Infertility is a condition in which a couple fails to conceive after attempting unprotected sex for a period of at least one year. Statistics reveal that approximately 6 million women between the ages of 16 & 45 have infertility issues while attempting to get pregnant. Simply, infertility is the inability to conceive whether it is the female, male or both partners. More than 2 million married couples are now experiencing problems with infertility and this figure is likely to rise mainly due to our current face paced, high stressed lifestyle. Statistics also show that more than 5 million women have sought treatment from infertility specialist for help. If you are experiencing infertility it is important for you to understand that you are not alone. Although knowing this may not make you feel better, it should encourage you to know that because infertility is growing so is research and ultimately new forms of treatment.

Infertility can be broadly defined in 3 forms:

1. Primary infertility: Is defined as a woman whom has never been able to conceive.

2. Secondary infertility: Is defined as a woman whom has had a child but is unable to conceive again.

3. Repeated miscarriages: Is defined as a woman whom fails to carry the baby to term and has encountered frequent miscarriages. Although miscarriage isn?t uncommon, experiencing more than two miscarriages consecutively can be related to infertility.

It is important to understand what infertility is and also to understand the misconceptions concerning infertility. Below you will find a number of items related to misconceptions of infertility:

? Women are the only ones who suffer infertility. This isn?t true, according to medical research infertility is almost equally prevalent in men as in women. The American Society of Reproductive Medicine reveals that about 50% of the cases of infertility are related to female issues, while 30% are related to male infertility factors. The remaining percentage is attributed to problems affecting both female and male, or some unexplained factors.

? Infertility is a mental disorder affecting those people who do not want to get pregnant for some reason. Wrong! Infertility is a disorder involving the reproductive system.

? Infertility is quite common in unhealthy men and women. A person or couples health can definitely be a factor involving infertility, however it is not usually one of the key factors. There are many lifestyle factors that can be involved in creating infertility in an individual including: drinking, smoking, poor diet, exposure to chemicals, drugs and sexually transmitted diseases.

Even the healthiest of couples may experience problems in having a baby. Research shows that women are at their premium fertile state when they are between the ages of 20 & 32. After the age of 35 their fertility tends to decline rapidly. However, age is usually only one aspect of a women?s inability to get pregnant. Age is usually related to the decline in hormonal balance, which is needed to be successful with a pregnancy. Hormonal treatments may be beneficial for a woman who is attempting a pregnancy late in life.

Whatever the case may be, infertility remedies are available in may different forms from natural remedies, pharmaceuticals, surgeries and IVF. The majority of infertility cases are treatable once a proper diagnosis has been completed. The important thing is to stay positive and take charge of your own fertility plan. Whatever direction you decide to move in treating your infertility be sure to do it under a doctor?s supervision for your health as well as your unborn child. Take heart in knowing that 85% of those individuals diagnosed with some form of infertility are able to conceive. Best of luck and God Bless!

What is Regulatory Affairs???? :-

Regulatory Affairs (RA) is an upcoming profession within the biomedical / health products sector. RA profession at its heart is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world.

In an organization their prime responsibilities involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned.

They need to keep a track on ever changing legislation in all countries where the companies is looking to market their product.

RA profession is broader than registration of products, they advise companies both strategically and technically at the highest level. Their role begins right from development of a product to making, marketing and post marketing. Their advice at all stages both in terms of legal and technical requirements and restrains help companies save a lot of time and money in developing the product and marketing the same.

They have a major contribution in company’s success both Commercially and Scientifically.

Careers in Regulatory Affairs:-

Pharma is a highly regulated industry the world over and professionals, who can manage regulatory affairs, are in high demand.

Selling drugs is not like selling anything else, when we sell drugs we need to be confident that

They do what they claim to do They have been through a tough testing process to get from the lab to the market The side effects are well documented

This is where regulatory affairs come in.

“Regulatory Affairs Professional is the key link to distributing your drugs to world region.”

The Indian Pharmaceutical industry is one of the fastest growing industry in India, with a CAGR of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valued at $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally.

With such a high growth rate and rapid globalization there is a substantial need for highly trained professionals ready to perform the work required within this specialized industrial sector who will keep updates with regulatory law, policies and procedures for one or more product lines as well as maintain an understanding of the scientific and technical background of new products.

