Subjects - Business

All employers have a duty of care to protect the safety and welfare of all employees whilst at work or conducting activities on behalf of their employer.

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

One of the many areas of health and safety which requires attention is first aid and its provisions to enable the protection of employees in the event of

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

Examples of combination products may in

an injury or emergency situation. All employers no matter how large or small should take the welfare of the employees very seriously with first aid being

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

ne of the highest priorities in protecting their safety.

First aid has been proven to be an extremely useful tool when preventing or assisting injury. In

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 US many states have a programme introduced at school level where students are trained in first aid, this has been proven to have saved many lives and

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

Combination pro

s commended throughout the world as good working practice but unfortunately not all countries such as the US obviously take first aid as being a serious i

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

ssue which can prevent serious injury and even death.

The UK have a legislation requirement named the First Aid at Work stating The Health and Safety Reg

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

lations are that an employer has to provide, as a minimum an `appointed persons’ at all times when employees are at work. An appointed person in the case

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

an be a low level first aider or a fully trained First Aider.

Appointed persons will need to attend a one day training course to learn areas of first aid

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

such as dealing with low level injuries such as cuts, sprains, heat exhaustion, assisting but not dealing with more serious injuries such as breaks, heart

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

attacks etc.

A fully trained first aider at work will consist of completing a four day intensive course including a practical examination. On completion

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

Following aspects would a

of both the training courses the delegate will receive a first aid certificate to prove their competence.

First aiders at work should receive a payment f

dd to the challenges in developing combination products:

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

om an employer for this task but this is not compulsory and this is at your employer’s discretion. The basic first aid provisions should be a good well st

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

cked first aid kit which can be transported easily to the casualty. Requirements on all first aiders are to ensure all that first aid equipment is fully s

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

ocked, in good condition and the expiry dates all checked regularly, the easiest way of achieving this requirement is to compile a first aid box checklist

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

All employers should firstly risk assess areas of working activities to define what level of first aider cover and equipment is required to fulfil the r

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

Professional from academic institutions, pharmaceutical industries, health care indust

equirements of the assessment results. As an example a working area where the potential of an electrical shock from a mains supply to an employee would ba

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

e the assessment of a high risk and the control measures would have to stipulate and ensure the adequate first aid control measures are in place.

Another

.

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

important step in this subject for employers is that they need to compile and communicate a suitable and sufficient policy to cover first aid and its prov

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

Companies that provide selfless information through particip

sions at work.

First aiders at work need to be retrained every three years by a competent service provider, appointed person should be retrained annually

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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