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 $395.00
Demonstrate your dedication to job performance by earning a professional certification from Biopharma Institute.Training Provided By: Biopharma Institute
Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, in laboratory analysis, and in the biotechnology industry itself. 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.
This program will introduce you to monoclonal antibodies, explaining how they work, how they are made, and the many uses to which they are put. Then, it focuses on distinctive issues in the production and testing of mAbs, in the context of relevant regulatory guidance. Discussing manufacturing quality, nonclinical, and clinical issues. The course also addresses aspects specific to radiolabelled mAbs. Finally, it will identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA.
Students participating in this program will be required to take the following Regulatory Affairs courses which are included within the program: 1) Regulatory Affairs: Essentials of Monoclonal Antibodies; and 2) Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies.
Once all course requirements have been satisfied, a professional certification is immediately achieved.
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. Find out what we at the BioPharma Institute can do for your colleagues, you, and/or your employees to further or refresh regulatory education in the biotechnology, pharmaceutical, and healthcare industries.
The Regulatory Affairs for Monoclonal Antibodies 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