Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
 | Enrollment Period: 6 months. Average Learning Time: ~180 minutes. Additional Resources: Supplemental materials/activities. Accredited Program: 3 CPD Credits. Method of Training: Online / Self-paced eLearning. Accessibility: 24/7 access to all program materials. Catalog: Pharmaceutical Regulatory Affairs.Demonstration: Five (5) free trial courses are available. Final Assessment: Multiple choice; unlimited attempts. Certificate: PDF with validation code (See sample). Price: $225.00 USD |
Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma InstituteTraining 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. Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements. Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn. |
Outline: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. | Objectives: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. Objectives
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Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies is included in the following professional certification programs:
 | International Pharmaceutical Regulatory Affairs Professional Certification ProgramCourse ID: PRA00A1Price: $1795.00 (USD) | Learn more | |
 | US Pharmaceutical Regulatory Affairs Professional Certification ProgramCourse ID: PRA00B1Price: $1295.00 (USD) | Learn more |
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- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
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