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To most organisations, the benefits of investing in ongoing staff training are clear. They include:

Process improvements: reduced duplication of effort, less time spent correcting mistakes, faster access to information, etc.
Cost savings: lower staff turnover, lower recruitment costs; reduction in ba

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

d debts; reduced customer support calls; reduced help desk calls; reduced need for supervision; reduced downtime; increased staff productivity; fewer machine breakdowns; lower maintenance costs, etc.

Improved profitability: increased sales; more referrals due to better customer service; new product ideas; imp

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

Examples of combination products may in

oved customer satisfaction and retention, etc.

Performance improvement: in quality, quantity, speed, safety, problem solving, etc.

Behavioural improvements: in attitude, ethics, motivation, leadership, communication, reduced staff conflict, etc.

Increased staff satisfaction: Well trained staf

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

f tend to be happier, stay longer, and are more loyal.

Furthermore, research undertaken to uncover the financial impact to an organisation of investing in staff training shows a clear and quantifiable link between an above average investment in staff training and superior bottom line perfo

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

mance:

Based on the training investments of 575 companies during a 3-year period, researchers found that firms investing the most in training and development (measured by total investment per employee and percentage of total gross payroll) yielded a 36.9% total shareholder return compared with the 25.5% weig

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

Combination pro

ted return for the S&P 500 index for the same period. [1]

Firms that invest $1,500 per employee in training (per year) compared with those that spend $125 experience an average of 24% higher gross profit margins and 218% higher revenue per employee. [2]

Just a 2% increase in productivity has been sh

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

own to net a 100% return on investment in training. [3]

A Louis Harris and Associates poll reports that among employees with "poor" training opportunities, 41% planned to leave within a year, whereas of those who considered their company's training opportunities to be "excellent", only 12% planned to leave 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

thin the same period.

So, if we accept the findings above that support the case for investing in a formal staff training program, how does one go about identifying staff training requirements and putting a suitable program in place?

Enter The Staff Skills Audit:

If a c

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

ompany's strategic plan involves doubling the workforce size within 3 years and opening two completely new divisions during that period, then you would hope that the company's HR Management team have a good handle on what skills the company currently has, and what new skills it needs to obtain in order for t

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

e company to meet its business objectives. As such, a staff skills audit (uncovering current situation) and training needs analysis (guiding future direction) is a vital first step in obtaining company-wide quantitative data on what skills an organisation's workforce currently has, and (based on the company's busines

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

objectives) where the skills gaps lie.

Whilst conducting face-to-face meetings with a select few staff members to discuss training requirements, or ensuring training needs are raised with staff at their annual performance reviews can both be a worthwhile exercise, neither approach will give you an accurate company-

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

Following aspects would a

wide picture of the organisation's skills status and future training requirements at one point in time. As such, an annual or bi-annual online staff training needs survey is becoming an increasingly popular approach to address this requirement.

When assessed against the alternatives of paper-based or face-to-face tr

dd to the challenges in developing combination products:

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

ining needs analysis surveys, we find the online approach has a number of clear advantages. These include:

1. Speed and ease of reporting: online survey results are generated instantly, and anyone given authorisation can access the results from any web browser in the World, at any time, with the data securely held o

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

n encrypted servers. If the same survey is used results can also be compared from month to month, or year to year to help spot trends and assist with budgeting and planning. The online approach also saves significant time with distributing and administering the survey as a survey link is simply e-mailed to employees.

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

2. Data entry time/expense/errors: the online survey quickly stores the exact data and scoring entered by each employee. Management's data entry requirement is removed.

3. High cost: compared with the paper or face-to-face alternatives, the online TNA process has been shown to cost up to 80% less, and reduce decisi

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

n making time by up to 90%.

4. Consistency: when a decentralised, verbal training needs analysis system is replaced by a centralised online process, the training survey issued is the same for all employees and comparison of like-for-like results made easy.

5. Interviewer bias or interpretation errors: the 'intervie

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

Professional from academic institutions, pharmaceutical industries, health care indust

w' is in the form of an online survey and what the employee types is exactly what HR report on.

Once the company-wide survey has been conducted, the next steps in the training strategy development process include:

Analyse the survey results.
Create a staff training profile.
Develop a t

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

aining development plan.

Communicate the training development plan to all employees.

Implement the training.

Evaluate the training effectiveness. [4]

It is recommended that this process be conducted on a 12 monthly cycle at a minimum. In short, a well constructed skills aud

.

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

it and training needs analysis process will provide a fast and accurate snapshot of workforce training requirements, assist with training vendor selection and budgeting, and ultimately help improve employee retention levels and overall staff satisfaction.

Research sources:

1. American Society for Training and Devel

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

Companies that provide selfless information through particip

pment (ASTD).

2. Laurie J. Bassi et al., "Profiting From Learning: Do Firms' Investments in Education and Training Pay Off?" American Society for Training and Development, 2000.

3. "The 2001 Global Training and Certification Study," CompTIA and Prometric.

4. EOWA.gov.au - 'Training Needs Analysis and Skills Audit'

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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