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As freelancers there are things we absolutely MUST do to protect not only ourself, but freelancers who may be coming up behind us. Freelancers who do NOT do these thing are hurting all of us.

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

VE A CONTRACT FOR ALL WORK! I can not believe how many freelancers do not use contracts. Then along comes somebody who does have a contract and the potential client does a song and dance about how s/he ha

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

Examples of combination products may in

s never used one before and don't you trust them? and so on and so forth. Not only that, but when the job is done .... is it? How many times have freelancers gotten done with a job just to have the client add

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

on to it? Even WITH a contract this will happen. But the difference is that with a contract, you have a legal leg to stand on to refuse to do more work that is not covered in the contract.

LEA

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

VE NOTES This helps not only those who come after you but notes are really for YOU. I know I can work on a project and come back later to do more or change something and can't remember what or how or anyt

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

Combination pro

ing else. I look at the code I wrote and wonder "what was that all about?" Not only that, leave notes for other things such as who created the page and the date. Leave an email address that you know you will

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

have for a long time. so you can be contacted ... unless the client forbids such contact (which should be an alarm bell in your head). Then if you go in and edit the code, leave a note as to exactly what you

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

did and when and why. This keeps a nice trail going for everyone. One note I want to see more people use is the one saying if the client has paid for the service yet. I always put a note in saying "Edited on

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

[date] Paid for on [date]" If the date for paid is blank, then I did not get paid for it or was paid and then blocked before I could put in the date. Either way, the next person looking at it should take that

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

into consideration.

UPFRONT PAYMENT Every once in a while I let this one slide and just about everytime I end up regretting it. Even if you are going to do a month-to-month contract for so

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

ebody, get a "setup" fee or somesuch to start work. If you are being paid by the project, then get at least 25% up front. I recommend 50% upfront, 25% at beta testing, and 25% on completion. When you don't ge

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

Following aspects would a

t an upfront payment, you are taking all the risk on yourself and the client is risk free. An upfront payment ensures the freelancer gets SOME money from the project. Times you can think about not taking an u

dd to the challenges in developing combination products:

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

pfront is on projects that are only going to take you a day or less. Where the time to get the upfront is longer than the time it will take you to complete the project.

DEVELOPMENT SERVER D

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

o all your work on a development server, NOT on the client's server. They may fuss and fume about this, but you are setting yourself up for a real pain in the butt if they refuse to pay. They have the product

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

and you have no leverage other than a drawn out legal battle ... IF you had a contract. There will be some exceptions to this but you have to be careful with it. Like maybe the client is wanting something on

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

Oracle and you don't have Oracle available for development work. Or they are a local company and you can sit in their office and use their equipment for development work.

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

Professional from academic institutions, pharmaceutical industries, health care indust
> Get everything in writing. Email is great for this. Even if you discuss something on the phone or in person, follow up with an email or a letter that details the discussion. Make sure the client signs off o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
n it somehow. I use the email receipt to prove the person has opened the email. That doesn't always work of course but it is a simple way to start out. Of course usually the client will respond that something
.

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
is not right and explain what they think it should be. This shows they read it. If you have ever been in court, you know that being able to show a paper trail is 99% of the battle.

There are m

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

Companies that provide selfless information through particip

any more items to think about and I'm sure other freelancers can add to this with more excellent information. These 5 are what I consider to be the most important areas for protecting yourself as a freelancer

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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