Advice You - Business

Firing, sacking, letting go or terminating people is unpleasant. There are ways to minimise resentment, but why bother? Because most legal action and unpleasantness stems fro

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

m dissatisfaction/resentment about the way things were handled - about how rather than what happened. Dismissal can be unfair because of the reason, or the way it was done, s

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

Examples of combination products may in

o you need to be extremely careful. In the law regarding employer-employee relationships, fairness is key. You must be fair, and be seen to be fair. But fairness, like beauty

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

is in the eye of the beholder - after being terminated, very few people have clear vision!

Prepare a disciplinary process/policy given to all, with a sequence of verbal the

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

n written warnings ending with dismissal. Ensure processes allow for discipline/termination on grounds of both performance (capability) and attitude (conduct). Specify your r

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

Combination pro

ght to instantly dismiss someone (summary dismissal) for gross misconduct, and give guidance on what would constitute this.

Have hard evidence to back up all decisions. Docu

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

mentation of poor conduct and/or capability is essential. You have to follow your own process to avoid legal unfairness. Negative appraisals/reviews make good evidence.

Neve

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

take decisions lightly - weak performance can sometimes be improved by skilled intervention/support. Termination is traumatic/demotivating for surviving staff, even when the

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

y understand why.

Avoid surprises by giving every opportunity for improvement before opting to terminate. This reduces grounds for legal action. Plus, survivors feel less th

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

eatened if they see you are fair. Employees who have been aware for some time there is a problem are usually less traumatised, and may already be looking elsewhere. Always av

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

oid firing someone who has no idea its a possibility, except for summary dismissal.

Get legal advice if you have any questions. Balance ?200-500 for advice against ?50,000 m

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

Following aspects would a

ax unfair dismissal compensation! Phone lawyers and ask for advice on dismissal - sometimes possible over the phone for a fee. Remember, sexual/racial discrimination compensa

dd to the challenges in developing combination products:

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

ion is unlimited, so always take legal advice if this might be alleged, whether or not it happened.

Plan your speech exactly and write out a script. It ensures you say every

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

thing necessary, and helps if you get stuck. There can be temptation to offer sympathetic/reassuring words to sweeten the message. Unfortunately, kindness here can cause conf

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

sion and lead to legal action. Have a witness present - never fire one-to-one.

Stay calm - never act in anger. Even summary dismissal can be done after an hour to prepare an

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

d calm down. If employees lash out verbally/physically, don't respond. Get it right, and this is the last time you will deal with them - they will no longer be your problem.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Be humane - treat people sympathetically if possible - without conveying anything positive about conduct/capability. They are losing their job and income. They are frightened

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

, angry, upset, devastated - and you have to deal with it. Sympathise with their predicament without commenting on the cause. Being calm and softly spoken can negate trauma.

.

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

t also decreases unpleasantness - it's harder to abuse someone who is being nice to you.

Recommended action: · Have a policy, publicised to all staff, and signed for receip

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

Companies that provide selfless information through particip

t by all.

· Have the policy legally checked by an expert.

· Always prepare.

· Remember the way you terminate someone can be legally unfair, even if the grounds are perfect

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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