Advice Pool - Reference and Education

So, what needs to be done to ensure that a distance learning course is a success, in a nutshell, treat it like a project. Take it seriously and manage it professionally. Make sure it is an appropriate project to take on, one that it fits in with your objectives, your career or personal development plans, your strategy. Prepare for it, plan it, consider other “stakeholders”, monitor progress, respond to changing circumstances, make adjustments as necessary, and when it’s endin

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

g, close it down properly.

Before you take on a course of study, by distance learning, you should make sure that the course and qualification that you choose fits in with your personal development plan, your career development plan, your objectives. To make sure this is the case, you need a plan.

If you have not drawn up a development plan, then you must do this, taking advice where needed, before you commit to any new development activity. The questions that you must ask i

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

Examples of combination products may in

: “Does this fit in with my plans?” - “Will this help me to achieve my goals, my objectives?” – “Will this be of use to me at the time I finish it?”. One important issue to address is that your personal development plans and objectives take you into the future, and your course will also not be completed until a year or two into that future. What is a valuable qualification today may not be so valuable in two or three years time. Research the business sector that you are in,

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

or are planning to move into. Look for trends and recent changes that indicate what will be needed in 3 to 5 years time. Look at the recent developments in diversity, in understanding other cultures, the growing appreciation of quality management, and project management. These are good examples of trends that can confirm that the knowledge gained and qualification achieved, from a one or two year course of study will be still be relevant in the future.

Another issue is the r

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

levance of the qualification, in terms of your age, your status, what is required for progression in your sector, your profession. What is without doubt a valuable qualification for a 21 year old, for example, a first degree, is probably not going to be attractive to employers if the newly qualified holder is 29 or 39. Think about it, 99% of first degree holders have that qualification at 21 or 22, what does that say about a 29 or 39 year old, when at 29 or 39 the qualificati

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

Combination pro

n that is expected of you is a postgraduate, professional, one. A qualification in Marketing may be appealing to you personally, but may be seen as illogical and irrelevant by employers or clients in your business sector. Some qualifications, or skills, however, do have relevance across the board. An example is a foreign language, a high value addition in any sector. Another is knowledge of finance, not a professional accountancy qualification, but one that shows you have a

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

broad understanding of the discipline. If you are not sure about the course or qualification being relevant to your future, ask for advice. Any reputable provider will help and will not try to persuade you to take an inappropriate course.

In this project, the project team is made up of you the student, the provider and their back up team and resources, the tutor that will work with you, and some important stakeholders.

If you are the student, appoint yourself as the project

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

manager. If you are an employer, appoint yourself as the client and behave like a major stakeholder in this project.

It is important that you research potential providers – potential team members. Look at the range of courses they offer. If it is massive, everything from dog handling to nuclear physics – back away!!. If it is focused, with a core area of expertise, investigate that provider further, they are more likely to be serious and knowledgeable in that area of experti

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

e.

Check out the potential providers’ accreditations. In the UK and most developed countries, there are government appointed, or approved, accreditation bodies (sometimes known as validation bodies). If the provider is nationally accredited, in their field of expertise, by that county’s recognised accreditation bodies, that is a very positive sign.

Once you have selected your provider and course – prepare. This means thinking about what your planned course of study will me

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

n – to your lifestyle, your time, your social life, your domestic situation, your workload. With all these in mind, start preparing for your course of study by thinking!. Think about the implications, think about what resources you will need. This includes computer equipment, almost certainly broadband access, and a physical study area. Although most of these can be found outside the home, most distance learning students do study at home. Think about what changes you will ha

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

e to make, some small, some major, to successfully complete the course. This can include changes to your lifestyle, your social life, your domestic life, your work patterns, your hobbies and interests, there may, not always but often, need to be changes in some or all of these areas. Think about all the people who will be affected by your decision to take up a course of studies, see Stakeholders, below.

Stakeholders, these, as in project management terms, are any people who

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

Following aspects would a

have a “legitimate interest” in the project. In the case of a student taking a distance learning course, this means, amongst others, your partner, family, social friends, work colleagues, managers, your employer, these all have a “legitimate interest” in your decision and your study “project”, this means they are stakeholders in your project. Treat them in the same way that professional project managers treat their stakeholders. Think about their needs, think about their con

dd to the challenges in developing combination products:

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

erns, keep them informed appropriately, of your progress, treat them as partners in your project. For special stakeholders, such as your partner, your family, talk to them. Involve them, explain what you are going to be doing, talk about the fact that you will need some time to yourself, to study, explain that you are not abandoning them, you are starting some important, essential, personal development that needs careful organisation, and some understanding from them. But, ma

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

e sure that you plan some “rewards” into this. If you are going to be studying in isolation for a couple of evenings or half a day on the weekend, then give something in return. For example, plan into your schedule a day off, a day out, some time with your partner, your family, or your friends. Find a way to say “thank you for supporting me”.

Planning: plan how, and when, and what with, you will study. Draw up a timetable, if this is not already laid down by the demands of th

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

course of its assignment or examination deadlines. Break it down into manageable periods. The course requirements, units, modules, assignments, examinations, will usually give you this structure. Plan when you will study, where you will study, how you will study. Plan time for reading, going on the internet, visiting the library, writing up assignments, traveling to sit examinations, all these need careful planning. Your course Tutor will often be able to help with this. She

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

he will have experience of assisting new students in planning their studies.

Monitoring: monitor your progress on a regular, usually weekly, no less than monthly, basis. Use your tutor, she/he will be happy to give you deadlines, objectives, advice and guidance, that will help you manage the course and stay on target.

Respond to changing circumstances. One of the most attractive features of studying by distance learning is that it is a flexible, adaptable, method of studyin

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

Professional from academic institutions, pharmaceutical industries, health care indust

g. All human beings, run into personal problems, illnesses, difficulties at work, family crises, become temporarily disenchanted, temporarily lose interest in the course. If you are hit by any of these, and you will be a rare student if you are not hit by at least one of these, talk to your tutor, talk to your “client” (your employer) if you have one, as soon as you run into any difficulties. Such problems are “normal” for distance learning students. The bonus is that as a

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

istance learning student, on most courses, you can manage these difficulties by slowing down, stopping, starting up again, speeding up, as often as it takes, because you are on a distance learning course. For classroom students, such problems usually mean disaster, classes continue, but if you miss them, you are immediately at a disadvantage.

At the end of a project, professional project managers make sure that they carry out a “close down” routine. For the distance learning

.

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

student, this is what you must do. Make sure that you have successfully completed all the assignments, passed all the examinations, if any, and studied the course materials fully. Inform all the stakeholders that you have successfully completed the course, and achieved the qualification. Receive confirmation of completion, a certificate of achievement, a letter confirming your examination successes, for example. Thank all the people who have helped you succeed, your partner

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

Companies that provide selfless information through particip

family, friends, work colleagues, tutor, provider organisation.

In today’s world you need to continually, constantly, appropriately, develop your professional skills and update your professional qualifications. Your competitors, those individuals or those businesses, with active, live, dynamic development plans, are moving forward, taking on new challenges, refining their plans, achieving more successes. You need to keep up with them or better keep ahead of the competition

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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