|Credits: 3 CPD Credits
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 $195.00
Training Program: Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
Training Provided By: BioPharma Institute
Availability: Immediately available 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, a certificate of completion is immediately available. Course takers can attempt 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 is proud to offer effective, efficient, and convenient training solutions through online courses. We serve professionals working within the healthcare, clinical research, and pharmaceutical industries. Through the years, the Institute has compiled a complete offering of training tools, such as books, recorded seminars, live seminars, online courses, and more.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
Online Training Programs Include:
The Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies course is found in the following professional certification program(s):
Overview – An outline of the module’s scope and objectives, and notes on terminology.
Who will benefit from this module?
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