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I’ve been around the workforce for quite a few years - 32 years in fact. I’m currently happily employed as a Principal Consultant : Occupational Health & Safety (OHS) in a major government department and often wonder how I came to be in this senior role. One thing I can say with certainty is that when I left school, this was not on the horizon!

I do remember spending a lot of time thinking about likely car

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

eer paths, with the expectation of becoming a Clinical Psychologist and I completed a university degree with a major in Psychology. It seemed logical that there would be a neat and predictable progression along the path to becoming a Psychologist. However, life is full of twists and turns, often leading to unexpected outcomes. Kind of makes life interesting, doesn’t it?

Planning is vital. Planning without room fo

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

Examples of combination products may in

flexibility is a recipe for captivity. I planned a career in psychology and as part of that plan completed my degree. What I did not appreciate at the time was that a higher education would open several doors, not just one.

Good luck is where hard work and opportunity intersect. (Source Unknown)

Whilst undertaking my degree, and being another poverty afflicted student, I was fort

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

nate in gaining a part time job in a residential home for disadvantaged children. The work was great and seemed to complement my studies well. There was opportunity to apply learning, including behavioural techniques. After a couple of years I became a full time employee and continued my degree on a part time basis. (This did not particularly please my father, who worried that it signalled a lack of commitment to

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

y education). My employment in this position continued for nearly seven years, at which point I became aware of a full time position as Director of a child care centre, which provided care for children during the day while parents were at work. In retrospect, this was probably the first significant diversion from my initial career plan. To be honest, I thought I was an unlikely candidate, but applied anyway. Lo an

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

Combination pro

behold, I won the position on the proviso that I undertook a child care qualification. Given my completed degree and work experience, I was given credit for much of the child care course and was awarded the qualification 18 months later.

Planning pays dividends - sometimes quite unexpected!

Now working on a good salary as the senior employee of the organisation, I gained a great

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

eal of new knowledge and skills about finances, staff management, facilities management, government legislation and regulation and many other things. My work as a Director of child care centres lasted another 6 years before life threw up another unexpected opportunity. The statutory government body responsible for regulating child care employed senior staff to monitor service quality and develop new programs acros

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

a State. One of these positions in Central Office was advertised, and I applied. Again, I considered myself an “outside chance”, but I won the position. I spent 12 months developing a brand new state wide program which again brought a whole new array of learning opportunities and contacts. My name was beginning to be known across the agency and a Regional Manager invited me to join their team as a Regional Coordi

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

ator working directly with services across a wide geographic area, including country locations. Before long I won this position on a permanent basis. It was during this time I had my first “brush” with occupational health, safety and welfare, being asked to establish and lead a team of 10 trainers to train 400 staff about new OHS legislation.

I think it was about this time I decided that Clinical Psychology was n

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

longer the goal. I loved my work and didn’t want a reduction in pay to become a Psychologist! Now and again I was asked to take up more senior positions on a temporary basis to assist parts of the organisation to work through various changes, crises and conflicts. However, I retained my position as a Regional Coordinator for another 6 years at which point a major organisational restructure took place. Consequentl

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

, the Regional Manager was called in to State Office to assist with strategic planning and implementation of the new structure and I found myself elevated to an executive level position (Regional Manager) for a period of 6 months.

Change really does create new opportunity - it’s not just a clich?!

That short period of time as an executive member of an agency has been of critical i

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

Following aspects would a

portance to my subsequent mobility. It tells people that I have a strategic approach to management, understand the complexities of the socio-political environment and have demonstrated the capacity to lead and influence on a broader scale. On implementation of the new structure I spent several years in a near-country location as a District Coordinator before being called in to State Office to manage a state wide r

dd to the challenges in developing combination products:

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

source allocation process with responsibility for multi-million dollar resources. More learning. More credibility. More future flexibility.

More learning. More credibility. More future flexibility.

I briefly returned to my country district before yet another organisational restructure. As a consequence of the restructure I found myself back in State Office. This was not to my liki

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

g. However, one of my network was offered a position within another government department on a temporary basis. She was unable to accept the role, but suggested that it would be worth talking to me. I was contacted by the agency and stepped into a Project Management role relating to injury management for employees of several government departments. Familiar as I was with a great deal of legislation and regulation

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

round children’s services and education, I found myself a beginner in a new area - OHS and Injury Management. Over the last 3 years the role has evolved into more of an OHS (preventative) focus and I have learned a great deal about the social, political, financial and industrial aspects of the work. I love the fact that I have not had the chance to become stale and locked into a single career path.

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
>I know enough not to be too afraid of change.

What is my future? I don’t know and I don’t mind not knowing. I understand the future has many possible paths. My goal is to continue building knowledge and skills, work hard and seek out work to which I feel a commitment. That may be right where I am or it may involve moving to a new arena. I know enough not to be too afraid of change. Whilst others

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

Professional from academic institutions, pharmaceutical industries, health care indust

fret, I consider the possibilities. I recently applied for another position responsible for developing a state wide OHS training plan. As a newcomer, I considered myself to be an outside chance yet again, but I thoroughly enjoy working in the field. Before you leap to conclusions, let me say that I do not yet know the outcome of my application. What I do know is that I was interviewed, the interview highlighted fo

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

me the knowledge and skills that I bring, and referees have subsequently been contacted. The Recruitment Team clearly see me as a viable candidate, within the competition. In that sense I already write this up as a success.

What have I learned?

Always have a plan.

Be prepared to consider deviation from the plan.

Don’t lock yourself in to a linear career path. If it happens t

.

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

at way, fine, but keep as many doors open as possible.

Build positive relationships with people. Don’t simply focus on management and decision makers. Staff at the coal-face can exercise unanticipated influence and your reputation as a human being is important.

Look for opportunities to build new knowledge and skills, even if not directly related to your plan.

Put in the hard work.

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

Companies that provide selfless information through particip

ook at the positives resulting from change, whether change is initiated by you or others.

Say “yes” when opportunity knocks at your door.

Here I am looking at my 5th decade approaching and my career still feels fresh and exciting. I will work to keep it that way. When I retire I still want to be on the “uphill run”!

When I retire I still want to be on the “uphill run”!

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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You have the chance to deliver value to your customers at every turn - use it or deminish your brand.

The difference between leading an outrageously successful life and a mediocre one depends on your ability to set goals and create an action plan to achieve them.

Telecommuting is now more popular than it was just a few short years ago. At one time, it was a rare benefit for a select few but today has gained wider acceptance.

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