Main Subject - Business

Have you ever wondered why the training you get on some courses, however interesting and entertaining, doesn't ‘stick'? How many course folders have you got gathering dust on your office shelves? And how much of the content can you

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

recall, or more importantly, actually use, without opening the folder?

Of course, after some training, the learning does ‘stick'. What crucial skill or ability do you have now, that you know you learned on a training cou

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

Examples of combination products may in

se? What distinguished the course which caused the learning to ‘stick' for you?

What's the Key?

There are three critical elements:

The information - the contents, facts, knowledge, tips

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

nd techniques.

The experience or practice you do until the skill is second nature.

The mindset shift that takes away the block that stops you using all that infor

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

ation.If all three are in place, a course can cause remarkable and rapid changes in performance. Many courses, though, concentrate on the information and the experience, butmiss the central role of mindset shift

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

Combination pro

n transferring the learning back to the real world and, more importantly, retaining itover time.

It's a principle well-known in sports psychology. Part of the training of a top sports player consists of physical drills, k

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

owledge of the rules of the game, development of tactics and so on. The other, equally critical, work is done on the mindset of the player. For example, how does he/she feel about their opponent? There may be self-limiting

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

beliefs such as:

‘I have never won at this venue'
‘You can never come from behind and win'
'I'm not quite as fit as I should be'

Without explicitly surfacing, challenging and resolving these

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

eliefs in training, the player, however skilled and fit, will never be truly confident and consistently win matches. It's as if they are trying to play with their foot nailed to the floor!

How Does it Work in Mana

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

ement Training?

For example, there's no real mystery to time management. Most people know the rules, which are some version of: ‘you list the things you have to do, prioritise the list, do the ‘A' priority things first, a

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

d say no to all the rest'. Easy, right? Well no, because the world is full of people who have attended two, three, or even four time management courses! What they seem to be looking for is the magic ‘tip' or ‘hint' that will transf

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

Following aspects would a

orm their time management forever. But there are no magic tips and hints; these are‘information', and will not make the critical difference to how you manage your time.

What's needed, as with the sports player, is an expl

dd to the challenges in developing combination products:

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

ration of yourmindset - of where your ‘foot is nailed to the floor'. This is a very different type of training, targeted at exposing and exploring your beliefs, attitudes, values and ‘rules' in life. The sorts of thoughts that stop

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

people following the simple rules of time management set out above might be:

‘But what if I fail?'
‘It's got to be perfect every time'
‘I can't say ‘no' to that person'
‘There's just too much

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

to do'

‘It's impossible to hit that deadline', and even..

‘But what if I succeed?'!

Thoughts like this need to be challenged and ‘reframed' before it's possible even to start to use the inform

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

tion content of the course.

Why is Mindset-shift the Key?

Very often, in modern large organisations, people have already received much of the basic skills training they need. They are just not using the

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

Professional from academic institutions, pharmaceutical industries, health care indust

nowledge and information they learned because their ‘foot is nailed to the floor'. After a training course centred round surfacing and resolving limiting or negative mindsets, they actually perceive the world differently.

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

hings that seemed impossible before now look very different, and suddenly it is possible to apply all that knowledge and information in completely new, creative ways. The ‘nail' is removed and suddenly those years of training becom

.

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

usable; remarkable changes in behaviour and outlook occur.

To make a truly lasting impact, training must be designed to challenge and shift the mindset of the course participants. Bear this in mind, and you will always be able to

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

Companies that provide selfless information through particip

choose courses which are truly worth the time and money you spend on attending them.

==> For more information view the original newsletter article here <=

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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