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People management and leadership has become a major topic of conversation in today’s market place and have assumed mythical qualities. Managing you peopl

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

e is not that difficult if you are willing to invest one thing in their development; YOU.

The emotional cost and some simple training and mentoring can

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

Examples of combination products may in

ee you be a successful leader and manager.

As a previous CEO of companies (before starting Biz Momentum) I proved this time and time again and often baf

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

led and confounded those that wanted to make the whole leadership thing complicated!

What’s it all about!!

1. Managing your people is largely COMMON SE

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

SE

2. Leaders don't wait for others to show the way.

3. Leaders participate in the workplace and are seen doing the hard yards, leading by example we u

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

Combination pro

ed to call it.

4. Leaders inspire other people through authenticity (Random Acts of Kindness, Mentors not Tormentors)

5. Leaders know their people - Mo

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

ther Teresa took the time to know her 700 sisters? It’s all about choice. As for your people, do you now their partners and children’s names? do you know

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

what is important to them?

A Metaphor - Motor Vehicle - How do you treat your car?

Most people put more positive effort into servicing their motor vehi

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

les than taking the time to fine-tune their employees.

• Get to know your car
• Get used to driving it
• Servicing it
• Recognising the d

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

fferent noises – timing chain
• Know when its time to replace, upgrade or keep it

A. What has this to do with employees?

Sign the Contract
En

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

ure you employees have a valid Employment Contract

Fuel the Car - Empower your people
A comprehensive ‘job description’ and let them do the job

T

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

Following aspects would a

ake out Insurance
Induct your employees – let them know their responsibilities and rights

Insurance – might have ‘an excess’ – MULTI-SKILL

Mainten

dd to the challenges in developing combination products:

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

nce
Show genuine interest, Develop Listening Skills

Regular Service
Conduct regular performance management appraisals that are highly interact

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

ve and positive? Take the time or do the crime. Neglecting to performance manage you employees takes the agenda largely out of your hands and into their

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

in times of strife.

Regular Inspection
Being a peacemaker not a peacekeeper. A peacemaker makes peace! A peace keeper constantly keeps warring sid

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

apart - there is no peace just the appearance of peace.

Go for a Joy Ride Celebrate successes and Learn to have fun in your business.

THE LAW OF UNIN

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

Professional from academic institutions, pharmaceutical industries, health care indust

TENDED CONSEQUENCES

(Phil’s law of unintended consequences)
You don’t intend to fail; however, the choices you make today will determine where you

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

re placed tomorrow. Each choice builds on another and all of a sudden you have a foundation – good or bad – your decision my decision.

You cannot escape

.

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

your responsibility to manage your people or they will manage your time and you.

People who feel and are genuinely valued are priceless and add great va

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

Companies that provide selfless information through particip

ue to your business.

The ball is in your court!

For more helpful information visit www.biz-momentum.com you can sign up for our free monthly newsletter

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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With the price of plastic so volatile, here are 7 ways to avoid or even eliminate price increases on batch inclusion bags.

Investors, like the rest of us, have different tastes. One investor may love a concept and/or business plan while the next may hate both. It is important to understand this as business plans are working documents and are always undergoing iterations.

The job market is becoming increasingly complex. The healthcare field struggles to attract and maintain qualified employees. Educational institutions face the consequences of high turnover rates and difficulties in satisfying overworked, weary teachers.

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