|Duration: 10 hours (the average time to complete the training program, including final assessments).
Credit Hours: See individual courses for credit hours assigned.
Self-paced Training: 24/7 access to course.
Enrollment Period: 6 months.
Catalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $995.00
This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the ‘NDA Process’. The program describes preparing submissions using the Common Technical Document (CTD) Form and requirements for obtaining approval of human medicinal products in the US (and EU). Courses that are included in this program are the following: Essentials for Human Medicinal Products; Orphan Drug Application; How to Gain Approval to Market Generic Drugs in the US; Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US; Preparing Submissions in the Common Technical Document (CTD) Format; Electronic Common Technical Document (eCTD); The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA; and Registration of Drugs Based on Monoclonal Antibodies.
The entire program must be viewed by students. In order to pass, a score of 80% or better is necessary on each of the multiple-choice, online final assessments. Once all course requirements have been satisfied, a professional certification is immediately achieved. 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
By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. 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.
The US Pharmaceutical Regulatory Affairs Professional Certification Program includes these individual courses:
Online Training Programs Include:
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.