Summary - Relationships

1. Keep a journal to document feelings, thoughts, and growth during this exercise. Journal each night and document your exper

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

ience during this process.

2. Shift your focus inward- Tune into your own feelings. By noticing what thoughts and feelings co

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

Examples of combination products may in

e up during the day: we experience a wide range of feelings during the day take note!

3. Choose one relationship to focus on

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

for the next 2 weeks- it may be your relationship with your boss, your significant other, or friend.

4. As you are paying clo

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 attention to this relationship survey the quality of your interaction: a) what kinds of feelings come up b) how do you feel

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

Combination pro

hen you leave an interaction with this person c) do any pet peeves or hot buttons get pushed, if so which ones.

5. Identify y

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

our personal needs (i.e. being loved, recognized, correct, valued, acknowledged, respected). Are your needs being met? (Hint:

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

When you do not get our needs met, you are running on empty looking to others to fill you up which may cause conflict.)

6. M

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

ake a list of the feelings that have come up during week one and make a second list of the needs you have identified. Compare

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

he two lists. Determine whether there are any connections between your feelings and your needs. Make a commitment to work on

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

he areas where your needs and feelings meet.

7. Be compassionate with yourself. Often, we need to work on the same issues ma

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

Following aspects would a

ny times. Beating yourself up because you haven't made the progress that you would like disempowers and discourages your effor

dd to the challenges in developing combination products:

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

s to move forward. In addition, it is not uncommon to feel as if you are finished with an issue only to have it resurface. Wh

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

en this happens, simply acknowledge, accept, and make choices about how you want to proceed.

8. Communicate your feelings as

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

means of improving the relationship. Open a dialogue using I statements, i.e. I feel annoyed when you consistently draw atte

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

tion to my age because it is a sore subject for me. Or I appreciate it when you ask how my career is going.

9. Maintain your

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

Professional from academic institutions, pharmaceutical industries, health care indust

balance- respond rather than react. It is easy to fly off the handle especially when someone hits one of your sore spots. Ra

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

her than risk damaging the relationship, take a deep breath and a moment to think about what the best course of action or commu

.

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

nication will be.

10. Embrace your personal power- by honoring yourself and your values. If you value respect, honesty, and

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

Companies that provide selfless information through particip

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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Summary - Ten Steps to Understanding and Using RR's (Relationship Reflections)

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