Advice You - Business

As we all know there is office gossip and rumours that abound in the workplace. Some of them start as a joke and some as a result of overheard misin

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

terpretation of a conversation. What we need to remember is that rumours hold no power on their own, it is the person that is passing it on that len

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

Examples of combination products may in

ds it credence. Now we do not want to allow us to stoop to their levels of unprofessionalism, but as it is your reputation that is being tarnished y

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

ou need to address this as soon as possible. We do need to make sure that the rumour has no credibility, so before we go and address this with the p

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

rson we need to be objective in our view of what we have heard. Are there any circumstances under which this could be considered true? Most likely n

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

Combination pro

ot, but it is definitely worth the effort to make sure you seeing yourself in others eyes.

So now lets try and establish how the rumour started, wa

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

s it because someone just does not like you, or was it because of a misunderstanding. Either way if we can establish the source of the rumour then w

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

e should go to them and request to speak with them in person. If you are unsure of your ability to remain calm in the conversation you may request t

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

at someone else be present to mediate, this would preferably be a supervisor or someone to whom you are inclined to listen if you are getting carrie

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

d away. Now you have the opportunity to explain to them what you know and why you are addressing it with them, remember this – they may not be the s

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

ource of the rumour. At this stage you are on a fact finding mission, so you may want to start the conversation with something reasonably neutral an

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

Following aspects would a

d unaccusing such as: " As you may know there is a rumour regarding me going around. I was told that you may have some information in this regard an

dd to the challenges in developing combination products:

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

was hoping you could help me get to the bottom of this issue." This gives them the opportunity to be honest and tell you what they do know about it

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

. Obviously they may lie to you at this stage, however you have established your credibility. If they deny any knowledge you can end the conversatio

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

n by asking them to let you know if they hear anything else. At no time should you tell them where you heard that they know some information. This p

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

uts your source in a bad light and may prevent you from getting to the bottom of the issue as they could immediately start to attack your source.

Y

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

Professional from academic institutions, pharmaceutical industries, health care indust

u may give them details of the rumour if they request it, as this may be totally different from what they said, as we all know messages and rumours

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

get elaborated on every time that they are passed on to the next person, so by the time you have become aware of it, it could be totally different f

.

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

rom how it started out.

Lastly you should also advise them that you don't appreciate that people talk about you in a manner different from how they

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

Companies that provide selfless information through particip

would speak to you. Basically you are telling them that if they have an issue with you to at least say it to your face so that you can deal with it

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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