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STEPS IN USING THE CRITICAL INCIDENT TECHNIQUE:

1) The incident. Rea

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, review, or assume roles. Begin the investigation of the incident s

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

Examples of combination products may in

ituation.

2) Fact-Finding. Collecting the details of the incident oc

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

curs in the small group discussions where the participants determine

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

what they know about the situation and what else they need to know be

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

Combination pro

fore making a decision. They decide what questions to ask the instruc

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

tor.

3) The issue. When the groups have all the facts needed to deci

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

e the case, they should identify what they consider to be its central

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

issues.

4) The Decision. Each trainee or group writes a decision on

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

the incident and cites the central issues identified. The group memb

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

ers state how they would like to see the situation handled and why. I

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

Following aspects would a

ndividuals or groups with varying responses to the same situation may

dd to the challenges in developing combination products:

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

be allowed to debate their rationale for the decision.

5) The Evalu

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

ation (the most important stage). In large groups the instructor guid

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

s the groups to focus on broader issues of the incident to analyze po

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

tential solutions to determine if the alternative courses of action w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ill cause more trouble and to determine if the root causes are still

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

present in the situation. Evaluate the exercise by centering on WHAT

.

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

WAS LEARNED BY THE EXERCISE AS A DEMONSTRATION OF THE CRITICAL INCIDE

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

Companies that provide selfless information through particip

NT TECHNIQUE, not on who has the best decision to the incident itself

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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