Answers - Relationships

Ever notice that you get into a fight or argument with your beloved on Valentine’s Day? Somehow on the most romantic day of the year, you end up having a heated discussion w

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

hen you had expected a romantic candle-lit dinner. Here are some tips for negotiating with your Valentine this year.

1. You Don’t Have To Be Right to Settle

Did you know

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

Examples of combination products may in

hat there are three words we want to hear, even more than “I love you?” We love to here those three magic words, “You are right.” For some this is even harder to say than “

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

love you.” And if you say, “You are absolutely right”, that is even sweeter. When someone says, “It is the principal that counts”, that usually means that being right is mo

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

e important that resolving the dispute. You have to get beyond who is right and who is wrong and get to what is going to resolve the negotiation. Feeling that you are right

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

Combination pro

an be a heady emotion, but it has no place in a negotiation, especially with a loved one. Try saying, “You are absolutely right” and see what happens.

2. Don’t get distract

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 by your emotions.

This may be sound contradictory but negotiating with your spouse or loved ones can sometimes be more difficult that negotiating with business colleagues

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

It is easier to get your feelings hurt because of the emotional investment in the relationship. If you want to have a successful Valentine’s Day, it is important to check

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

our emotions at the door, even if you are upset about something your spouse has said or done. You need to get past this stage if you are going to have a nice Valentine seaso

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

. Try to put those feelings of anger or resentment aside for a couple of days. You can always revisit those issues in March.

3. Look Forward Not Back. The Past Is Called Th

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

Past For A Reason

Do you ever notice that sometimes negotiations with loved ones tend to be the same argument over and over? Valentine’s season is not the time to dredge u

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

Following aspects would a

p old disputes. The past is the called the past for a reason. Refraining from bringing up those past arguments will help you stay in the present. If your loved one is too in

dd to the challenges in developing combination products:

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

olved in the past, get them into the present by asking them what they want now to resolve the dispute. By staying in the present, you will have a better chance of resolving

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

oday’s negotiation.

4. Familiarity Can Breed Contempt

Sometimes the parties know each other so well that they use that information against each other and push each other’s

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

buttons. This is one reason we have the same arguments over and over. This is called passive hostility. Sometimes we will say something just to get a reaction just because 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

can. Refrain from baiting your loved one. If your loved one is doing this to you, you need to put a stop to it. Point out what he or she is doing. Ask them for a truce dur

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng Valentine season and see what happens.

5. Lower Your Expectations

One reason that romantic plans go awry is that the expectations are too high. First of all, if there i

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

something you want to do or somewhere you want to go, let your Valentine know. Don’t expect the other side to be a mind reader or you will likely be disappointed. If you wa

.

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 to go to a particular restaurant, offer to make the reservations or drop some hints. If your goal is to have a pleasant evening with dinner and a movie, you can probably a

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

Companies that provide selfless information through particip

hieve that. If your goal is to have the most romantic evening of the year, you will inevitably be disappointed.

I hope these tips will help you have a great Valentine’s Day

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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