Suggest - Relationships

1. Prevent silence by developing a safe environment:
Silence can occur when a person does not feel it is safe to speak out. Create an environment that invites p

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

articipation and in which people feel comfortable to talk. An environment where people can talk, be listened to and understood - free of judgement, accusation, blame, bel

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

Examples of combination products may in

ttling, derision or sarcasm. This may reduce the times they need to go silent.

2. Prevent silence by LISTENING and not jumping in:
Pause before responding

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

and then respond by feeding back what you have understood. Listen rather than offering advice, solving the problem for them, intellectualising, ridiculing, disagreeing, p

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

acifying, relating similar stories ... and so on. Simply be there with them. This will make it feel safer so silence is not necessary.

3. When you are getting al

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

Combination pro

ng talk about what happens:
When you are getting along talk about the silences that occur. Work out two strategies. Firstly, what you can do to help to stop silenc

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

from happening and secondly, ways that help dissolve silence when it does happen.

4. When someone is silent gently comment on what you've noticed:
Gently

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

mention the silence. Without judgement or complaint comment on what you've noticed. For example, "I've noticed you are quiet at the moment, how are you feeling?" rather

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

han a challenging question, "So what's wrong with you?"

5. Ask: "how can I help", or "what do you need?"
Don't assume you know what silent people need, as

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

them. Ask the person how you can help or what he or she needs. For example, don't automatically assume they want an arm around their shoulders, or a cup of tea or to tal

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

about it. Don't give advice or solve their problems unless you know that is what they want.

6. Provide options of 3 possibilities:
Provide different opt

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

Following aspects would a

ions of help. "Would you like me to leave you in peace, bring you a cup of tea or give you a hug?" This is different from saying, "Here have a cup of tea". Don't trap the

dd to the challenges in developing combination products:

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

into accepting something. Gentle suggestions can help them to respond.

7. If the person says something, ACCEPT it:
Accept what the person says. Don't ju

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

ge. Don't tell them what to do. Don't tell them to stop feeling like that. Don't tell them they need to change. Don't fire questions at them and don't argue. For example,

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

if they say, "I'm so worried about Billy" say, "so Billy being sick is getting you down?" or "Billy being sick is worrying". This is instead of more judgemental respons

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

s, such as, "You know he is going to be alright", "Silly thing", "You should go and ask the Doctor how he is", "Oh, is that all", or "Why on earth are you worried about h

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

Professional from academic institutions, pharmaceutical industries, health care indust

m?"

8. Go Slowly:
Go slowly and gently. Allow quiet between you, pause before responding, reflect. Go closer in stages, not all at once.

9. Speak Gent

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

ly:
Speak with a softened, pleasant tone of voice, and a clear voice, with an easy rate of speech. Don't speak in a harsh, tense, whiny or fast way. Sound quiet,

.

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

alm and patient.

10. Don't push for a response:
Don't hound them for an explanation; if you do they may retreat even more. Be sympathetic. In a kindly, u

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

Companies that provide selfless information through particip

derstanding, easy way be on their side and be interested in what is going on. Demonstrate an attitude of wanting to listen to them. Put aside your own issues for now.

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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