Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies (PRA05)
 | Method of Training: Online / Self-paced eLearning. Credits: 3 CPD Credits.Duration: ~3 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: Registration of Drugs Based on Monoclonal AntibodiesTraining 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 addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products, such as those based on mAbs, differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture. Procedures for making regulatory submissions for monoclonal antibodies are discussed, such as the marketing authorization application through the CP (Centralized Procedure) in Europe, and by a BLA (Biologics License Application) in the USA. Orphan drug status and its effect on clinical design are also covered. The course addresses the impact of recent developments in production techniques on the regulatory landscape, and will serve as a good source of reference all developments in the future and their practical consequences. 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: Registration of Drugs Based on Monoclonal Antibodies 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.
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- 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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