The increasing graph of the global companies’ setup in India demands the trained and skilled professional on a Handsome Salary, looking back for past few years rise in salary is multiplying.

There is a widening gap of rising demand and too few skilled human resource, this has seen a 50 % zoom on average in salaries for skilled manpower specifically in CRO sector alone.  On an average there has been over 30% rises in salaries in Pharmaceutical Sector.

Research & Development activity in the Pharma sector is seeing a rapid growth and this growth is only poised to increase the need for skilled manpower and higher pay scale to retain the skilled.

What you will need to become a RA professional :-

A good background knowledge of the pharmaceuticals and medical environment A meticulous approach to work Attention to detail. Academic Qualification in Regulatory Affairs

You can expect to work in a multidisciplinary workplace where scientists and medics will come from very different backgrounds. Excellent written and verbal communication skills are a must as is the ability to work effectively under pressure.

Global Institute of Regulatory Affairs (GIRA)

GIRA has developed a Post Graduate Diploma (Sunday batches) and Advanced P.G. Diploma in RA (Full Time) which will surely help the professionals as the program address regulatory Affairs within each category of regulatory agencies of various country, Drugs and Medical devices.

This Program will be a complement to those who carrying Science, Pharmacy and Health related degrees, there are many rewarding career opportunities with regulatory affairs for individuals with a variety of backgrounds.

The courses has been developed, under the guidance of Industry and Government Experts, to provide broad regulatory foundations, exposure to the practical, real-world applications of the regulations, and an appreciation of the important roles that regulatory affairs professionals play in the bioscience industry.

Courses are taught by experienced regulatory professionals currently working in device, diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to life and infuse their courses with relevant examples and hands-on exercises designed to prepare students for rewarding careers in regulatory affairs.

GIRA is a Division of “Perfect Pharmaceutical Consultants Pvt Ltd” – providing intelligent regulatory solutions since last 20 years

Please contact GIRA for  “FREE Counseling & Course Prospectus”

To know more on RA and its Career visit White Paper section on

Global Institute of Regulatory Affairs

www.regulatoryinstitute.com

Recent years have seen CI groups on the upswing. Their role is evolving and developing a greater emphasis on adding strategic value. At the same time, CI’s budgets and staffing are increasing. Recent trends in structuring have led to increased efficiency. These are certainly encouraging signs, and CI groups are adapting to the changes.But there is still much work to be done. CI teams still must fight for resources to succeed. They must also demonstrate their value and trumpet their successes. To not only survive, but to thrive as a function, CI must attract top talent, increase its reach and create a CI culture within an organization.Pharmaceutical Competitive Intelligence examines top companies’ practices to provide a guide for improving CI efforts. This report presents the focal points of the research in three chapters:

* Structuring for Success – Provides details on CI structures, including global-level reporting lines and placements; ways in which CI team trumpet their successes and create CI cultures; and the career paths laid out to make CI teams breeding grounds for future pharma leaders
* Resourcing for Growth – Reveals CI department-level budgets and staffing; brand-level phase-by-phase spending and staffing, which groups fund CI; and how companies demonstrate ROI on CI
* Increasing CI’s Reach – Examines how companies communicate their strategic value to internal clients and the resources and tools for collecting CI
 

To know more and to buy a copy of your report feel free to visit : http://www.bharatbook.com/detail.asp?id=77309&rt=Pharmaceutical-Competitive-Intelligence-Expanding-the-Role-and-Reach-of-CI-PH110.html

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What is Regulatory Affairs???? :-

Regulatory Affairs (RA) is an upcoming profession within the biomedical / health products sector. RA profession at its heart is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world.

In an organization their prime responsibilities involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned.

They need to keep a track on ever changing legislation in all countries where the companies is looking to market their product.

RA profession is broader than registration of products, they advise companies both strategically and technically at the highest level. Their role begins right from development of a product to making, marketing and post marketing. Their advice at all stages both in terms of legal and technical requirements and restrains help companies save a lot of time and money in developing the product and marketing the same.

They have a major contribution in company’s success both Commercially and Scientifically.

Careers in Regulatory Affairs:-

Pharma is a highly regulated industry the world over and professionals, who can manage regulatory affairs, are in high demand.

Selling drugs is not like selling anything else, when we sell drugs we need to be confident that

They do what they claim to do They have been through a tough testing process to get from the lab to the market The side effects are well documented

This is where regulatory affairs come in.

