I Advice - Writing and Speaking

After the publication of my first book, I started experiencing a new phenomenon in my life. In fact, it probably started before the publication, but became more frequent when I began my promotio

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

nal tour.

People love to imagine themselves as writers. They want to write books. I’m excited by that. More and more people are approaching me for advice about writing. Books are in my top t

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

Examples of combination products may in

n favorite things and I can’t get enough. I love to encourage and support writers. However, I don’t think that the people who approach me really believe they can do it.

While I am looking forw

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

rd to what these people want to put in print, I have a nagging feeling that their stories will never be published. Why? Because no one has ever passed the hand test. Every time someone asks me

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

about writing, self-publishing, organization, processes, or anything else, I look at their hands. For me, the sign of a writer is the constant presence of a pen and paper.

I have carried a lit

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

Combination pro

le notebook and pen everywhere for as long as I can remember. Whether I use it to scratch out a grocery list, scripture references, or a “to do” list for work doesn’t matter. The notebook is al

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

ays in use and constantly referred to when I am writing, which I do every day.

It is disheartening when a potential author approaches me, asks for advice, and then asks me to write it all down i

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

n my notebook! In fact, I have started to leave my notebook in my briefcase or purse when I am talking to people. To me, empty hands means that you are not expecting me to say anything importan

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

. When I see empty hands, I know that my notebook can stay put because the exchange is for entertainment purposes only.

I like the idea of mini-celebrity, but I like the idea of sharing even mo

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

e. My nature is that of an educator/entrepreneur. I love to learn things and share them. I do this mostly through writing and speaking. The constant presence of my notebook reflects my deep b

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

lief that valuable information is everywhere and I don’t want to miss anything. I don’t like the idea of a notebook-free experience.

Another strong belief is that everyone has an interesting st

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

Following aspects would a

ory. Asking questions about how to write them and publish them are important. It is especially important to ask those questions to people who are experienced, so please grab the opportunity whe

dd to the challenges in developing combination products:

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

ever it arises. We are writers, we love to tell stories and break down processes! We are also very likely to do present the topic in articles or workshops. But, we have to draw the line at wr

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

ting down dates and titles for you.

I am trained as a psychologist. You can trust the three Ivy League graduate degrees that inform these very basic conclusions. Every writer wants fans. We l

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

ike to believe that someone is relating to us and that our message has been conveyed clearly enough for people to understand. We love to see your approach because it means that our skills are in

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

act. So please, never hesitate to walk right up.

Your desire to relate is equally compelling and relating on a professional level is a widely accepted practice. “I write, too” is great way to

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

Professional from academic institutions, pharmaceutical industries, health care indust

ake contact. After that, it is perfectly alright to change the subject or go further. If you just want social or professional contact, make it plain. Let’s exchange cards and go on with it. B

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

ut, if you ask for advice it is a reflex for me to look at your hands and make a judgment call. Sorry, but its happened enough for me to have to make a choice about my response.

I want everyone

.

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

to live as full a life as they can. I want to spare you the troubles that I have endured. I want to give you the real deal. But no one wants to waste their time. When your inner conflicts are

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

Companies that provide selfless information through particip

resolved, your confidence is intact and you truly believe that you are approaching a person who has information that will take you one step closer to your dream, you will have your notebook ready

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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The traditional linear approach in solving problem has limited use, especially when you are under pressure to generate innovative solutions. Using creative thinking technique such SCAMPER, you will be able to adopt a new approach in managing your next problem solving session.

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