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Strategic planning by its nature involves goals. Yet, do your people know how consistently plan, set and achieve their

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

personal goals? If they can’t consistently achieve what matters most to them personally, how will they achieve what matters to

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

Examples of combination products may in

you as the organization?

Yes, you may have adopted a proven goal setting process, but that is only one piece of the puz

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

le to effective strategic planning. Until your people are trained and truly developed to use the process and any supporting goa

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

setting tools, execution of your strategic plan will still allude you.

The usual approach in training and development

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

Combination pro

s to hold a half day, full day or even 2 day training event. Research continues to reveal that this solution does not deliver

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

positive return on investment for the dollars expended nor does it deliver any sustainability. Also, the training and develop

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

ment are usually for a particular segment within the organization and does not extend from the top down.

So what would an effe

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

tive training session for goal setting and goal achievement look like and include? That is a good question. These 3 points may

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

elp you answer that question.

First, recognize that the issue to sustainability is to look at the current attitudes that are b

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

ing demonstrated through the behaviors. This actually begins by identifying the beliefs that are behind the attitudes. Until

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

Following aspects would a

his step is completed, effective learning that being the acquisition of knowledge and effective performance that being the appl

dd to the challenges in developing combination products:

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

cation of knowledge will not take place.

Second, include the WAY SMART goal criteria. As performance improvement consultant a

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

d executive business coach, I realized that the SMART criteria alone was not helping people secure consistent goal achievement.

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

By adding 3 additional criteria, my clients have been able to have greater success in reaching their goals.

W – Is

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

or written. All goals must be committed to writing for enhanced clarity.

A – Is for aligned. All goals must be alig

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed to the strategic plan.

Y – Is for yours. All goals must be yours.

Third and last extend the training

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

over time. By allowing practice time between learning events, begins to build the foundation necessary for improved performance

.

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

When your people can consistently plan, set and achieve both personal and professional goals, your elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

://www.processspecialist.com/organizations.htm">organization will reap incredible results including increased profitability

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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