“Regulatory Affairs Professional is the key link to distributing your drugs to world region.”

The Indian Pharmaceutical industry is one of the fastest growing industry in India, with a CAGR of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valued at $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally.

With such a high growth rate and rapid globalization there is a substantial need for highly trained professionals ready to perform the work required within this specialized industrial sector who will keep updates with regulatory law, policies and procedures for one or more product lines as well as maintain an understanding of the scientific and technical background of new products.

The increasing graph of the global companies’ setup in India demands the trained and skilled professional on a Handsome Salary, looking back for past few years rise in salary is multiplying.

There is a widening gap of rising demand and too few skilled human resource, this has seen a 50 % zoom on average in salaries for skilled manpower specifically in CRO sector alone.  On an average there has been over 30% rises in salaries in Pharmaceutical Sector.

Research & Development activity in the Pharma sector is seeing a rapid growth and this growth is only poised to increase the need for skilled manpower and higher pay scale to retain the skilled.

What you will need to become a RA professional :-

A good background knowledge of the pharmaceuticals and medical environment A meticulous approach to work Attention to detail. Academic Qualification in Regulatory Affairs

You can expect to work in a multidisciplinary workplace where scientists and medics will come from very different backgrounds. Excellent written and verbal communication skills are a must as is the ability to work effectively under pressure.

Global Institute of Regulatory Affairs (GIRA)

GIRA has developed a Post Graduate Diploma (Sunday batches) and Advanced P.G. Diploma in RA (Full Time) which will surely help the professionals as the program address regulatory Affairs within each category of regulatory agencies of various country, Drugs and Medical devices.

This Program will be a complement to those who carrying Science, Pharmacy and Health related degrees, there are many rewarding career opportunities with regulatory affairs for individuals with a variety of backgrounds.

The courses has been developed, under the guidance of Industry and Government Experts, to provide broad regulatory foundations, exposure to the practical, real-world applications of the regulations, and an appreciation of the important roles that regulatory affairs professionals play in the bioscience industry.

Courses are taught by experienced regulatory professionals currently working in device, diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to life and infuse their courses with relevant examples and hands-on exercises designed to prepare students for rewarding careers in regulatory affairs.

GIRA is a Division of “Perfect Pharmaceutical Consultants Pvt Ltd” – providing intelligent regulatory solutions since last 20 years

Please contact GIRA for  “FREE Counseling & Course Prospectus”

To know more on RA and its Career visit White Paper section on

Global Institute of Regulatory Affairs

www.regulatoryinstitute.com

What is Regulatory Affairs???? :-

Regulatory Affairs (RA) is an upcoming profession within the biomedical / health products sector. RA profession at its heart is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world.

In an organization their prime responsibilities involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned.

They need to keep a track on ever changing legislation in all countries where the companies is looking to market their product.

RA profession is broader than registration of products, they advise companies both strategically and technically at the highest level. Their role begins right from development of a product to making, marketing and post marketing. Their advice at all stages both in terms of legal and technical requirements and restrains help companies save a lot of time and money in developing the product and marketing the same.

They have a major contribution in company’s success both Commercially and Scientifically.

Careers in Regulatory Affairs:-

Pharma is a highly regulated industry the world over and professionals, who can manage regulatory affairs, are in high demand.

Selling drugs is not like selling anything else, when we sell drugs we need to be confident that

They do what they claim to do They have been through a tough testing process to get from the lab to the market The side effects are well documented

This is where regulatory affairs come in.

“Regulatory Affairs Professional is the key link to distributing your drugs to world region.”

The Indian Pharmaceutical industry is one of the fastest growing industry in India, with a CAGR of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valued at $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally.

With such a high growth rate and rapid globalization there is a substantial need for highly trained professionals ready to perform the work required within this specialized industrial sector who will keep updates with regulatory law, policies and procedures for one or more product lines as well as maintain an understanding of the scientific and technical background of new products.

The increasing graph of the global companies’ setup in India demands the trained and skilled professional on a Handsome Salary, looking back for past few years rise in salary is multiplying.

There is a widening gap of rising demand and too few skilled human resource, this has seen a 50 % zoom on average in salaries for skilled manpower specifically in CRO sector alone.  On an average there has been over 30% rises in salaries in Pharmaceutical Sector.

