Is Distance Learning For You ?

There are numerous distance learning benefits which you ought to consider when electing to take a distance learning course.

• Distance education promotes the opportunity to meet the needs of students unable to attend on-campus classes.
• One of the biggest distance learning benefit is the issue of flexibility and time. A student is not confined to classroom for a certain number of hours on a given day.
• Increased access to learning
• Promotes life long learning
• Better marketability
• Increased compensation and promotion potential
• Another benefit of distance learning to students is the ability to do interactive teamwork between groups. Students have the opportunity to correspond with others from different backgrounds and to hear from a variety of speakers from around the world.
• The use of Distance Learning can allow you to send your homework assignment at any time of day - safe and convienent. What a benefit for distance learning!
• You can securely join this Distance Learning Program exam without the need for attending a traditional classroom miles away.
• Financial benefits of distance learning exist as well. Without the need to leave your home for spending a semester or a year in a distant city, you can substantially save on transportation, housing, and food costs. It goes without saying that you can keep your full or part time job at the same time you matriculate to a distance learning institution.
• Social benefits of distance learning? Without having to leave your community, you maintain your personal, cultural, and social lifestyle. Your circle of comfort is maintained, reducing additional stress.
• Live anywhere, study from anywhere while pursuing the education of your choice. You don't have to live in the same city or the same country to attend the learning institution of your choice. You can study wherever you have access to a computer and Internet connection
  
  
  

STUDENTS WORKING ON MATLAB 7.0..............DEVELOP YOUR (IT) SKILL

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Changes In Indian Regulatory Affairs

Go CDA ! Get Global !!
Big Wait!! - But better late than never. The crux of centralizing drug authority to meet the global standards seems to get resolved in the months to come. A major issue that was resurfaced time and again since independence in Pharmaceutical Industry since its evolution is ready to gain the benefits in the global market.
CDA or Central Drug Authority, in real terms will be a major breakthrough for pharmaceutical industry in India, as it will open Global opportunities for India. Under CDA , a chairman will be appointed with three to five members with comprehensive powers at national level to control and regulate the pharmaceutical affairs as per the drugs and Cosmetics(amendment) Bill 2007. The bill to be brought up in upcoming winter session of parliament will empower and strengthen the Drug regulatory Authority by centralizing the licensing authority in the hands of chairman in parallel with global standards.
With the proposed Structure of Drug Regulatory Authority, a plethora of Global opportunities will prop up. These opportunities will cover, contractual manufacture (agreement for global manufacture of pharmaceutical products in compliance to the international standards), contractual research and development including formulation development, clinical research, collaborative clinical trials and customized synthesis, services like analytical method development and validation, clinical data management, ancillary equipment and material production, and manufacture of packaging material. India is a hub for contractual manufacturing process of pharmaceutical products due to its cheapest manufacturing cost across the globe. Thus, the licensing being centralized, Vaccine manufacturing units in India will gain the most. Only 15 countries around the globe producing vaccines hold Licensing of Vaccines on Global Standards. India will get the cutting edge over others once CDA get formulated as India holds 14 units who manufactures vaccines. While figure for other countries producing vaccines merely reaches to a high of maximum 5 units.
The CDA will now have a chairman with not more than five members but at least three members , to be appointed by Central govt. with the defined criteria for the qualification and procedure of appointment. The CDA office will be maintained at Delhi and all the existing power of CDSCO to be shifted to CDA itself. DCGI (Drug Controller General India) will then work under Chairman with additional DC(I) appointed separately both in AYUSH and Drugs. Under this will come ten departments to be controlled by DCGI and they will include Regulatory affairs, Imports, New drugs, Biotechnological Products, Pharmacovigilance, Medical Devices and Diagnostics, Organizational Services, Training, Quality Control affairs and legal and Consumer affairs.

Source:http://fermish.com

Bright Future For Regulatory Professionals:Career In Regulatory Affairs

Must Read:The Regulatory Affair Profession In India

Training Needs In Regulatory Science For The Biopharmaceutical Industry

For regulatory affairs professionals as well as newly hired scientists, a solid grasp of regulatory science is needed to succeed in pharmaceutical R&D.

