Main Subject - Business

Starting the Meeting

Test the dial-in number and access password 10 minutes prior to s

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

tart of meeting to ensure the phone call conference service is available and scheduled properly.

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

Examples of combination products may in

State your name first, before the business meeting begins.

Appoint someone other tha

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

n moderator to take meeting minutes. Whoever is taking minutes should have their phone muted beca

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

se the clicking of typing will be too distracting for others.

Have a prepared reference li

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

Combination pro

t of who is attending the conference call meeting.

Conduct a roll call so you know who is

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

on your conference call.

Request that each participant use the "Mute" button on their loca

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

phone to reduce background noise problems. Instruct participants to only "Un-mute" when they nee

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

to speak. During the Meeting

Do not put your phone on HOLD. This usually puts

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

music into your conference and prevents others from continuing the meeting.

If no one in

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

our room needs to speak, use the "Mute" button on the phone to prevent background noise from disr

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

Following aspects would a

pting the meeting. When someone needs to speak, simply release the "Mute". Concluding the

dd to the challenges in developing combination products:

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

Meeting

Make a last request for additional questions or concerns prior to ending the

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

all.

Establish the day and time for your next phone call conference.

After c

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

osing the meeting and bidding farewell to your audience, be the last person to disconnect from th

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

e call.

Forward meeting minutes to the audience within 24 hours following the phone call c

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

Professional from academic institutions, pharmaceutical industries, health care indust

nference.

Conclusion

Using the tips listed above, your next phone call conferen

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

e can be a winner for all attending. Plan in advance, and take the time to ensure the co

.

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

nference number works just before the meeting. Be flexible and even humorous about small problems

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

Companies that provide selfless information through particip

that make occur during the call. Your professionalism in handling such situations will be evident

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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