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WHEN ONLY A LECTURE WILL DO: Under certain circumstances, of course, the lecture is the only workable format. For instan

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

ce, when it is necessary to reach a large audience in a short time frame, or when the attendees have no knowledge of the

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

Examples of combination products may in

subject whatsoever, there is really no choice. But whenever possible, alternative methods should be investigated. If you

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

choose to rely solely on lectures, be aware that you do so for your own convenience and comfort, rather than for the eff

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

ctiveness of the training. Abandoning the lecture format for that of group discussion requires that the trainer step bac

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

Combination pro

from leadership and take up the role of facilitator — a position much closer to that of the participant. If this method

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

of training is one that you would like to explore, it is first necessary to examine potential problems which make group

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

iscussions difficult for some trainers.

HANDLING A LECTURE: In handling a lecture, you must get attention, maintain int

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

rest and eye contact, and watch for audience reaction. In a group discussion, on the other hand, the object is to avoid

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

llowing your ego to impede the flow of ideas. It is hard to relinquish control of the discussion when it moves away from

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

the points you most want to make. This is especially difficult for individuals who feel so strongly about a subject that

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

Following aspects would a

they tend to force opinions on others. Obvious attempts to steer the discussion in one direction will be seen as manipu

dd to the challenges in developing combination products:

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

ative, and this may lead the participants to “turn off” to the entire process.

PURPOSES OF GROUP DISCUSSIONS: Starting

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

discussion indicates that you want to broaden the interaction between the group and yourself and share the responsibili

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

y for the learning experience. Although you lose some of the personal control over the learning situation that you exerc

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

se as the instructor, you gain overall training effectiveness by stimulating interest in the exploration of new ideas an

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

Professional from academic institutions, pharmaceutical industries, health care indust

solutions. By engaging their emotions and interest, you encourage the trainees to personalize the ideas and concepts pr

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

duced by the group. You create a situation where the experience has emotional resonance and individual memories, making

.

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 more easily and readily retained. The trainees will take the learning experience from the group into their outside emp

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

Companies that provide selfless information through particip

oyment situation. In short, you will be able to create a learning environment which is most conducive to behavior change

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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We're only a few fields away from coming to our conclusion of this medical billing series on the GU0 record, one of the most complex records of electronic billing. In this installment we pick up with field number 66.

Now, six weeks into the new job you know in your gut and sleepless nights that maybe, just maybe, you’ve made the biggest mistake of your career.

Managing your company's most valuable resource (people) can provide challenging and rewarding opportunities for your own professional development and growth. The manager must find creative solutions to promote the best in each of their employees. Mentoring employees who suffer from agency attention deficit requires that the mentor use techniques which provide measured success for both the agency and the individual.

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