Advice You - Business

Training is not new to small businesses or to the Fortune 1000 corporations. Employees must be trained to learn specific skill sets

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

within their job functions as well as policies and procedures. This is especially true in today’s technology driven 24/7 business w

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

Examples of combination products may in

rld.

During the last 100 years, training has been viewed by some as the necessary evil. The prevailing belief was "We got

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

a to train them." And when sales plummeted or companies merged, the leadership’s or management’s belief was to cu

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

t the training budgets as well as the human resource department. Now does this really make sense?

If your people are the ke

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

Combination pro

to overcoming current challenges, then why cut their resources when you are experiencing significant issues. This is the time more

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

than ever to invest (key word here is invest) in YOUR people.

Slashing the training budget is in many cases a reactio

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

n to a symptom instead of the real much larger problem or problems. That problem or those problems may include the following:

I

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

ability to define the desired results
HINT: If you can’t define the desired results that you want from the trainin

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

, then why do the training? This is now a management problem, not a training problem.

No Strategic Plan
HINT: I

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

there is no strategic plan (who does what by when), the you and your people are on some one else’s plan and the problem is poor pla

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

Following aspects would a

nning, not training.

Outdated Strategic Plan
HINT: If you haven’t revisited your plan within the last 30 days,

dd to the challenges in developing combination products:

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

then the problem is not training, but again poor planning.

Poor Communication
HINT: If 100% of your people can

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

ot tell you what the top 3 goals of the organization are for the current year, you have a communication problem not a training probl

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

em.

Inconsistent Leadership
HINT: If your act

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

ons are not consistently focused on the end results and your behaviors are not demonstrating the shared common values, then you

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

Professional from academic institutions, pharmaceutical industries, health care indust

ave a leadership problem, not a training problem.

With the New Year fast approaching and the quarter quickly ending, now is the tim

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

e for you as that forward thinking business leader to use your leadership skills to assess what the real problems that you ar

.

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

facing and not just the symptoms. Begin to belief that training is an investment in your people and therefore in your organization

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

Companies that provide selfless information through particip

For without those most advanced systems (your people) in your business, you wouldn’t be able to conduct business, would you?

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 - Management: Training Is An Investment for Forward Thinking Business Leaders

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