Your Space - Self Improvement

One of the most effective ways to help your staff succeed is to provide regula

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

r, consistent coaching throughout the year. A Progress Review is a specific k

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

Examples of combination products may in

nd of coaching discussion, tied to the employee’s Annual Objectives and Standa

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

ds. It is an informal discussion in which the manager coaches the direct repo

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

t to meet any unmet goals that are below target, and praises him or her for go

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

Combination pro

als that are being met. Conducting progress reviews are a very important role

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

for being an effective leader or coach. It is suggested that each of your dir

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

ct reports receive a progress review discussion from you at least 2-3 times pe

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

year.

An outline of process for conducting a Progress Review is below:

1. R

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

efer to the annual objectives and standards previously developed. Give a copy

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

to the employee.

2. Ask the employee to review his or her progress to date.

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

Following aspects would a

. Praise the employee for all on-target performance.

4. For below-target perf

dd to the challenges in developing combination products:

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

rmance, ask the employee for suggestions to improve. After all the employee’s

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

suggestions have been made, contribute any additional ideas you may have.

5.

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

Revise and change the standards or objectives where necessary.

6. Set a date

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 the next progress review session.

If you schedule progress reviews with ea

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

Professional from academic institutions, pharmaceutical industries, health care indust

h of your direct report at designated intervals throughout the year, you will

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

find that it helps you remember to conduct these very important coaching discu

.

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

sions. The end result is that your staff will be more productive, and you wil

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

Companies that provide selfless information through particip

be an excellent leader. Don’t put them off! Schedule progress reviews today

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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