Top Adding - Computers and Technology

If you are thinking about signing up for any training program with a computer training school anytime soon, don't spend a dime unt

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

il you have gone thru this checklist.

1) Objective: I am surprised at number of prospective students who signed up without knowin

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

Examples of combination products may in

why they are enrolling for the certification training program. Just the plain fact that one of your friends is doing it or you ar

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

e in need of job doesn't mean that you should jump in and enroll. Knowing WHY you want to do it and how it is going to help you ac

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

ieve your goal is of paramount importance. So spend some time and ensure you are enrolling for the right reasons.

2) Method of st

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

Combination pro

udy- There are various options out there eg.classroom instructor led training, e-learning, virtual classroom, cbt, self study. Aga

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

n choose the one which suits your personality, budgets etc. Each one has its own merits & a demerit, no one method is better than

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

the other.

3) School: Don't just "Google' it and enroll. Take time out, go and visit the location, check out school facilities, h

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

rdware, financial aid etc.Make sure school is approved by State Body because in case school is facing financial difficulties after

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

enrollment, state body may transfer you to another school without any additional costs.

4) Instructors: Don't be shy about inqui

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

ing about instructor credentials; this is so imperative and critical. Ask about how long person has been training, what their comm

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

Following aspects would a

nication skills are like, have they got real time experience. Ask to see their evaluations from previous classes.

5) Cost of Trai

dd to the challenges in developing combination products:

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

ning: Make sure you get total cost in writing, tuition costs, exam cost, practice exams etc. Make sure that there is no hidden cos

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

s and all inclusive covers everything. Compare costs with other schools offering in the same area. Ask about there retake policy,

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

is there is additional cost for that, when can you take the class again, how many times etc

6) Pass Rate: Ask questions about stu

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

ent's pass rate, how many students have completed the training and have certified. Ask the school to show you the records of how m

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

Professional from academic institutions, pharmaceutical industries, health care indust

any students have passed first time.How does school help if student doesn't pass or is having difficulty in certifying.

7) Refund

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

Policy: Ask to see schools refund policy and if possible speak to students who may have dropped out and have requested refunds. Yo

.

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

u will have a fairly good idea about school refund policy. You can also check with Better Bureau and see if company has any deroga

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

Companies that provide selfless information through particip

ory information listed against them.

Above are few pointers which if followed will save you lot of headaches and grievances later

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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