Student Login |


Thursday, March 28, 2024
Home » Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies Certification Training


Program/Course ID:PRA005
Enrollment Period:12 months.
Average Learning Time:~.
Additional Resources:Supplemental materials/activities.
Credit Hours:3 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

2024 UPDATE:
This program is currently unavailable for enrollment.

It may have been updated or discontinued.
Check for newer version in our catalog.


.

Browse Our Catalog of 300+ Courses:

Catalog of Courses

Enroll into a Trial Course & Start Learning, Today:

Free Trial Courses

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.

Radiolabeled mAbs - Monoclonal antibodies may form the basis of radiopharmaceuticals for in-vivo diagnostic use or for radiotherapy. In this session we address characteristics of radiolabeled 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
  • 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 radiolabeled mAb-based products
  • Identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA

Use our Search Form to Find What You're Looking For:

  

Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

Have Questions? Contact Us:


Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

Name:
Company:
Phone:
Email:
 
Enter the number from the image above:
Comments:


For quotes or invoices please provide the course(s) and number of students.