Medical Affairs
Saturday, September 24th, 2011medical affairs
 |
US $64.46
Drug Regulatory Affairs - Careers & Prospects - Pharmaceutical Industry
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
About the Author
Sumit Gupta
Global Institute of Regulatory Affairs - www.regulatoryinstitute.com
Email – info@regulatoryinstitute.com / girapune@gmail.com
|
|
Medical Product Regulatory Affairs $114.95 "This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." — Microbiology Today , May 2009 Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs. |
|
|
The Affairs of Men $6.99 Dr. Harvey Kaye, emeritus assistant clinical professor of Psychiatry at New York Medical College, has spent decades analyzing matters of gender and sexual orientation. He's seen modern men lured by the siren song of the "Masculine Mystique" and pressured to fulfill the "Dominance Drive" and the "Heroic Imperative." The result is The Affairs of Men, a wry view of the masculine wilderness. Pressured by conflicting societal and familial standards, besieged by unrelenting demands to be sexier, wealthier, more successful, "more of a man," men pay a price in marriage, in the bedroom, in the workplace, and most important, in their sense of identity. It's clear that men are at a cultural crossroads, facing difficult questions: Why do men attempt to achieve impossible goals? How do gay men fit into overall images of masculinity? Are traditional male-female relationship passé? What roles should men take in their families? The Affairs of Men wittily illuminates the world of men, looking at both the origins of western society's image of masculinity and its current landscape. Dr. Kaye states that men must embrace a new vision of what it means to be a man. Men must give up the entrenched myth of superiority that has limited them for centuries. They must learn to experience all emotions, not just societally-approved anger, hatred, and jealousy. They must learn-from each other and from the women in their lives-what it is to be fully human. |
|
|
Oklahoma Department of Veterans Affairs $79.66 High Quality Content by WIKIPEDIA articles The Oklahoma Department of Veteran Affairs (ODVA) is a department of the state of Oklahoma under the supervision of the Governor of Oklahoma charged with providing medical and rehabilitative services for veterans and their families. The Department is governed by a nine member War Veterans Commission, who members are appointed by the Governor, with the approval the Oklahoma Senate for three year terms. The Governor appoints members from names submitted by the American Legion, Disabled American Veterans, and Veterans of Foreign Wars. The Commission in turn appoints the Executive Director of the Department, who serve at the pleasure of the Commission and is responsible for administration of the Department. Author: Surhone, Lambert M./ Tennoe, Mariam T./ Henssonow, Susan F. Binding Type: Paperback Number of Pages: 120 Publication Date: 2010/08/31 Language: English Dimensions: 6.00 x 9.02 x 0.28 inches |
|
|
Medical Device Industry : Global Regulatory and Compliance Affairs $146.2 No Synopsis Available |
|
|
FDA Regulatory Affairs $216 Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval. FDA Regulatory Affairs : provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time information in a simple and concise format contains a chapter highlighting the new drug application (NDA) process discusses FDA inspection processes and enforcement options includes contributions from experts at companies such as Millennium and Genzyme, leading CRO's such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: clinical trial exemptions advisory committees provisions for fast track |
|
|
Medical Product Regulatory Affairs : Pharmaceuticals, Diagnostics, Medical Devices $112.08 No Synopsis Available |
|
|
United States Department of Veterans Affairs $70.1 High Quality Content by WIKIPEDIA articles High Quality Content by WIKIPEDIA articles The United States Department of Veterans Affairs (VA) is a governmentrun military veteran benefit system with Cabinetlevel status. It is the United States governments second largest department, after the United States Department of Defense. With a total 2009 budget of about 87.6 billion, VA employs nearly 280,000 people at hundreds of Veterans Affairs medical facilities, clinics, and benefits offices and is responsible for administering programs of veterans benefits for veterans, their families, and survivors. Author: Surhone, Lambert M./ Tennoe, Mariam T./ Henssonow, Susan F. Binding Type: Paperback Number of Pages: 102 Publication Date: 2010/08/16 Language: English Dimensions: 6.00 x 9.02 x 0.24 inches |
|
|
Internal Affairs $11.49 Internal Affairs |
|
|
Beach Affairs $15.49 Beach Affairs |
|
|
Infernal Affairs $10.49 Infernal Affairs |
|
|
Affairs Of The Heart $32.99 Affairs Of The Heart |
|
|
Foreign Affairs $5.99 Foreign Affairs |
|
|
Covert Affairs - Covert Affairs Logo $19.99 Covert Affairs - Covert Affairs Logo - T-Shirt |
|
|
Research at the Durham Veterans Affairs Medical Center (1953 - 2005) : An Overview $21.45 No Synopsis Available |
|
|
Veterans' Hospitals : List of Veterans Affairs Medical Facilities, Government House $9.45 No Synopsis Available |
|
|
Current Opinions of the Council on Ethical and Judicial Affairs of the American Medical Association, 1989 $14.63 No Synopsis Available |
|
|
FDA Regulatory Affairs : A Guide for Prescription Drugs, Medical Devices, and Biologics $210.6 No Synopsis Available |
|
|
A Woman of Affairs $12.49 A Woman of Affairs - Masterprint |
|
|
Algerian Affairs $24.99 Algerian Affairs - Photographic Print |
|
|
The Affairs $18.75 Rated: 18UPSynopsis: This discovery upsets the entire nation, and a "Tetsujin Inquiry" is set to convene. Meanwhile, the rampage of the PX Syndicate puts Japan at risk of stalling its post war recovery. The only way to stop this mayhem is to boost Tetsujin's destructive capab |
|
|
Code of Medical Ethics of the American Medical Association : Council on Ethical and Judicial Affairs, Current Opinions with Annotations, 2006-2007 $53.63 No Synopsis Available |
|
|
Affairs of Dragons $2.99 Affairs of Dragons Vinyl Sticker Do not meddle in the affairs of dragons, for you're crunchy and taste good with ketchup. |
|
|
Infernal Affairs - The Trilogy $26.99 Infernal Affairs - The Trilogy |
|
|
Internal Affairs 2 $8.49 Internal Affairs 2 |
|
|
Covert Affairs - Series 1 $23.99 Covert Affairs - Series 1 |
|
|
Covert Affairs - Series 2 $23.99 Covert Affairs - Series 2 |
|
|
Little Love Affairs $4.99 Little Love Affairs |
|
|
Southeast Asian Affairs 1990 $55.5 Southeast Asian Affairs 1990 |
|
|
Southeast Asian Affairs 1995 $52.5 Southeast Asian Affairs 1995 |
|
|
Southeast Asian Affairs 1991 $39 Southeast Asian Affairs 1991 |
|
|
Southeast Asian Affairs 1987 $34.5 Southeast Asian Affairs 1987 |
|
|
Southeast Asian Affairs 1988 $34.5 Southeast Asian Affairs 1988 |
|
|
Southeast Asian Affairs 1982 $28.2 Southeast Asian Affairs 1982 |
|
|
Southeast Asian Affairs 1985 $34.5 Southeast Asian Affairs 1985 |
|
|
Southeast Asian Affairs 1986 $34.5 Southeast Asian Affairs 1986 |