Research & Development activity in the Pharma sector is seeing a rapid growth and this growth is only poised to increase the need for skilled manpower and higher pay scale to retain the skilled.

What you will need to become a RA professional :-

A good background knowledge of the pharmaceuticals and medical environment A meticulous approach to work Attention to detail. Academic Qualification in Regulatory Affairs

You can expect to work in a multidisciplinary workplace where scientists and medics will come from very different backgrounds. Excellent written and verbal communication skills are a must as is the ability to work effectively under pressure.

Global Institute of Regulatory Affairs (GIRA)

GIRA has developed a Post Graduate Diploma (Sunday batches) and Advanced P.G. Diploma in RA (Full Time) which will surely help the professionals as the program address regulatory Affairs within each category of regulatory agencies of various country, Drugs and Medical devices.

This Program will be a complement to those who carrying Science, Pharmacy and Health related degrees, there are many rewarding career opportunities with regulatory affairs for individuals with a variety of backgrounds.

The courses has been developed, under the guidance of Industry and Government Experts, to provide broad regulatory foundations, exposure to the practical, real-world applications of the regulations, and an appreciation of the important roles that regulatory affairs professionals play in the bioscience industry.

Courses are taught by experienced regulatory professionals currently working in device, diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to life and infuse their courses with relevant examples and hands-on exercises designed to prepare students for rewarding careers in regulatory affairs.

GIRA is a Division of “Perfect Pharmaceutical Consultants Pvt Ltd” – providing intelligent regulatory solutions since last 20 years

Please contact GIRA for  “FREE Counseling & Course Prospectus”

To know more on RA and its Career visit White Paper section on

Global Institute of Regulatory Affairs

www.regulatoryinstitute.com

Tangible assets such as machinery and equipment produce income over several years. These tangible assets usually have easily ascertainable costs, which are spread over the assets’ estimated useful lives in the form of depreciation expense. On the other hand, one month’s rent payment is an expense because the outlay entitles the firm to only one month of economic benefit. Now consider the following example of an R & D cost.

Example. Mizer Pharmaceutical has in the last five years spent $65 million on research and testing of a male enhancement pill that actually works and can garner FDA approval. The five years of research and development outlays has lead to the development of an effective pill that they will market and patent under the trade name Mirakle Grow. Market research indicates that it will generate at least $1 billion in sales annually as long as they hold the exclusive patent.

Since the R & D outlays have lead to the development of a pill that will generate significant revenue over several years you would expect that the outlays would be classified as assets rather than period expenses. Well you would be wrong. In fact, accounting rules require that R & D costs be treated as expenses rather than assets even though these outlays clearly are intended to benefit future accounting periods. There are two reasons why accounting rules treat R & D outlays as expenses.

First it is a cruel fact of life that not all R & D outlays lead to the development of marketable products. In fact, a relatively low percentage of such outlays lead to successful products. For example, it may turn out that the Mirakle Grow drug has adverse side effects that would preclude FDA approval.

A second problem in treating R & D costs as assets involves deciding their useful life. Assuming that successful R & D costs can be identified, over what period of time do we spread or amortize these costs? If the R & D costs lead to a patent we could simply use the life of a patent as our guide. But what really matters is the life cycle of a successful new product, not the period of patent enforceability. Who knows how long a period that should be? In the case of Mizer’s male enhancement pill it is entirely possible that an alternative pill developed by a competitor could provide stiff competition to Mirakle Grow. If this occurs demand for Mirakle Grow might peter out in a much shorter period of time than the life of the patent.

If accounting rules allowed the treatment of R & D costs as assets, management would be sorely tempted to record both unsuccessful and successful outlays as assets. This would lead to the overstatement of assets, the understatement of expenses and in turn the overstatement of income. Even if management were neutral and fair minded it is often impossible to predict which R & D costs will lead to successful products and which will not.

Unintended Consequences

Accounting rule maker’s decision to not treat R & D costs as assets probably has undesirable consequences for firms and society as a whole. In the current environment in which publicly traded firms are managed there is great pressure on managers to insure that stock prices are maintained. CEO’s of large corporations are partially compensated and evaluated based upon their firm’s stock price. In turn, stock prices are greatly affected by the current and near term reported earnings of the company. Under current accounting rules a CEO interested in short-term earnings will avoid long term R & D commitments because they will depress current earnings and hence the stock price. However the long-term prospects of a business may be enhanced significantly by increased expenditures on R & D. So the accounting treatment of R & D probably serves as a disincentive to make such outlays despite the fact that such outlays might be in the long run best interest of the firm.

