Method of Training: Online / Self-paced eLearning.Credit Hours: See individual courses located below for total credits assigned to this program.
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 $1295.00
Document a dedication to your career and job performance by earning a professional certification from Biopharma Institute.Training Provided By: Biopharma Institute
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. Courses that are included in this program are: 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.
In order to earn this professional certification the entire program must be completed by the student, and a score of 75% or better is necessary on each of the online, multiple-choice final assessments. Once all course requirements have been satisfied, a professional certification is immediately achieved. Students can take the final assessments any number of times, as needed, in order to achieve a passing score.
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. Biopharma Institute also assists companies through maintaining training records, educating employees, and improving their overall quality of service. 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: The Benefits of eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
- Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option
- Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization