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More than a few dozen times, people say to me, 'I don't know how you fit it all in!' Sometimes even "I" don't know how I fit it all in, to be honest. However, not only did I realize early that if I wanted to accomplish the things in my life 'to

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

do' list, I'd better take control of my time. I have learned that time management is a huge issue with many of my clients. So, to help with this common problem, below are some tips to at least get you started on how to make the most out of you

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

Examples of combination products may in

limited resource: Time.

Prioritize
What do you want to accomplish? Many people I work with have a HUGE list of what they want to do or of opportunities coming their way. It becomes so overwhelming for them that they find thems

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

lves doing NOTHING! Now, that defeats the purpose of having such great opportunities at their feet, huh? So, make a list of all the things you would like to do or accomplish, or all the opportunities coming your way, and then prioritize them. F

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

r example, which of all the things you listed above is the very most important to you to make happen? Then that would be Number 1. Continue this until you have come to the last one. The last item on your list should be what you could put off un

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

Combination pro

til last.

Make a list
I could not function through each day without my daily list! Not having my list is like walking into a Williams-Sonoma store without a shopping list. I guess it would be what walking into a toy store would

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

be like for a kid. I don’t know where to start, there are so many wonderful things to see and do! So, usually the night before, I will write down the tasks that need attending to the next day. Generally my list is related to what I have on my m

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

rketing calendar, which helps me organize my entire month. Sometimes, I will create a weekly list, and then break it down from there. Determine what works best for you and put your list together. If you're not used to writing down lists, just s

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

art with writing down a few important things. Maybe you want to make some phone calls tomorrow; write that down. Perhaps you’ve been meaning to write an article; write it down.

Map it out
Having many things to do in the course

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

of your day can also lead to getting nothing done. We've all been there; we have this small project to complete, another to start, we have to be done with either by noon to pick up the kids, then of course there is bed and relaxation time. But

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

oon things aren’t getting done. Or, we want to start a new project (like start our own business!) and we have no CLUE how we'll fit that in!

Here is a tip that I learned long ago to help: Print up a schedule that breaks down the day, by th

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

Following aspects would a

hour, for a whole week. First shade out the time you sleep, then the time you spend on self-care to get ready for the day and for bed. Then shade out family time; this includes meals, watching movies, helping with homework, etc. If you work, s

dd to the challenges in developing combination products:

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

ade that time out, including commuting time. Also include self care for just you, such as exercise or relaxation time. Then look at the time you have left. You may be amazed at what you find! One client realized that a HUGE chunk of her time wa

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

s taken by her part-time job that included a long commute time, which prompted her to consider how she can change that.

Once you have mapped out your time, then determine what projects are important (from your priorities list) and determin

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

how you will accomplish them.

Clean up
Is your work space clean and organized or cluttered and out of control? How is your filing system? Did you know that when your work area is cluttered and feeling out of control that YOU f

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

el cluttered and out of control? So, look around and decide where you stand in this area. We've just added something NEW to add to your priority list, however! But the good news is you've also just investigated where you have time to work on pr

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

Professional from academic institutions, pharmaceutical industries, health care indust

jects! So, add this to your priority list and then schedule it into your calendar. However, because this can be overwhelming, pick a specific area you want to work on. Let's say you live in piles. On your priority list, break down that 'big' it

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

em of 'clean office' into small projects. For example, put 'clean up one pile' if you have piles of papers. If you want to organize your files, pick just one drawer at a time to focus on. If you have allowed two hours to work on this project an

.

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

you aren't complete at the end of two hours, just pick up on the day you have again allotted time to work on that project!

These are just a few of the simplest ways to help you organize your time. I often use these as beginning steps for

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

Companies that provide selfless information through particip

lients and they find they help in more ways than they ever imagined! From there, anything is possible! Now you can set up your goals for your life or business and actually get them done! Ok, now, time to stop reading and start getting organized

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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