MWT Courses
MedicalWritingTraining.com
Clinical Trial Reporting
and Regulatory Writing for Medical Writers
Complete Guide to Clinical & Regulatory Writing for Research Professionals & Medical Writers
Are you a clinical research professional who is charged with writing a clinical study protocol?
Or a medical writer looking for guidelines to use for writing an IND for a new drug? If so, this course is for you.
Clinical trials have very stringent guidelines that must be followed. The same is true regarding the documentation required by the Food and Drug Administration. If these guidelines are not followed, then the entire regulatory approval may be delayed or jeopardized altogether.
Medical writers and clinical research professionals must understand the regulatory requirements for all regulatory reports that they are required to write during their careers.
This course distills the regulations regarding the most common regulatory documents into a single, user-friendly guide.
Developed by a regulatory writer with more than 20 years of experience in the field, this course will show you how to develop each of these documents:
• Pre Investigational New Drug (IND) Application
• Investigational New Drug (IND) Application
• Investigational New Drug (IND) Reports
• Informed Consent Form
• Investigator’s Brochure
• Clinical Reports
• Pre New Drug Application (Pre-NDA)
• New Drug Application (NDA)
• Patient Narratives
• Manuscripts
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!
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.
(See here, for example.)
Even a book on regulatory writing basics would cost you more than $230.(Like this book)
But you can take this online course from the comfort of your home for only$247. 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 $247.00.
2. Or two payments of $125.00, 30 days apart.
You will gain immediate access to the course after payment.
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.
Tax Deductible - Keep your receipt. In the USA, all expenses of continuing education undertaken to maintain and improve business and professional skills are tax deductible. (Treas. Reg. 1-162-5). Please contact your tax consultant for further information.
What Regulatory Writers are Saying
“I've worked as a nurse (15 years), clinical research coordinator (5 years), consultant, writing SOPs for Pharma companies (2 years), then medical writing (7 years and counting). The latter is the best job I've ever had, as it draws on so many different parts of me. I was in the right place at the right time at so many points in my life. I could chalk it up to luck, but I also remind myself of Pasteur's observation: "Chance favors the prepared mind." If you are considering a career in medical writing, don't be afraid to take a risk. Try it, you might like it!”
Becky Hansen
Regulatory writer, MGI PHARMA
Bloomington, Minnesota
Two-Course Package: Enroll in two courses and save 20%
Clinical Trial Reporting + Introduction to Regulatory Writing= $316
Clinical Trial Reporting + Consumer Health Writing = $316
What is the difference between the Clinical Trial Reporting course and the Regulatory Writing Course?
While the Introduction to Regulatory Writing course teaches the drug development and approval process in the US, the Clinical Reporting Course describes how to prepare regulatory documents.
Regulatory Writing Track Package
(Save $100)
Introduction to Regulatory Writing + Clinical Trial Reporting + Epidemiology and Biostatistics = $451
About the Introduction to Regulatory Writing Course
"This online training provided me with convenient and fundamental knowledge of the FDA's regulations for drugs and devices. I would recommend this course to anyone who needs background knowledge or is just starting out learning the regulations."
Dawn Pearson
Seattle, WA