Society is probably also better off if companies increase their R & D outlays. So the current R & D rules may be bad for businesses and bad for society as a whole. The rules may prevent individual firms from overstating income and assets in the short run but reduce the income of the firms and the well being of society in the long run.

What is Regulatory Affairs???? :-

Regulatory Affairs (RA) is an upcoming profession within the biomedical / health products sector. RA profession at its heart is all about Collecting, Analyzing and Communicating the Risks and Benefits of health care products to regulatory agencies and public all over the world.

In an organization their prime responsibilities involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned.

They need to keep a track on ever changing legislation in all countries where the companies is looking to market their product.

RA profession is broader than registration of products, they advise companies both strategically and technically at the highest level. Their role begins right from development of a product to making, marketing and post marketing. Their advice at all stages both in terms of legal and technical requirements and restrains help companies save a lot of time and money in developing the product and marketing the same.

They have a major contribution in company’s success both Commercially and Scientifically.

Careers in Regulatory Affairs:-

Pharma is a highly regulated industry the world over and professionals, who can manage regulatory affairs, are in high demand.

Selling drugs is not like selling anything else, when we sell drugs we need to be confident that

They do what they claim to do They have been through a tough testing process to get from the lab to the market The side effects are well documented

This is where regulatory affairs come in.

“Regulatory Affairs Professional is the key link to distributing your drugs to world region.”

The Indian Pharmaceutical industry is one of the fastest growing industry in India, with a CAGR of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years. It is valued at $ 8.0 billion approximately and ranks 4th in terms of volume and 13th in terms of value globally.

With such a high growth rate and rapid globalization there is a substantial need for highly trained professionals ready to perform the work required within this specialized industrial sector who will keep updates with regulatory law, policies and procedures for one or more product lines as well as maintain an understanding of the scientific and technical background of new products.

The increasing graph of the global companies’ setup in India demands the trained and skilled professional on a Handsome Salary, looking back for past few years rise in salary is multiplying.

There is a widening gap of rising demand and too few skilled human resource, this has seen a 50 % zoom on average in salaries for skilled manpower specifically in CRO sector alone.  On an average there has been over 30% rises in salaries in Pharmaceutical Sector.

Research & Development activity in the Pharma sector is seeing a rapid growth and this growth is only poised to increase the need for skilled manpower and higher pay scale to retain the skilled.

What you will need to become a RA professional :-

A good background knowledge of the pharmaceuticals and medical environment A meticulous approach to work Attention to detail. Academic Qualification in Regulatory Affairs

You can expect to work in a multidisciplinary workplace where scientists and medics will come from very different backgrounds. Excellent written and verbal communication skills are a must as is the ability to work effectively under pressure.

Global Institute of Regulatory Affairs (GIRA)

GIRA has developed a Post Graduate Diploma (Sunday batches) and Advanced P.G. Diploma in RA (Full Time) which will surely help the professionals as the program address regulatory Affairs within each category of regulatory agencies of various country, Drugs and Medical devices.

This Program will be a complement to those who carrying Science, Pharmacy and Health related degrees, there are many rewarding career opportunities with regulatory affairs for individuals with a variety of backgrounds.

The courses has been developed, under the guidance of Industry and Government Experts, to provide broad regulatory foundations, exposure to the practical, real-world applications of the regulations, and an appreciation of the important roles that regulatory affairs professionals play in the bioscience industry.

Courses are taught by experienced regulatory professionals currently working in device, diagnostic, pharmaceutical and biologic sectors. Instructors bring the regulations to life and infuse their courses with relevant examples and hands-on exercises designed to prepare students for rewarding careers in regulatory affairs.

GIRA is a Division of “Perfect Pharmaceutical Consultants Pvt Ltd” – providing intelligent regulatory solutions since last 20 years

Please contact GIRA for  “FREE Counseling & Course Prospectus”

To know more on RA and its Career visit White Paper section on

Global Institute of Regulatory Affairs

www.regulatoryinstitute.com