Advice You - Business

People naturally include trust and respect in their list of important values. Yet so often, at all levels, people complain that they are missing.

Every human is a sovereig

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

n entity and is owned by nobody. Nothing but force can change that. Therefore people will choose to follow only those whom they trust and respect.

Trust and Respect are ear

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

Examples of combination products may in

ned by the consistent correct practice of value-based behaviour, including: -

Treating all others as if they would wish to be treated. Being the behaviour they seek from ot

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

ers. Listening to what others have to say. Honouring others right to an opinion. Honouring all agreements whether written or spoken. Encouraging and facilitating others to c

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

ontribute to the shared values vision goal or task. Recognizing and acknowledging others'achievements. Owning up to errors and omissions and rectifying them promptly. Not ac

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

Combination pro

epting unacceptable behaviour, yet remaining respectful of the individual. Distinguishing between respect and popularity. Ensuring one's ego is aligned to the shared values

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

and vision. Honouring all others' sovereignty of their self. Being inclusive. Not wasting energy on blaming. Remaining as calm and centred as possible. Realising that trust

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

and respect is earned by first giving trust and respect.

Whilst the above list may appear difficult to remember and practice, it can be reduced to four particular understan

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

ings and thus easier to live. The understandings are: -

"We each are sovereign entities and no matter what our behaviour is, we are not the behaviour performance or outcome

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

s, therefore we deserve to be treated respectfully at all times, no matter what."

"Recognize and immediately acknowledge desirable behaviour, performance and outcomes, and

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

o not accept unacceptable behaviour, performance or outcomes."

"You can deal with the unacceptable by asking respectful, timely and appropriate questions that brings acute

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

Following aspects would a

awareness to the perpetrator and influences remedial behaviour"

"Your consistent open respectful behaviour is the central pillar of trust"

When you show others that you co

dd to the challenges in developing combination products:

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

nsistently respectfully deal with great as well as unacceptable behaviour, performance and outcomes, they will naturally reciprocate by improving their behaviour, performanc

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

and outcomes. Such is the power of trust and respect.

If you have lost the respect of others, they will only follow you because they fear something or someone, and they ar

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

e unable to be their best. They will not trust you either.

Recovering trust and respect is difficult and yet very achievable and requires the following: -

Courage to do w

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

at is necessary. Owning up to the breach. Rectifying the breach. Committing to rebuild trust and respect. Actively monitoring one's own behaviour to ensure trust and respect

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

Professional from academic institutions, pharmaceutical industries, health care indust

is not further breached. Consistent appropriate behaviour that earns trust and respect.

Respect and trust go hand in hand. When they are not present at desired levels, the

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

following are the symptoms in an organization or relationship: -

Withheld and broken communication. Integrity breaches e.g. disobedience, absenteeism, safety breaches, and

.

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

lesser performance. Lowered morale and increased distress. Departure of talent.

Can you imagine the loss of productivity efficiency and profit directly caused by diminished

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

Companies that provide selfless information through particip

trust and respect?

Can you imagine the return on investment for proactively improving trust and respect in your workplace?

Are you trusted and respected in your workplace

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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