Useful Advices - Business

Sometime soon you will be attending some training. It may be a one hour tele-seminar, a one day class, professional conference, or a weekend retreat. It may be something that you are paying for, or it may be something your organization is investing in. Whether you

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

are paying the bill or not, you are making a significant investment of your time, energy and attention to participate.

Many people approach training as an adult much like they approached classes when they were in school – and those strategies aren’t always the best o

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

Examples of combination products may in

nes to maximize the value from a learning experience. Regardless of the length, situation or topic, there are some very specific things that you can do to convert the experience into useful learning you can apply in your work and life.

Following are seven strategies

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

that you can apply to convert your time and energy spent in training into real useful learning.

1. Have a goal. Been signed up for some training at work? Decided to attend a seminar on a topic you are interested in? Great! The first thing you should do i

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

n any case is set a learning goal. If you are already knowledgeable about the topic and have specific things you want to improve, setting your goal or goals should be easy. If this is training you are less excited about attending, or are unclear about, you can still

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

Combination pro

set a goal like: “Learn one new thing I can apply at work,” or “Meet one person I can add to my network.” Having a goal and writing it down focuses your mind and will help you gain real practical value from any learning situation.

2. Take personal responsibili

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

ty. Take responsibility for your own learning experience. The training may not be the most dynamic or engaging you’ve ever been to, but that is ok, because you have a goal. Make that your focus. Perhaps the trainer isn’t going to cover that topic exactly. That’

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

ok – use their expertise. Ask them at a break, probe for other resources. Stay focused on your goal. Your learning is in your control. Take responsibility for getting from the experience what you want and need.

3. Ask questions. Don’t understand somethi

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

ng? Ask for clarification. Want a little more information? Ask for it. A big part of being responsible for your on learning is asking question to get what you need.

4. Ask the Golden Question. The most important question is the one you won’t likely ask ou

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

t loud. “How can I use what I am learning?” This is the golden question because it helps us translate the learning to real life. Ask this question of yourself through the training experience. I keep a separate place to keep notes on the application ideas I get fro

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

m asking myself this question when I am in training. This truly is the golden question. Ask it of yourself when you start to get distracted, ask it of yourself at breaks. Soon it will become a natural response and an amazingly valuable habit.

5. Learn from ever

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

Following aspects would a

yone. There are more people to learn from than just the speaker/trainer. The other people in the room can be a great way to learn. Tap into their experience and knowledge. Talk to the people at your table or around you. Think of them as peer coaches. These

dd to the challenges in developing combination products:

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

people can help you learn during the session and might become great people in your network after you leave. Be involved, participate and allow yourself to learn from everyone, not just the person in the front of the room.

6. Build an action plan. At the en

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

d of the training, build an action plan. Review your goal(s) and build a plan to implement what you have learned. Reflect on your answers to the golden question and resolve that you will apply those ideas too. If the training has been really valuable, you may have

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

everal ideas. This is great, but be realistic on how much you can apply at a time. Build your plan recognizing that you ay be able to implement some things tomorrow, but that other things might need to be spread out over the next week or more.

7. Teach someone

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

else. If you want to really lock in what you have learned, share what you have learned with someone else. Talk to a colleague back in the office. Share the concepts with a friend. Not only have you helped the other person, but you have increased your mastery a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd clarity of the ideas in your own mind.

Bonus tip # 8 – Review your notes. If you want to really retain what you have learned for the long term, set up a process to review your notes. Review them the evening after the event. Review them the next day, and the nex

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

t day. Then put a note in your to-do list to review them one week later and one month later. Each review only needs to be five minutes long. You are simply trying to build the concepts in your mind through repetition and giving your mind a chance to spark new connec

.

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

tions and new ideas.

As you can see, these strategies don’t require any additional monetary investment, just an investment of your focus and approach. Applying just one of these strategies can have a major impact on your results. Applying them collectively will put

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

Companies that provide selfless information through particip

you among the learning elite.

Put these strategies some where so that you can review them before you attend any training event. Over time the reminders will turn these strategies into your own habits – habits that will help you move towards your goals and potential

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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