The pharmaceutical, biotechnology, and medical device research and development industries are among the most highly regulated in the country. While small companies engaged in early research and development usually do not have an individual designated to handle regulatory affairs, every pharmaceutical research and development company worth its salt has an individual or department devoted to regulatory affairs. The regulatory affairs professional is the primary communication link between the company and worldwide regulatory agencies such as the US Food and Drug Administration (FDA; Rockville, MD). In addition, he or she serves as the primary communicator of the seemingly endless list of laws, regulations, guidelines, and guidances from these regulatory agencies, and as the interpreter of these documents to the other members of the company's research, development, manufacturing, and compliance staff. As a consequence of successfully fulfilling his or her responsibilities, the regulatory affairs professional interacts with the vast majority of the other departments within the company.The regulatory affairs professional not only must read and understand each regulation, but must have an appreciation of its place in the regulatory "milieu". This requires that he or she have a thorough understanding of the history of the FDA and of a particular regulatory document, as well as an appreciation for the evolution of the regulatory process on a worldwide basis. It is imperative to have an understanding of not only the words contained in a regulatory document, but the intended result envisioned by the individuals who drafted this regulatory document. Also, in order to adequately interpret this regulatory document to colleagues, the regulatory professional must have a clear understanding of the organization, procedures, and resources of his or her own company. Over the years, a number of organizations, such as the Regulatory Affairs Professional Society (RAPS), the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and international organizations like the European Society of Regulatory Affairs, have taken an increasing role in providing educational meetings for the regulatory affairs professional.As an alternative, one can attend a growing number of meetings presented by commercial training companies, such as Parexel-Barnett and the Pharmaceutical Education and Research Institute (PERI).

Source:Nature Biotechnology

Source:Hindustan Times,June 16,2008

Generics Drugs & FDA

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Drug Licensing Audit in India - Hail the Author

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Wonderful Regulatory Presentation - Hail The Author

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Source: Times Ascent June 11,2008

Source: Hindustan Times ,June 13, 2008

Professional Development in Regulatory Affairs

This article explores the many ways in which regulatory affairs (RA) professionals achieve growth and developmental in their careers. It also explores ways to encourage non-regulatory professionals interested in RA to develop their skills to fit into the RA profession. The article also attempts to explain the day-by-day functions, responsibilities and decisions of regulatory professionals and their effect on compliance issues in drug/biologic/device product development,approval and marketing.In order to establish and maintain a focused career in regulatory affairs, there is a continuous need to develop through training, learning and participating in the regulatory developmental process, in addition to interacting with others in the profession. One should always seek all available opportunities to expand one’s RA knowledge by attending internal company scientific presentations and external research and development seminars, participating in regulatory compliance workshops and taking regulatory training classes as often as possible. To achieve competency in RA, one should be prepared to answer the following questions:
• What skill sets are needed to perform the various regulatory functions?
• When does one go about implementing a plan to learn such skills?
• Where does one obtain such skills?
• How does one establish, maintain and improve these skill sets?
• What are the desired skills?
Having been exposed to different departments at various companies, RA departments should always strive to attract talented individuals with a good fit to the company and then provide a high level of experience that will increase their know-how. Regulatory departments should work diligently to retain their associates and provide incentives to prevent trained, experienced and talented individuals from leaving. Relevant experience, a good fit with the position and an effective department, as well as a company culture that is committed to excel, are all necessary ingredients in the success of an RA professional and the industry as a whole.

SOURCE:Regulatory Affairs Professional Society

IS IT TIME FOR ACADEMIC PREPARATION OF FUTURE REGULATORY AFFAIRS PROFESSIONAL ?

The regulation of medical products has been expanding since early
in the 20th century. Regulatory agencies are being established in
an ever-increasing number of countries across the globe. Those
that have established regulatory agencies are revamping their
systems and attempting to harmonise with other selected
jurisdictions. Agencies are also requiring more compliance activities
and increasingly complex activities from the regulated industries
that market products within their jurisdictions. This mushrooming
regulatory framework and the associated increased regulatory burden
have placed significant strains on the existing pool of experienced
regulatory affairs professionals worldwide. In fact, there are those
in the industry that have expressed this current shortage of
regulatory affairs professionals as ‘massive’1. This conclusion is further
supported by a 1999 study2 that suggested that the demand would
continue to increase. All one needs do to personally validate these
beliefs is to talk to the many employers who are struggling to find
experienced regulatory affairs professionals and also to the regulatory
affairs professionals who are barraged with regular telephone
enquiries from placement agencies with numerous and lucrative new
positions. As the regulatory affairs profession is practised in a variety
of environments, it is logical to assume that this shortage of qualified
personnel is shared not only by the regulated industry but also by
regulatory agencies across the globe.

SOUCE: Medical Device Consultants Inc.

