Useful Advices - Business

Meetings can consume major portions of the workday. If something significant doesn't occur during (or as a result of) the meeting, the time will have been wasted.

If you are in charge of a meeting:

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
rong>Before scheduling a meeting, ask yourself, "Why do I need to have everybody in the same room?" If you can't think of a good reason, don't call the meeting.
Give attendees plenty of

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

Examples of combination products may in

dvance notice. This goes for meeting cancellations as well.

Prepare an agenda, with items listed top-to-bottom in order of importance, and give it to invited attendees ahead of

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

ime.

Schedule adequate time to cover the items on the agenda and any important side issues that may crop up during the meeting.

Ensure that the meeting room has everythin

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'll need, such as a white board or projector.

Show up early for the meeting to see that everything is in order.

Introduce everyone at the beginning

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

Combination pro

f the meeting.

Address the items on the agenda one at a time. If you run out of time, ask the attendees if they would like to continue or schedule a second meeting.

Never

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

allow meetings to unexpectedly run beyond the end of the workday.

Don't allow any one person to dominate the meeting or bog down the group. It's your meeting.

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

QUICK TIP: If an attendee is chronically negative in your meetings, give them an action item before the meeting. i.e., "Mark - I know you care a lot about this issue. Could yo

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

put together a two minute summary of your opinions on it and present it at the next meeting?" Many times being in the spotlight will change their attitude.

If you're an invited attendee:

Review the ag

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

nda before arriving at the meeting.

Show up on time or early.

Bring paper and a pen.

Bring business cards to hand out to anyone who needs one.

Listen actively and take notes.

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

li>Maintain the formality or informality established by the chairperson.

Don't be afraid to ask for more detail or an explanation if you don't understand something. Someone else may be wondering the same

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

Following aspects would a

thing.

Provide input whenever possible.

Don't engage in side conversations.

Apologize if you are late, but don't make excuses. No one really cares what held you up and it further delays t

dd to the challenges in developing combination products:

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

e meeting.

Never bring friends, spouses, children, or others to business meetings.

If the meeting involves a conference call:

Call in a few minutes early to allow tim

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

for resolution of any technical difficulties.

Avoid using a cell phone. Reception is usually not as good as on a land line, and if you lose your signal and get disconnected it is very d

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

isruptive to the meeting.

If your phone has a mute button, use it whenever possible to cut down on background noise and improve the quality of the call.

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

g>QUICK TIP: Never trust the mute button and never assume you know who's listening.

Pay attention! It's very tempting to multi-task while on a conference call, but the clacking

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

Professional from academic institutions, pharmaceutical industries, health care indust

of a keyboard or having to repeat information because someone wasn't paying attention is very annoying.

Before speaking, state your name. For example, "Jay, this is Kathy. My team will h

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

ve no problem making that date."

Tips for everyone:

Don't rehash moot points.
Cooperate rather than agitate.
Deflect rather than respond to personal attacks.
Keep your

.

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

emotions in check.

Greet and treat everyone with respect.

Come prepared with all necessary documents and agreements.

Keep an open mind.

Don't insist that the opinions and position

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

Companies that provide selfless information through particip

of others are wrong. Suggest that they look at it from another perspective.

Don't threaten.

Don't do non-relevant tasks during the meeting, like typing on your laptop or reading papers.

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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