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You have an employee that hasn't improved through discussions and finally decide an official probation period is necessary. Meeting with your empl

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

oyee to discuss probation is only the beginning. Now you both have work to do.

Mark your calendar with every deadline you mentioned in the probat

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

Examples of combination products may in

ion memo. You need to follow-up on each one with your employee. Read my "Tracking Your Employee's Success or Failure" article in this series for m

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

re detailed information. Probation periods are usually 90 days because, over time, that's the amount of time that juries have decided is needed to

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

make a real change in someone's behaviors.

Usually the only shortcut to the full 90 days is if your employee is consistently failing to meet the

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

Combination pro

earlier deadlines, making it difficult or impossible for them to successfully meet all expectations within the 90 days. This isn't an automatic en

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

d to the probation period but it should definitely be part of the follow-up discussions.

At each deadline you have a follow-up meeting with your

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

mployee to discuss whether or not they have met the expectations at that point. Don't move your other deadlines back if they haven't met the earli

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

er deadlines. You need to make it clear that they need to work harder to meet the goals set out in the probation letter.

On the day the probation

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

period is scheduled to end, you must meet with your employee to discuss their status. If they have improved to the level you requested in the prob

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

ation letter, you congratulate them on successfully improving their performance and inform them that their probation has ended. Keep smiling while

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

Following aspects would a

you tell them you expect them to keep up the good behavior!

If your employee has been unable to improve sufficiently, now is the time to end the

dd to the challenges in developing combination products:

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

probation and their employment. Be nice but firm. Tell them they did not successfully complete their probation and you have decided to terminate t

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

heir employment. This is the exit meeting. Have their final paycheck and any other termination paperwork ready before the meeting begins. Keep the

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

meeting short and to the point.

As a side note, I'll make a comment about that final paycheck. I'm a fan of giving two weeks' pay when terminatin

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

g an employee … if you expect to receive two weeks' notice from an employee who is quitting. However, an employee on probation has had 90 days' no

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

Professional from academic institutions, pharmaceutical industries, health care indust

ice so I don't recommend paying for additional time in this circumstance.

If you read this whole series, you'll understand why I mentioned at the

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

beginning that a little time spent communicating with your employees each week can save you a lot of time overall. It's also easier for an employ

.

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

e to continually make small corrections rather than big changes after things become stressful.

Good communication helps build a stronger team and

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

Companies that provide selfless information through particip

improves morale throughout your whole department or company.

This is the last of 7 articles in the Managing Employee Performance Series.

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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