Pharmaceutical Regulatory Affairs: Registration of Monoclonal Antibodies

  • ID: 2863529
  • Training
  • Region: Europe, United States
  • Leopink
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The production and use of monoclonal antibodies (mAbs) in the in-vivo diagnosis and treatment of human diseases has evolved exponentially in recent years.

This module identifies the key manufacturing issues and the concerns associated with mAb production. Setting of specifications is also discussed. Requirements on preclinical and clinical studies are set out. Special requirements for radio-labelled mAbs are described. Procedures for making regulatory submissions for mAbs are detailed: marketing authorisation application through the Centralised Procedure (CP) in Europe, and by a Biologics License Application (BLA) in the USA. Orphan drug status and its effect on clinical design are addressed. The module discusses the impact of recent developments in production techniques on the regulatory landscape and will serve as an effective reference source on future developments and their practical consequences.

OBJECTIVES

Identify the regulatory requirements and pathways to licensure in the EU and USA.

Recognise and apply the relevant studies and developmental procedures, critical to establishing safe and effective mAb products.
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Overview
This session briefly describes the regulatory pathways to licensure in the EU and USA.

EU regulatory applications
This session considers the regulatory requirements and pathways in the EU.

US regulatory applications
This session considers the regulatory requirements and pathways in the USA.

Manufacturing issues
This session discusses key manufacturing issues in the development of mAb products.

Setting specifications
This session outlines the tests conducted and appropriate acceptance criteria or test results required to establish specifications to which a drug substance and drug product should conform to be considered acceptable for use in humans.

Preclinical issues
This session discusses key preclinical issues in the development of mAb products.

Clinical issues
This session emphasises developmental aspects crucial to the creation of safe and effective mAb products.

Radio-labelled mAbs
This session identifies the investigational studies on mAbs essential for successful marketing authorisation.

MAbs as orphan drugs
This session provides a basic understanding of the concepts which apply to the registration of mAbs in the European Union and USA.

Assessment
Multiple-choice mastery assessment.
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