Main Subject - Business

Organizations continue to struggle with how to gauge the business value of training. Research data shows a significant disconnect between

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

what organizations view as the important and valuable areas to measure and what is actually being measured.

What is usually measured?

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

Examples of combination products may in

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When you get deep into the research (Best Practices in Training Management, Bersin & Associates – interviewed 140 companies of all si

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

zes), the following is a tell-tale list of the top 6 things companies actually measure:

1- Who has completed assignments and on time.

2-

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

How many trainees/students are enrolled in your training program.

3- Satisfaction level

4. #of hours of training

5. Total cost

6. Comp

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

Combination pro

iance

However, when you look at your actual training budget from a business perspective and how much money your actually spending on your

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

training program... the critical disconnect is not having a viable indicator of how all of your training ties back to your business goals

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

and the impact your training has on job performance and your business as a whole.

According to the research, companies SAY that the most

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

important measures of training are exactly that – the impact on employees’ jobs and on the business – but they’re not measuring that.

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

o why such a discrepancy?

There are many reasons – but the major one is that most companies lack adequate tools and a performance man

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

gement process that is needed to exist and coincide with their other measurement tools and reporting.

According to Bersin & Associates’ r

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

Following aspects would a

esearch... more than 2/3 of organizations do not have an integrated process for employee performance management.

While many elearning man

dd to the challenges in developing combination products:

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

gement solutions and systems can measure and report on easily available data such as completions, enrollments, delinquencies and satisfact

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

ion, so many of them do not have the critical performance appraisal function that is needed to obtain any meaningful data on the business

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

mpact of training.

Here’s What You Need.

You need to research the right system for you that incorporates a true performance appra

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

sal and/or certification process that enables you to monitor “hands-on” job performance along side your training program.

The right syste

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

Professional from academic institutions, pharmaceutical industries, health care indust

m will allow you to monitor completions of certain courses and then allow managers an opportunity to set performance goals (tied to the co

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

pany’s business objectives) and evaluate and rate performance based on those goals.

The bottom line is this – most companies need and wan

.

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

t to show the true business impact of training and learning. To do so, they will need to put in place a formal process and integrate an e

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

Companies that provide selfless information through particip

earning management solution and system that has an integrated performance management tool.

There cannot be any compromise.

George Ritacc

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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Main Subject - The Most Important Item To Measure With Your Elearning Management System

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