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1. Put everything in writing – contracts, policies, procedures, actions agreed, meeting notes, etc. etc. You may have to sacrifice a few minutes now, but believe us, it will prove time well spent

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

if it avoids any doubt at a later date.

2. It doesn’t pay to be nice! No, we don’t mean that you shouldn’t be friendly, polite or treat your employees well – just don’t make exceptions or excus

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

Examples of combination products may in

es on the basis of wanting to “be nice” to them. It is a sad but only too often seen scenario, that in letting someone get away with being late one day, this opens the door to them being late eac

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

h week; that by paying full sick pay to your star performer you’ve created a precedent for paying everyone else; and that by turning a blind eye to a policy breach for one ends up negating the wh

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

le policy which you may later want to apply to others. The moral of this story? Don’t be “nice” – be consistent and fair – it’s nicer to all in the long run!

3. Assume your employees know nothin

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

Combination pro

g! Not really as insulting as it sounds, but the safest way to implement concrete policies you can all rely on. If you don’t specifically tell someone something and have the document trail to sho

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

w that they have been told it, you can pretty much assume that in the eyes of the law they can’t be expected to know it! If you not only make policies straight-forward, simple to read and clear t

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

o understand, but get employees to sign to say they’ve read and understood them, then everyone can know where they stand – problem solved!

4. Don’t put off ‘til tomorrow what you should be doing

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

today! You can guarantee that the problem won’t go away, and that things really won’t improve even if left another week. All you can bank on is that you’ll have an even tougher time trying to res

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

olve the issue, and in some instances may even have prevented yourself from safely tackling it at all. If you have a concern – act on it. That doesn’t necessarily mean disciplinary action but per

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

haps simply some constructive feedback and helpful pointers. Just like training a dog or a child, feedback or corrective action needs to take place as close to the event in question as possible o

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

Following aspects would a

therwise the poor creature will have no idea what they’re being chastised (or even praised) for! If you therefore see one of your employees do something you do or don’t like – have a quiet word w

dd to the challenges in developing combination products:

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

th them there and then whilst it’s still fresh in everyone’s memories. If you do need to consider disciplinary action, then it’s even more important that this is tackled in a timely fashion, as l

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

eaving an issue unaddressed for several weeks would suggest to everyone else that it isn’t really an issue at all, making any punitive action you want to consider appear completely unjustified!

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

5. Take a deep breath and count to ten…gather your thoughts, gather your evidence, and most importantly – gather your composure! Whilst you shouldn’t be putting things off, you shouldn’t be rushi

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

ng headlong into spur-of-the-moment decisions either. When you feel like you want to throttle someone (never recommended!) or throw the book at them, try to step back a minute and consider why th

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

Professional from academic institutions, pharmaceutical industries, health care indust

t is. If it is because of what they’ve just done, fair enough; but if it’s because they’re a general pain in the b**t and this last incident was simply the final straw, then you need to tread car

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

efully to ensure your response really does fit the crime. (Think juries not being allowed to know of past convictions and you’re along the right lines). Take time to properly gather your evidence

.

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

, ensure that you have everything you need to present your case, and make arrangements for the best placed people to hold the necessary meetings, making detailed notes as you go. Again, as per Ti

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

Companies that provide selfless information through particip

p1, time wisely spent now in properly preparing for the action you want to take will pay dividends later, and could even mean the difference between a fair and unfair dismissal (and several ?000)

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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Bar codes are a series of vertical bars of different width, in which digits from zero to nine are represented in a dissimilar pattern of bars forming a code that can be read only by a laser scanner. It is representation of machine-readable information on a visual surface. These codes are found on consumer products and are specially used for inventory control.

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Looking at a grant application for the first time may leave you afraid and doubtful of getting funded. However, one way to greatly increase your chances of writing a successful proposal, is to read successful proposals. This article shares the best ways to get a hold of successfully funded grant applications of the past.

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