Finally! An Accessible and Comprehensive Online Course on Regulatory Writing
Regulatory writers are the best-paid professionals in the Medical Writing Industry. In fact, many of them earn six-figures. Look at these data from the American Medical Writers Association 2007 Salary Survey:
Mean Income by primary Employer
Biotechnology company: $102,297
Pharmaceutical: $97,807
Medical device company: $85,451
With new drug, devices, and treatments being developed every day, pharmaceutical, biotech, medical devices companies, and Contract Research Organizations (CROs) are hiring knowledgeable writers who understand the regulatory process in the United States. You can even be a freelance regulatory writer if you wish (according to the AMWA survey, the mean gross income for the freelancers interviewed was $119,295).
As a regulatory writer you should have good knowledge of clinical study design and conduct; how to write protocols and how to read and interpret clinical data (summary tables and listings). You should also be aware of case report form design, good clinical practice (GCP) regulations and regulatory document guidelines such as the ICH.
With this online course you can learn the basics of regulatory writing without spending a fortune or leaving your house or office. The course was developed by a regulatory writer with almost 30 years of experience in the industry.
Complete this online course and receive a Certificate!
In today's competitive job market, educational credentials are vital. Add a line to your resume and show potential employers and editors that you have what it takes to be an excellent regulatory writer!
Here are some of the things you will learn in this course:
- How Medical Products are Classified: Distinction between Pharmaceutical Drugs, Biologics, Medical Devices, or Combination Products
- FDA's Regulatory Divisions
- Details Regarding Regulatory Planning, Documents Preparation, and FDA Submissions to Gain Market Approval of Drugs in the US
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A. The Drug Regulatory Process
B. Details Regarding Preclinical Research
C. Details Regarding INDs
D. Conducting Human Clinical Trials
E. The FDAs Regulation on Good Clinical Practice (GCP)
F. Submitting a New Drug Application (NDA)
G. Pre-launch Activities
H. Launch Activities
I. The Product Sales Cycle
- FDA Regulation to Gain Market Approval of Biologics in the US
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A. What are Biologics?
B. Biologics Clinical Trials Manufacturing
C. Differences and Similarities between Biologics Development and New Drug Product Development Regulations
D. Submitting a Biologics License Application for FDA Market Approval of a Biologic
- FDA Regulation to Gain Market Approval of Medical Devices in the US
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A. The Medical Device Classification
B. Premarket Notifications or 510(k)
C. Premarket Approval Applications (PMAs)
D. PMA Supplementation
E. Humanitarian Device Exemptions (HDEs)
F. Investigational Device Exemptions (IDEs)
G. IDE Amendments
H. Product Development Protocols (PDPs)
I. Medical Device Code of Federal Regulations (CFRs)
J. Steps to Obtaining Marketing Clearance from CDRH
K. Other Requirements besides Marketing Clearance
At the end of the course you will take a test to evaluate your understanding of the material and receive a certificate of completion.
What is your investment for this comprehensive course?
Many of the available workshops for regulatory writers are way too expensive—$1,850 or more for a couple of days, plus travel expenses. Even a book on regulatory writing basics would cost you about $250.
But you can take this online course from the comfort of your home for only $197. Once your interactive test is completed and your instructor gets back to you, you will receive a Certificate in the mail at no extra cost.
Free Gift for Signing Up Today
A FREE copy of the ebook Becoming a Medical Writer: How to launch a successful career writing about medicine and health . A $29 value.
Yes, Sign Me Up for this Course!
Pay by credit card or your Paypal account. You have two payment options:
1. One single payment of $197.00.
2. Or two payments of $99.00, 30 days apart.
You will gain immediate access to your gift after payment. An email with instructions on how to access the online course will arrive to your inbox within 24 hours.
Money Back Guarantee
If for any reason, you are not satisfied with the course, just contact us within 8 weeks and we'll refund 100% of your money. And you can keep your free gift!
Note: Reimbursements will not be applied after your certificate has been sent.