Essentials in US Regulatory Affairs Professional Certification Program (PRA00B1)
|Duration: 5.8 hours (the average time to complete the training program, including final assessments).
Credits Hours: 6
Demonstration: Demo an online course.
Certificate: View sample certificate.
PRICE: USD $579.00
This online program includes the essentials for the requirements for obtaining approval for a new drug in the USA (a.k.a. NDA Process), preparing submissions in the CTD (Common Technical Document) Form, and human medicinal products in the US and EU. Courses that must be taken during this program include the following: Regulatory Affairs- The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA; Regulatory Affairs- Preparing Submissions in the Common Technical Document (CTD) Form; Regulatory Affairs- Essentials for Human Medicinal Products- US and EU.
The entire program must be viewed by students in order to pass a multiple-choice, online final assessment. A passing grade of 80% or more is required within 90 days of completing the course (for Professional Certification Programs, it is 180 days). Once all course requirements have been satisfied, a Certificate of Completion is immediately available. Course takers can take the final assessment any number of times, as needed in order to achieve a passing grade.
Benefits of Getting Certified at BioPharma Institute
The BioPharma Institute has proudly provided online training solutions for two decades and assisted individuals from thousands of corporations both abroad and in the United States. We have worked with companies such as Wyeth, 3M, Tyco Healthcare, Astra Zeneca, GE Healthcare, and more in the education of their employees, maintaining training records, and the improvement of their overall quality of service.
The Essentials in US Regulatory Affairs Professional Certification Program Includes the Following Individual Courses:
For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.