equipment

Will you need AV and presentation equipment at the meeting? Will the presenters need the same? (Check about microphones and podium preferences.) Be

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

Following aspects would a

sure to find out this information well in advance so you can make the appropriate arrangements.

Test all equipment prior to the start of the meeting. If at all possible have a techie ready to han

dd to the challenges in developing combination products:

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

le any snafus that might occur.

Supplies

Have name badges, pencils, pads of paper and other necessary meeting supplies available.

Are documents required? Will there be handouts and mater

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

ials that need to be prepared?

Have them done well in advance in the event of errors.

Assistance

Have a person sitting outside the room for the check in.

Distribute materials or documen

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

s at check in and register attendees.

Secure someone to take notes before the meeting starts.

If you plan to tape the proceeding tell everyone up front that you are recording.

Refreshments
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
b>

Have water, juice, coffee and tea available. If the meeting covers a mealtime, you will also need to provide food. Make the arrangements in advance and have it delivered to the meeting so as n
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
t to interrupt the flow. Keep special dietary requests in mind. It's always best to order a couple of vegetarian items.

Breaks

Depending upon the length of the meeting one or more breaks
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
may be required. Be specific about the time allotted for the break and resume the meeting on time whether all the participants have returned or not.

No matter how well prepared you are there is a
.

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
ways some unanticipated problem. Don't let it get you flustered. Roll with the flow. If you have used these guidelines, you can feel confident that you have done your homework. If something does g
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
o wrong, be on the ready to fix it quickly and quietly. And remember, anything can happen even to the most seasoned meeting planner. Use the event as a building block to future successful meetings

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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Useful Advices - Planning Your First Business Meeting

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