Advice You - Business

Never rehearse at the last minute. This creates undue tension

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

and nervousness and does not allow sufficient time for correct

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

Examples of combination products may in

ing mistakes and polishing delivery. Ideally, the first full a

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

uditory rehearsal should take place at least a week before the

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

presentation date and be conducted in undisturbed surrounding

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

Combination pro

s. If possible, use the room in which the presentation will be

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

given. If not, use one as similar to it as possible.

Do not

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

forget this important matter. If the presentation runs over in

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

rehearsal, it will do so under actual conditions. Rehearsals

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

tend to compress information, so the presentation itself shoul

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

always be planned to run just a little under its time limitat

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

Following aspects would a

ions. This margin of safety will ensure that the actual presen

dd to the challenges in developing combination products:

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

tation will not run over. It is also good psychology to end a

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

little early.

Time each supportive aid to be sure that it is

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

exposed only long enough for full comprehension. Also, time ot

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

her activities to verify that they fit within the time allotte

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

Professional from academic institutions, pharmaceutical industries, health care indust

d for the presentation. Furthermore, do not forget to proof-re

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

ad all handout material in its final form and make sure there

.

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

will be enough for the anticipated attendance.

These tips sho

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

Companies that provide selfless information through particip

uld help you to arrive at a finished and polished presentation

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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Advice You - Quick and Easy Rehearsal Tips

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