BII Clinical Trial Weekend Program - Join Now

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Regulatory Affairs Professional: In a New Era

So, what has changed? In short, business. Historically, most regulatory professionals started their professional lives in the R&D laboratories, until beginning their 'retirement' in Regulatory. These days, there are many more healthcare professionals in Regulatory who have intentionally chosen the field as a career, and frequently switch between industry and the regulatory authorities. The best advice companies can obtain is from a combination of ex-regulators combined with that of industry development experts with a business focus. The attitude now is not "We can't do that," but rather "How can we get it done? Within given time and money constraints, how do we get the product onto the market? What is the best route? Which market or markets first?" The best regulatory people work hand-in-hand with marketing and R&D to develop innovative, risk-taking development plans that take advantage of new technological and regulatory developments to accelerate time to market. With new products expected to have significant revenues from Day One, small decreases in time to market equate to material gains in revenue and profit. Employing adaptive clinical trial strategies, obtaining early buy-in from the major regulatory authorities, and avoiding pitfalls in processes can accelerate development and help to prevent costly errors. In the days before email, the regulatory function was usually combined with a quality assurance (QA) or compliance role (and this is still frequently the case in the medical device industry). This fitted in very well with the perceived role of Regulatory as the 'company police,' ensuring compliance with all relevant legislation, regulations and guidelines. Today, these two roles are separated. Regulatory affairs should be the driver of development, accelerating rather than putting a brake on projects. Compliance and QA are, of course, critical functions, but should be entirely separate.

Source: Strategic RA Consulting

DEAR ADMIN
WHEN WE CAN EXPECT THE RESULTS OF RECENTLY HELD EXAMS?
DR.R.SRINIVASA RAO
INDUSTRAIL PROGRAMME IN PHARMA REG AFFAIRS

Regulatory Professionals: The Hub Of The Wheel

Pharmaceutical companies' regulatory affairs units are more vital than ever, but, traditionally, they have not been known for their flexibility. Peter Lassoff explains why this image is outdated, and how working more co-operatively with your regulatory department will help to maximize your success in the market place. Experienced regulatory professionals are a very valuable resource for development in a variety of ways. Recently we have seen some dramatic failures to obtain regulatory approval in large blue-chip companies; the quest to find the new aspirin or warfarin is as difficult as ever, and even the largest companies are now reconsidering regulatory strategy as a result.Back in those prehistoric times, Regulatory (or 'Registration', as it was then) was more or less a 'post office,' and the work essentially involved compiling reports written by the experts in R&D and mailing them to the various regulatory authorities.The modern view of regulatory affairs is as a dynamic, business-oriented unit, focused on getting products to the market with a commercially viable label, as quickly as possible and for the least possible expense. Regulatory is involved at a very early stage in the development process, often helping with 'portfolio management,' choosing which products should progress to the clinic.

Source: Strategic RA Consulting

Job Openings

Source: Times Ascent June 04, 2008

The State of Affairs: An Overview of the Regulatory Affairs Profession

Source:http://sciencecareers.sciencemag.org/

Regulatory affairs (RA) within the biomedical/health products sector is a relatively young, multidimensional profession that is international in scope. At its core, the RA profession facilitates the collection, analysis, and communication about the risks and benefits of health products to regulatory agencies, medical care systems, and the public. Operationally, RA is responsible for assuring that government obligations, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders of the medical and health care system.
RA professionals come from a variety of disciplines such as law, academic and industrial research, and medicine. RA is a promising field for scientists searching for alternative careers because it offers a multitude of starting jobs and opportunities for advancement.

Regulatory affairs professionals are employed in industry, government, and in academic research and clinical institutions. The full scope of regulatory affairs varies somewhat among organizations. However, regulatory affairs professionals play a pivotal role in facilitating the progression of new health products and technology through the product life cycle (see figure).

International Seminar on "Global Clinical Trial Management & Logistics"

16th International Seminar on "Global Clinical Trial Management & Logistics" is about to held on 6th June 2008.
Venue: Renaissance Hotel, Mumbai
Topics to be covered:
Ethics & GCP: Clinical Research
Partnerships with CRO's
Clinical Trial Trends in India
Clod Chain Management
The Patent Regime & the Present status of R&D in India
Investigtaor Challenges & site Monitoring Techniques
Clinical Trials in Emerging Markets
Changes in IATA Regulations
CTM Storage & Distribution in Emerging counties
Bioequivalence Studies - Outsourcing Models

For further information contact:
World Courier India Pvt.Ltd
3rd Floor, Freight Wings House
Makwana Road, Marol
Andheri East
Mumbai 400059
India
Phone: 022 - 67102861
Email: mumbaiseminar@worldcourier.co.in
Web: www.worldcourier.com/seminar