Useful Advices - Business

We are coming up to the end of the year and the time when many of us look to clean out the clutter in the office. It may be just 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

fill the time during the slow holiday week but it can also be an opportunity to practice good document retention practices.

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

Examples of combination products may in

> Most offices have a retention policy for official company records, i.e. tax returns, employee files and bank statements. These d

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

cuments are carefully filed and stored neatly in boxes in a storage area or at an offsite storage facility. Each box is labeled wit

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

h the owner and the year of the document. Every year a shredding service comes in and shreds the outdated records.

This is a great

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

Combination pro

system for the official company documents but what about the secondary records in the office? Secondary records are everything that

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

employees keep stashed away in their desks and in filling cabinets around the office. They can be customer lists, memos, printouts

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

or even copies of official company records. It is these records that make up the bulk of the documents an office produces.

Don't

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

hink you need to worry about these old meeting minutes and customer lists? Don't forget that if you allow your employees to treat t

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

his information as trash you have no legal recourse under Corporate Espionage Act if it is given or sold to your competitors. It is

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

also these documents that show up at the most inopportune times. Disgruntled employees often times save these records only to produ

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

Following aspects would a

ce them for the plaintiff in a lawsuit.

A good records retention policy should cover secondary records and provide for reasonable

dd to the challenges in developing combination products:

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

life spans. Employees should be encouraged to regularly shred documents past their usefulness.

As your employees clean out their d

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

sks this month why not bring in a shredding service and hold a paper shredding day? Provide everyone with the company's retention g

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

uidelines and encourage them to clean out their desks and file cabinets. Have shredding bins located around the office so everythin

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

ends up in the shredder and not in the trash. Not only do you increase security but the paper is recycled.

You might also conside

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

Professional from academic institutions, pharmaceutical industries, health care indust

r allowing each employee to bring in a box of shredding from his or her home. Let everyone know you would like them to bring in any

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

paperwork they have taken home but they are welcome to fill up the box with any other shredding they need done. This not only help

.

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

protect your employees from identity theft but also helps you to better control your company's information.

Employees will apprec

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

Companies that provide selfless information through particip

iate a break from slow home shredders and it is an inexpensive perk. The incremental cost to have an additional box shredded is low

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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