Advice You - Business

Conventional management training typically consists of single, time-limited workshops or seminars. The length of the event varies by position level, function or business dis

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

cipline, and size and structure of the employer organization.

For new managers, this model has inherent shortcomings:

• The large amounts of new information that must be c

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

Examples of combination products may in

ammed into a short time is overwhelming and often leads to feelings of panic.

• Participants can't put the new learning into practice until the course is over, leaving no o

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

portunity to ask questions of instructors or colleagues after they try the techniques in the course of their jobs.

• In-house management training often incorporates company

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

-specific material. Although well-intentioned, this practice confuses the issues, and too often fundamental management skills don't receive adequate attention.

• Courses ta

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

Combination pro

e new managers away from their tasks at exactly the time when they need to give all their energies to the job. Not only does this dilute their concentration, but when the co

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

rse is finished, the urgency of the day-to-day job activities leaves little time or opportunity to implement the new learning.

• There is an emphasis on "leadership skills"

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

, including concepts like authenticity, cultural fit, conceptual thinking. These are, of course, important, but inexperienced managers are struggling with the practical chal

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

enges of running meetings, making presentations, managing difficult employees, hiring and firing team members and a plethora of other everyday management activities. New man

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

gers can strongly relate to the old expression, "When you're up to your ears in alligators, it's hard to concentrate on draining the swamp!"

New managers need a new approac

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

.

The corporate world needs a new training model specifically tailored to the needs of new and recently appointed managers. This model should:

• Focus on universal managem

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

Following aspects would a

ent principles. At the more senior management levels, issues are more situation-specific, but the problems facing new managers are universal in nature. These problems and th

dd to the challenges in developing combination products:

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

ir solutions should be the focus of the training.

• Provide for ongoing on-the-job learning. One-time programs, whether they last for half a day or two weeks, leave partici

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

ants wondering how to put the techniques into practice while "putting out the fires" of everyday workplace life. An effective training program will allow managers opportunit

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

ies to implement the newly learned practices and techniques and discuss the results.

• Make use of technology where appropriate, but also of the human element so essential

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

o effective learning.

• Cover practical skills for management tasks such as running meetings, interviewing job applicants, planning and goal setting, etc., as well as conce

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

Professional from academic institutions, pharmaceutical industries, health care indust

tual subjects such as emotional intelligence and leadership.

• Explore the concept of career management. This should include the importance of taking responsibility for the

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

ir careers, and the best practices on how to do so.

• Follow the principles of adult learning by first conveying information about a subject, then providing examples of rea

.

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

-world application, and finally giving guidance on how to implement the ideas in the workplace.

When it comes to management training, one size does not fit all. If they are

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

Companies that provide selfless information through particip

to fulfill their promise, those who are new or recently appointed to management need separate training that provides specific education in the universal skills of management

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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