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Home » Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies (PRA05)

Certification Training
 
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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.
CPD Accredited TrainingCatalog: 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.

Biopharma Institute LogoTraining Program: Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
Training 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. Biopharma Institute Reviews

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.

In this course, we focus on distinctive issues in the production and testing of mAbs, in the context of relevant regulatory guidance. We discuss manufacturing quality, nonclinical, and clinical issues. We address aspects specific to radiolabelled mAbs. Finally, we identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA.

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.


COURSE 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.

COURSE 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
  • Discuss key quality issues in the manufacture of mAb-based products
  • Discuss key issues in nonclinical studies of mAb-based products
  • Discuss key issues in the clinical investigation and use of mAb-based products
  • Identify specific considerations for radiolabelled mAb-based products
  • Identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA

The Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies Course is Included in the Following Professional Certification Programs:


International Pharmaceutical Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ ... Learn more

US Pharmaceutical Regulatory Affairs Professional Certification Program: This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the 'NDA Process'. The program describes preparing submissions using the Comm ... Learn more

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.
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  • 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.

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