Useful Advices - Business

This morning, I read about a company using on-line auctions to defraud customers. Last week, I consulted on an ethics complaint where a business coach betrayed a client’s confidentiality. And, recently a Physician was convicte

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 of insider trading based on information from a patient, a violation of both business ethics and her professional ethics.

Business ethics are the key to profits. If clients and customers don’t trust you, and your business et

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

Examples of combination products may in

ics, they will not do business with you. Would you buy from a company you didn’t trust? Of course not!

Business ethics have become a hot-button topic. There are often ethical conflicts between making money, and doing what is

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

ight. There can be dilemmas about doing what is best for your employer, what’s best for your own career, and what’s best for the customer. Business ethics is about negotiating these mine-fields. Here are my Top 10 Principles f

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

r Positive Business Ethics:

1. Business Ethics are built on Personal Ethics. There is no real separation between doing what is right in business, and playing fair, telling the truth and being ethical in your personal life.

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

Combination pro

2. Business Ethics are based on Fairness. Would a dis-interested observer agree that both sides are being treated fairly? Are both sides negotiating in good faith? Does each transaction take place on a “level playing field”?

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

If so, the basic principles of ethics are being met.

3. Business Ethics require Integrity. Integrity refers to whole-ness, reliability and consistency. Ethical businesses treat people with respect, honesty and integrity. Th

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

ey back up their promises, and they keep their commitments.

4. Business Ethics require Truth-telling. The days when a business could sell a defective product and hide behind the “buyer beware” defense are long gone. You can

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

sell products or services that have limitations, defects or are out-dated, but not as first-class, new merchandise. Truth in advertising is not only the law, business ethics require it.

5. Business Ethics require Dependabili

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

y. If your company is new, unstable, about to be sold, or going out of business, ethics requires that you let clients and customers know this. Ethical businesses can be relied upon to be available to solve problems, answer qu

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

stions and provide support.

6. Business Ethics require a Business Plan. A company’s ethics are built on its image of itself and its vision of the future and its role in the community. Business ethics do not happen in a vacu

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

Following aspects would a

m. The clearer the company’s plan for growth, stability, profits and service, the stronger its commitment to ethical business practices.

7. Business Ethics apply Internally and Externally. Ethical businesses treat both cust

dd to the challenges in developing combination products:

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

mers and employees with respect and fairness. Ethics is about respect in the conference room, negotiating in good faith, keeping promises and meeting obligations to staff, employers, vendors and customers. The scope is univers

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

l.

8. Business Ethics require a Profit. Ethical businesses are well-run, well-managed, have effective internal controls, and clear expectations of growth. Ethics is about how we live in the present to prepare for the future

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

, and a business without profits (or a plan to create them) is not meeting its ethical obligations to prepare for the future well-being of the company, its employees and customers.

9. Business Ethics are values-based. The

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

aw, and professional organizations, must produce written standards that are inflexible and universal. While they may talk about “ethics”, these documents are usually prescriptive and refer to minimal standards. Ethics are abou

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

Professional from academic institutions, pharmaceutical industries, health care indust

values, ideals and aspirations. Ethical businesses may not always live up to their ideals, but they are clear about their intent.

10. Business Ethics come from the Boss. Leadership sets the tone, in every area of a busines

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

. Ethics are either central to the way a company functions, or they are not. The executives and managers either lead the way, or they communicate that cutting corners, deception and dis-respect are acceptable. Line staff will

.

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

lways rise, or sink, to the level of performance they see modeled above them. Business ethics starts at the top.

Ethics is about the quality of our lives, the quality of our service, and ultimately, about the bottom line. An

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

Companies that provide selfless information through particip

unhappy customer complains to an average of 16 people. Treating employees, customers, vendors and the public in an ethical, fair and open way is not only the right thing, in the long run, it’s the only way to stay in business

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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Most every state, as well as the U.S. federal government, have police seizures laws that empower a law enforcement agency to seize property that was either used in the commission of a crime, or was purchased with money that was received through the commission of a crime.

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