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.
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.
Quality issues - Quality information requirements for the registration of mAb-based products focus on characterization and specifications in areas such as identity, purity, and potency. Information must be provided on the origin and history of the starting materials, and the manufacturing process and its validation must be thoroughly described. Measures taken and validated to control impurities and to clear viruses and other contaminants need to be set out.
Nonclinical issues - Like other drugs, mAb-based products must undergo laboratory and animal testing to define their pharmacological and toxicological effects before they can be studied in humans. The regulatory framework for nonclinical testing of mAb-based products is essentially similar to that for non-biological drugs. Nevertheless, mAbs present special issues, requiring an adaptable, ad hoc scientific approach to nonclinical testing. In this session, we discuss issues such as studies of cross-reactivity with human tissues, choice of species for nonclinical studies, exposure level, and recipient antibody responses.
Clinical issues - MAbs present issues for clinical development and use, such as assessment of immunogenicity, which typically do not arise for small-molecule medicinal products. This session addresses such characteristic issues.
Radiolabelled mAbs - Monoclonal antibodies may form the basis of radiopharmaceuticals for in-vivo diagnostic use or for radiotherapy. In this session we address characteristics of radiolabelled mAbs.
Regulatory submissions - In this session, we identify the pathways for applications to conduct clinical trials and to market a mAb-based product in Europe and the USA, along with relevant legal statutes, regulations, and regulatory guidance.
Assessment - Multiple-choice mastery assessment.
Who will benefit from this module?
This module will benefit regulatory affairs staff and others concerned with the registration of medicinal products based on monoclonal antibodies.
Online Training Program Benefits:
- Immediate access to training: Instructions, username, password and receipt of payment 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 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
- Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization
For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.