Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US (PRA06)
 | Method of Training: Online / Self-paced eLearning. Credits: 3.0 CPD Credits.Duration: ~3.0 hour(s). Self-paced Training: 24/7 access to course. Enrollment Period: 3 months.  Catalog: Pharmaceutical Regulatory Affairs.Demonstration: Try one of our FREE courses. Certificate: View sample certificate. PRICE: USD $225.00 |
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute. Training Program: Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon ordering. Description: Online training with immediate access upon enrollment.  This course outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the 'Orange Book' is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasized. The module specifies the content and format requirements for an ANDA submission and describes the FDA's review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law's effects on industry players. This course includes sections regarding bioequivalence, the Orange Book, the review and approval processes of ANDA, ANDA submission, patent certification, ANDA and generic drugs, and a regulatory overview. The entire program must be viewed by students, and a multiple-choice, online final assessments must be completed with a passing grade of 75% or more. Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards. This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student. Benefits of Getting Certified at Biopharma Institute Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education. Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
The Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US Course is Included in the Following Professional Certification Programs:
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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.
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