Advice You - Business

If you manage others, delegating is a critical skill. There are many excuses why people don't delegate, but there is one important rule of thum

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

b. If you want to develop others and free yourself up for higher level tasks, you should consider delegating anything that someone else can do

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

Examples of combination products may in

0% as well as you.

The fact is that it is highly unlikely that your staff will be able to complete a particular task or project as well as 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.

at first. You probably have more expertise and experience; isn't that why you're the boss? If you want to grow your staff and your organization

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

however, you will need to develop additional skills and competencies in your people. Here are the seven steps to mastering delegation:

1. Dev

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

Combination pro

lop a climate for delegation - By placing value in the feedback and work of others, your staff will feel appreciated and work harder. They will

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

want to contribute in new and different ways to the success of the organization.

2. Determine your objectives - Before you get started, you ne

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

d to ask yourself, "What do I want to get accomplished?" With that in mind, "What tasks can be done by others?" When you are mapping out the ac

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

ion steps to a goal, always consider who can handle the different tasks involved.

3. Know your workers - Who would be the best person to compl

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

te a particular task? If you understand and know your employees' strengths/weaknesses and likes/dislikes, you can match up assignments more app

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

opriately.

4. Develop a plan - You should have an overall work plan or goal planning summary that spells out responsibilities and deadlines. T

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

Following aspects would a

his plan can be done in conjunction with the employees being held responsible for the various tasks.

5. Communicate your expectations - Your e

dd to the challenges in developing combination products:

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

ployees must have clear directions and a full understanding of the deadlines and expectations. Make sure that they understand what you're commu

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

icating. The use of clarifying and confirming questions can ensure proper understanding. If you are unsure if the employee "gets it," you can a

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

so ask them to repeat their understanding of the situation back to you.

6. Monitor progress - Make sure that you monitor and assess the employ

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

e's performance on a particular assignment and give appropriate feedback. This is particularly critical when a new assignment or responsibility

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

Professional from academic institutions, pharmaceutical industries, health care indust

is being handled by an employee.

7. Evaluate results and assign new work - At the completion of the project, review the results to make sure y

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

ur objectives were met. If you outlined your expectations and the results desired on the front-end, this should be easy to measure. If the job

.

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

as completed in a satisfactory manner, congratulate and praise your employee. You can also look for additional opportunities to assign new work

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

Companies that provide selfless information through particip

If the desired results were not achieved, use this as a teaching and learning opportunity. Continue to assign new work and monitor performance

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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