Advice Pool - Reference and Education

When starting a career in any sector of business, whether it be the private, public, or non-profit making sector, or an entrepreneurial business, it is essential to have a strong foundation of business and management knowledge. The purpose is not to give you a specialist level of expertis

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

e, for example in Human Resources, Finance, or Quality Management. Rather it is to provide you with a sound, all-round understanding of the key areas of business and management.

Two outcomes should be the result of studying this type of course. Firstly, you will have sufficient knowledge

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

Examples of combination products may in

and awareness of a range of disciplines, so that you can make effective operational contributions to activities and discussions in these areas. Secondly, you will have enough information to make a decision about which area to specialise in, or if you decide to remain a generalist, which a

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

eas to take further studies in.

For those just starting, or in the first few years of work, selecting a first, introductory, foundation level course of study is a critical step. If the selected course, and qualification, is not the most appropriate one, this can have an highly negative i

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

pact on the early stages of the student’s career development. Despite the apparent attractiveness of the more glamorous and “cutting edge” titles, such as “E Business”, “Network Technology”, “Systems Analysis” and “Website Design”, gaining a qualification with any of these as the main ti

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

Combination pro

le, or one of your main study options, will in reality be damaging in most cases. Potential employers, and current ones, will not be impressed by such qualification titles. Even in niche business sectors, such as internet or design related ones, employers will be more impressed with young

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

applicants who have a solid, all-round, broad understanding of the key functional areas of business. Experience, talent, specific skills, in the technical areas are, of course, highly valuable, but most employers will be looking for people who are able to contribute to all the main opera

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

ional activities. Take for example, website design. Unless you plan to, and are 100% certain, that this is where your career path will take you, taking this as a study option is a complete waste of time. Learn Dreamweaver, yes. Take website design as an area of study in your foundation b

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

siness course? No.

Equally important in this argument is that of job and career changes. In today’s business world it is now accepted that most younger people will, during their lifetime at work, change jobs many times, and change careers, or business sectors, at least four times. With s

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

many changes of direction in mind, it can only be good sense, for those seeking their first, foundation level qualification, to study and qualify in the core areas of business activity. Then, when moving into a new role, or applying for a position in a different business sector, the broa

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

based qualification, and study content, will be an asset. You will have experience to offer from your time in other areas, but your qualification will be relevant to the new one.

Case Study: Higher National Certificate and Diploma. In the UK the most respected foundation qualification i

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

Following aspects would a

the Higher National, comprising the Higher National Certificate HNC and the Higher National Diploma HND, both accredited by Edexcel BTEC, a prestigious validation body. I will use these qualifications to illustrate how your decision on study options is so critical. The HNC is the introd

dd to the challenges in developing combination products:

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

ctory course, providing the student with basic, but essential, knowledge of critical business functions. There are many “specialist” titles to choose from, for example “E-Business Strategy”, “Information Technology”, “Law”, and “Marketing”. However, I strongly argue that for most students

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

starting out in the world of work, the best option, by far, is the HNC Business and Management.

Whilst esoteric titles may sound attractive, they are worse than useless in terms of adding to the attractiveness of the student to employers, and in some cases will be a huge disappointment

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

ecause the content is irrelevant and out of date. The options to consider should be those that add further foundation knowledge of key business and management areas, such as “Business Decision Making”, “Business Strategy”, and “Quality Management”. The student is then armed with a strong

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

ortfolio of knowledge and understanding of the areas of activity that all managers are involved in every day. The same argument applies to the HND Higher National Diploma, which is recognised as equivalent to the first two years of a Bachelor Degree. This can be taken as a stand-alone cou

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

Professional from academic institutions, pharmaceutical industries, health care indust

se, or as a progression from the HNC. In either case, the best option is to take the HND Business (Management). Again, the options selected should be those in the mainstream areas, for example in Quality Management, Project Management, or Finance.

Although it is tempting to take a course

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

that includes what appear to be exciting and current study options, or a qualification that has a glamorous focus in the title, it is not the best choice for most people in need of a foundation business qualification. Specialist knowledge can be, should be, gained a little later, but the

.

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

irst step should be to gain a qualification that shows you understand and can contribute effectively to the essential, core, areas. This first qualification will stay with you throughout the early stages of your professional development, and be visible to all who are evaluating your poten

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

Companies that provide selfless information through particip

ial. It therefore needs to be one that demonstrates that when you decided on that course of study you were making a conscious decision to learn the essentials of business, and to give yourself the strongest possible foundation of knowledge on which to start your life in the business world

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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Advice Pool - Foundation Management Qualifications

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