Digg It - Internet and Businesses Online

This article introduces the Data Protection Act 1998 - does your business comply?

What is Data Protection?
Data Protection is the area of Law that Governs what may or may not be done with personal informati

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

on. Such personal information may be in manual (hand-written, print outs etc) or electronic (Stored on a computer) form. It applies to the processing of personal data by “Data Controllers”.

Understanding the te

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

Examples of combination products may in

rms used.
1. Data Controller – any person/business who controls processing of personal data.

2. Personal Data – information (electronic or manual) which identifies a living individual. For example your name

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

, address, Credit Card, DNA, finger print, email address.

3. Processing – any activity that can be carried out on personal data. For example obtaining, storing, copying and transferring. So what does the act do

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

?

The Act can be broken down into three different functions:-

1. Notification - It requires every Data Controller to notify the relevant national authority of its processing operations.

2. Code of conduct – It

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

Combination pro

obliges Data Controllers to comply with the “Data Protection Principles”, a code of conduct.

3. Individual Rights – It create a set of enforceable rights individuals can expect in the processing of their person

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

al data.

Notification.
The information Commissioner must be informed of the types of processing that Data Controllers are undertaking. Notification can be done in writing using the correct forms or online h

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

ttps://forms.informationcommissioner.gov.uk/cgi-bin/dprproc?page=7.html it currently costs ?35 per year to register. There is a register available of all Data Controllers, it is a public document and can be sea

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

rched online at http://www.esd.informationcommissioner.gov.uk/esd/search.asp

There are a few exemptions for the need to notify the Information Commission. Examples are employee records, membership or customer li

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

sts.

Data controllers should check if they are exempt as it is a criminal offence to process personal data without notification or to process data differently to the type notified.

Code of Conduct
There ar

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

8 principles of good information handling or processing. These can be seen as a Code of Conduct Data Controllers must comply with unless there are exempt.

These principles require the data controller to:

1. Pr

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

Following aspects would a

ocess personal data fairly and lawfully.

2. Obtain personal data only for one or more specified and lawful purposes and to ensure that such data is not processed in a manner which is incompatible with the purpos

dd to the challenges in developing combination products:

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

e or purposes for which it was obtained.

3. Ensure that personal data is adequate, relevant and not excessive for the purpose or purposes for which it is held.

4. Ensure that personal data is accurate and, wher

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

e necessary, kept up to date.

5. Ensure that personal data is not kept for any longer than is necessary for the purpose for which it was obtained.

6. Process personal data in accordance with the rights of the i

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

ndividuals to whom the information relates.

7. Ensure that personal data is kept secure.

8. Ensure that personal data is not transferred to a country outside the European Economic Area unless the country to whi

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

ch the information is to be sent ensures an adequate level of protection for the rights (in relation to the information) of the individuals to whom the personal data relates.

Individuals’ Rights.
The Act sa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ys that individuals have certain rights with respect to personal data that someone else holds about them:

1. To be informed by any data controller whether it is processing data concerning him, and to be given a

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

copy of such data.
2. To prevent processing likely to cause him damage or distress.
3. To prevent direct marketing to him.
4. To prevent the taking of automated decisions concerning him.
5. To

.

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

have inaccurate data corrected or erased.
6. To compensation for damage or distress caused by unlawful data processing.
7. To ask the Information Commissioner to investigate the activities of any data

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

Companies that provide selfless information through particip

controller.

Summary.
Data controllers holding personal Data must comply with the 8 principals of good information handling. Individuals have the right to see that data and have it changed if it is incorrect

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/50461/diggit-Do-you-Comply-with-the-Data-Protection-Act.html">Do you Comply with the Data Protection Act?</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/50461/diggit-Do-you-Comply-with-the-Data-Protection-Act.html]Do you Comply with the Data Protection Act?[/url]

When it comes to some of the most uncomfortable situations and discussions that arise in the workplace, mulling over the issue of your salary might be one of the most intimidating and stressful topics to deal with.

If you are considering living permanently in Spain, you must register both yourself and any dependants with the local Police Station and obtain a NIE certificate (Numero de Identificacion de Extranjeros) - Foreigners Identification Number. This certificate should be carried on your person at all times, together with your passport or residents' permit. Once you have this certificate, any EU national looking for employment should present himself to the nearest office of the INEM (Instituto Nacional de Empleo) - Unemployment Office, to register as a 'demandante de empleo' - unemployed.

What is it like from a marketing perspective to be yesterday’s news? We rely on what is tried and true in marketing because it is usually safe, tried, and tested. This article shows you 15 ways to become a forward thinker and stay in today’s news.

Tags

Links

Digg It - Do you Comply with the Data Protection Act?

Related Articles: