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Why do some new managers succeed while others fail? It all depends on the first th

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

ree months – the critical time when the new hire is learning the ropes. The new ma

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

Examples of combination products may in

nager’s boss plays a vital role in the orientation process. Here are four stra

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

tegies to quickly get the new hire up to speed and working productively

Cl

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

arify goals and priorities.
What are the performance expectations and d

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

Combination pro

eliverables for you and your team? How is performance going to be measured/succes

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

s evaluated? What are the key business issues that you need to focus on?

Defi

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

ne responsibility and accountability.
How much operational freedom/auto

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

nomy is there? What types of decisions require approval, consulting, or advising,

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

and/or are subject to veto? Who else is significantly involved in any decision-

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

making? On what basis?

Agree on communication.
What is the frequenc

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

Following aspects would a

y and type of preferred communications? Is it regular meetings? Written, e-mail r

dd to the challenges in developing combination products:

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

eports? Event-based communications?

Identify current 'hot issues'.

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

What do you need to watch out for? For example: Relationships among team member

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

s; client histories and experiences with the company; operating and performance pr

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

oblems.

The good news is that orientation offers an opportunity to build a lastin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g impression of the new company. The bad news is that that is going to happen whet

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

her you plan it or not.

Make sure you get your new managers off to a great start.

.

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

Employee orientation, whether it takes one hour or one day, is a critical opport

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

Companies that provide selfless information through particip

unity – don’t waste it. What’s your orientation program like? Do you even have one

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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